Trial Outcomes & Findings for A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes (NCT NCT05144984)
NCT ID: NCT05144984
Last Updated: 2026-04-09
Results Overview
Change from baseline (week 0) to week 34 in HbA1c is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
500 participants
Primary outcome timeframe
Baseline (week 0), (week 34)
Results posted on
2026-04-09
Participant Flow
The trial was conducted in 9 countries (86 sites screened/83 randomised participants) as follows: Bulgaria: 6/6; Denmark: 3/3; Greece: 7/7; Hungary: 9/9; Japan: 6/6; Poland: 10/10; Russia: 4/4; Serbia: 3/3; United States of America (USA): 38/35. In addition, Hungary (1 site), Poland (1 site), Serbia (1 site) and USA (5 site) were approved by the institutional review board, but did not screen any participants.
The trial had a 34-week intervention period (10 weeks of dose escalation period and followed by two 12 -week maintenance period), followed by a 5-week follow-up period.
Participant milestones
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
77
|
74
|
77
|
77
|
75
|
59
|
61
|
|
Overall Study
Full Analysis Set (FAS)
|
77
|
74
|
77
|
77
|
75
|
59
|
61
|
|
Overall Study
Safety Analysis Set (SAS)
|
77
|
74
|
77
|
77
|
75
|
59
|
61
|
|
Overall Study
Exposed
|
77
|
74
|
77
|
77
|
75
|
59
|
61
|
|
Overall Study
COMPLETED
|
74
|
72
|
74
|
74
|
72
|
57
|
59
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
3
|
3
|
3
|
2
|
2
|
Reasons for withdrawal
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
3
|
0
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
0
|
3
|
0
|
0
|
|
Overall Study
Investigator decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=77 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=74 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=77 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=77 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=75 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=59 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=61 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59 Years
STANDARD_DEVIATION 11 • n=36 Participants
|
57 Years
STANDARD_DEVIATION 10 • n=78 Participants
|
58 Years
STANDARD_DEVIATION 10 • n=23 Participants
|
59 Years
STANDARD_DEVIATION 9 • n=23 Participants
|
58 Years
STANDARD_DEVIATION 9 • n=24 Participants
|
57 Years
STANDARD_DEVIATION 10 • n=23 Participants
|
58 Years
STANDARD_DEVIATION 9 • n=134 Participants
|
58 Years
STANDARD_DEVIATION 10 • n=12 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=36 Participants
|
33 Participants
n=78 Participants
|
25 Participants
n=23 Participants
|
38 Participants
n=23 Participants
|
27 Participants
n=24 Participants
|
22 Participants
n=23 Participants
|
27 Participants
n=134 Participants
|
198 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=36 Participants
|
41 Participants
n=78 Participants
|
52 Participants
n=23 Participants
|
39 Participants
n=23 Participants
|
48 Participants
n=24 Participants
|
37 Participants
n=23 Participants
|
34 Participants
n=134 Participants
|
302 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=36 Participants
|
7 Participants
n=78 Participants
|
5 Participants
n=23 Participants
|
7 Participants
n=23 Participants
|
10 Participants
n=24 Participants
|
5 Participants
n=23 Participants
|
8 Participants
n=134 Participants
|
54 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=36 Participants
|
67 Participants
n=78 Participants
|
72 Participants
n=23 Participants
|
70 Participants
n=23 Participants
|
65 Participants
n=24 Participants
|
54 Participants
n=23 Participants
|
53 Participants
n=134 Participants
|
446 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=134 Participants
|
1 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
11 Participants
n=36 Participants
|
8 Participants
n=78 Participants
|
9 Participants
n=23 Participants
|
12 Participants
n=23 Participants
|
7 Participants
n=24 Participants
|
7 Participants
n=23 Participants
|
6 Participants
n=134 Participants
|
60 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=134 Participants
|
1 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=36 Participants
|
5 Participants
n=78 Participants
|
2 Participants
n=23 Participants
|
2 Participants
n=23 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=23 Participants
|
0 Participants
n=134 Participants
|
17 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
65 Participants
n=36 Participants
|
60 Participants
n=78 Participants
|
66 Participants
n=23 Participants
|
63 Participants
n=23 Participants
|
64 Participants
n=24 Participants
|
49 Participants
n=23 Participants
|
53 Participants
n=134 Participants
|
420 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=36 Participants
|
1 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=134 Participants
|
1 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0), (week 34)Population: Full Analysis Set (FAS) which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change from baseline (week 0) to week 34 in HbA1c is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=77 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=74 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=77 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=77 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=75 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=59 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=61 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
|
-2.3 Percentage point of HbA1c
Standard Deviation 0.9
|
-2.2 Percentage point of HbA1c
Standard Deviation 0.8
|
-2.2 Percentage point of HbA1c
Standard Deviation 1.1
|
-2.3 Percentage point of HbA1c
Standard Deviation 1.0
|
-2.3 Percentage point of HbA1c
Standard Deviation 0.9
|
-1.1 Percentage point of HbA1c
Standard Deviation 1.1
|
-0.4 Percentage point of HbA1c
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline (week 0), (week 34)Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change from baseline (week 0) to week 34 in FPG is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=61 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=58 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=63 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=63 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=59 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=43 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=36 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
|
-3.9 millimoles per litre (mmol/L)
Standard Deviation 2.6
|
-3.4 millimoles per litre (mmol/L)
Standard Deviation 2.1
|
-3.8 millimoles per litre (mmol/L)
Standard Deviation 2.4
|
-3.8 millimoles per litre (mmol/L)
Standard Deviation 2.9
|
-3.6 millimoles per litre (mmol/L)
Standard Deviation 1.8
|
-1.4 millimoles per litre (mmol/L)
Standard Deviation 2.8
|
-0.1 millimoles per litre (mmol/L)
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline (week 0), (week 34)Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change from baseline (week 0) to week 34 in body weight is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=61 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=60 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=65 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=65 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=60 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=43 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=37 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight (Kilogram [kg])
|
-8.9 Kilogram (kg)
Standard Deviation 5.8
|
-12 Kilogram (kg)
Standard Deviation 7.7
|
-10 Kilogram (kg)
Standard Deviation 5.9
|
-12 Kilogram (kg)
Standard Deviation 5.4
|
-9.8 Kilogram (kg)
Standard Deviation 5.8
|
-4.7 Kilogram (kg)
Standard Deviation 5.1
|
-2.6 Kilogram (kg)
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Baseline (week 0), (week 34)Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Percent change from baseline (week 0) to week 34 in body weight (measured in Kgs) is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=61 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=60 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=65 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=65 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=60 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=43 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=37 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight
|
-9.3 Percent Change of body weight
Standard Deviation 5.8
|
-13 Percent Change of body weight
Standard Deviation 7.3
|
-11 Percent Change of body weight
Standard Deviation 5.8
|
-13 Percent Change of body weight
Standard Deviation 5.4
|
-10 Percent Change of body weight
Standard Deviation 6.3
|
-4.3 Percent Change of body weight
Standard Deviation 4.5
|
-2.7 Percent Change of body weight
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline (week 0), (week 34)Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change from baseline (week 0) to week 34 in waist circumference is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=61 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=60 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=65 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=65 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=60 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=43 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=37 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Waist Circumference
|
-8 Centimeter (cm)
Standard Deviation 5
|
-11 Centimeter (cm)
Standard Deviation 7
|
-9 Centimeter (cm)
Standard Deviation 7
|
-10 Centimeter (cm)
Standard Deviation 7
|
-8 Centimeter (cm)
Standard Deviation 6
|
-5 Centimeter (cm)
Standard Deviation 5
|
-3 Centimeter (cm)
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Baseline (week 0), (week 34)Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change from baseline (week 0) to week 34 in systolic blood pressure is presented. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=61 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=60 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=65 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=65 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=60 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=43 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=37 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP)
|
-6 Millimeters of mercury (mmHg)
Standard Deviation 12
|
-10 Millimeters of mercury (mmHg)
Standard Deviation 14
|
-9 Millimeters of mercury (mmHg)
Standard Deviation 13
|
-13 Millimeters of mercury (mmHg)
Standard Deviation 12
|
-5 Millimeters of mercury (mmHg)
Standard Deviation 16
|
-3 Millimeters of mercury (mmHg)
Standard Deviation 12
|
0 Millimeters of mercury (mmHg)
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Baseline (week 0), (week 34)Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change from baseline (week 0) to week 34 in total cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=61 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=56 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=64 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=64 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=59 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=42 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=36 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline in Total Cholesterol - Ratio to Baseline
|
0.94 Ratio of total cholesterol
Geometric Coefficient of Variation 19.7
|
0.89 Ratio of total cholesterol
Geometric Coefficient of Variation 22.7
|
0.90 Ratio of total cholesterol
Geometric Coefficient of Variation 21.7
|
0.90 Ratio of total cholesterol
Geometric Coefficient of Variation 17.3
|
0.93 Ratio of total cholesterol
Geometric Coefficient of Variation 18.2
|
1.00 Ratio of total cholesterol
Geometric Coefficient of Variation 22.9
|
0.96 Ratio of total cholesterol
Geometric Coefficient of Variation 16.2
|
SECONDARY outcome
Timeframe: Baseline (week 0), (week 34)Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change from baseline (week 0) to week 34 in HDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=61 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=57 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=62 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=64 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=59 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=42 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=35 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
|
1.05 Ratio of HDL cholesterol
Geometric Coefficient of Variation 17.6
|
1.06 Ratio of HDL cholesterol
Geometric Coefficient of Variation 19.8
|
1.07 Ratio of HDL cholesterol
Geometric Coefficient of Variation 16.7
|
1.00 Ratio of HDL cholesterol
Geometric Coefficient of Variation 16.0
|
1.04 Ratio of HDL cholesterol
Geometric Coefficient of Variation 15.6
|
1.04 Ratio of HDL cholesterol
Geometric Coefficient of Variation 16.2
|
1.04 Ratio of HDL cholesterol
Geometric Coefficient of Variation 17.0
|
SECONDARY outcome
Timeframe: Baseline (week 0), (week 34)Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change from baseline (week 0) to week 34 in LDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=60 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=56 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=61 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=63 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=58 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=41 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=34 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
|
0.95 Ratio of LDL cholesterol
Geometric Coefficient of Variation 28.4
|
0.85 Ratio of LDL cholesterol
Geometric Coefficient of Variation 46.5
|
0.91 Ratio of LDL cholesterol
Geometric Coefficient of Variation 37.5
|
0.88 Ratio of LDL cholesterol
Geometric Coefficient of Variation 36.0
|
0.95 Ratio of LDL cholesterol
Geometric Coefficient of Variation 32.2
|
0.96 Ratio of LDL cholesterol
Geometric Coefficient of Variation 53.5
|
0.96 Ratio of LDL cholesterol
Geometric Coefficient of Variation 29.8
|
SECONDARY outcome
Timeframe: Baseline (week 0), (week 34)Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change from baseline (week 0) to week 34 in VLDL cholesterol measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=61 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=56 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=62 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=64 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=59 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=42 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=35 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline in Very-Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline
|
0.75 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 54.0
|
0.76 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 46.4
|
0.72 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 48.9
|
0.78 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 48.2
|
0.72 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 39.9
|
0.95 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 47.9
|
0.86 Ratio of VLDL cholesterol
Geometric Coefficient of Variation 44.5
|
SECONDARY outcome
Timeframe: Baseline (week 0), (week 34)Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change from baseline (week 0) to week 34 in triglycerides measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=61 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=56 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=62 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=64 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=59 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=42 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=35 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline in Triglycerides - Ratio to Baseline
|
0.75 Ratio of triglycerides
Geometric Coefficient of Variation 53.9
|
0.76 Ratio of triglycerides
Geometric Coefficient of Variation 46.1
|
0.72 Ratio of triglycerides
Geometric Coefficient of Variation 49.1
|
0.78 Ratio of triglycerides
Geometric Coefficient of Variation 47.8
|
0.72 Ratio of triglycerides
Geometric Coefficient of Variation 40.0
|
0.96 Ratio of triglycerides
Geometric Coefficient of Variation 47.8
|
0.86 Ratio of triglycerides
Geometric Coefficient of Variation 44.7
|
SECONDARY outcome
Timeframe: Baseline (week 0), (week 34)Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in baseline (week 0) to week 34 in free fatty acids measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=61 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=57 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=64 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=65 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=58 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=43 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=35 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline in Free Fatty Acids - Ratio to Baseline
|
0.85 Ratio of free fatty acids
Geometric Coefficient of Variation 76.1
|
0.74 Ratio of free fatty acids
Geometric Coefficient of Variation 66.0
|
0.77 Ratio of free fatty acids
Geometric Coefficient of Variation 43.5
|
0.75 Ratio of free fatty acids
Geometric Coefficient of Variation 64.9
|
0.88 Ratio of free fatty acids
Geometric Coefficient of Variation 42.3
|
0.96 Ratio of free fatty acids
Geometric Coefficient of Variation 51.1
|
0.91 Ratio of free fatty acids
Geometric Coefficient of Variation 47.3
|
SECONDARY outcome
Timeframe: Baseline (week 0), (week 34)Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change from baseline (week 0) to week 34 in ApoB measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=60 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=58 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=65 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=65 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=59 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=43 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=36 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline in Apolipoprotein B (ApoB) - Ratio to Baseline
|
0.90 Ratio of ApoB
Geometric Coefficient of Variation 22.8
|
0.84 Ratio of ApoB
Geometric Coefficient of Variation 25.7
|
0.85 Ratio of ApoB
Geometric Coefficient of Variation 23.5
|
0.85 Ratio of ApoB
Geometric Coefficient of Variation 22.1
|
0.91 Ratio of ApoB
Geometric Coefficient of Variation 18.4
|
1.00 Ratio of ApoB
Geometric Coefficient of Variation 28.2
|
0.94 Ratio of ApoB
Geometric Coefficient of Variation 14.7
|
SECONDARY outcome
Timeframe: Baseline (week 0), (week 34)Population: FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change from baseline (week 0) to week 34 in hsCRP measured as milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from on treatment without rescue medication. On treatment without rescue medication: the time period where all observed data for which participants are considered exposed to randomised treatment and have not initiated any rescue medication.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=61 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=57 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=64 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=65 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=59 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=43 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=35 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Relative Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
|
0.56 Ratio of hsCRP
Geometric Coefficient of Variation 107.0
|
0.54 Ratio of hsCRP
Geometric Coefficient of Variation 136.9
|
0.64 Ratio of hsCRP
Geometric Coefficient of Variation 147.9
|
0.66 Ratio of hsCRP
Geometric Coefficient of Variation 135.5
|
0.61 Ratio of hsCRP
Geometric Coefficient of Variation 141.5
|
0.82 Ratio of hsCRP
Geometric Coefficient of Variation 89.7
|
0.93 Ratio of hsCRP
Geometric Coefficient of Variation 201.6
|
SECONDARY outcome
Timeframe: Baseline (week 0) to (week 39)Population: Safety Analysis Set (SAS) included all participants exposed to randomised treatment.
An adverse event (AE) defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of an investigational medicinal product (IMP). All AEs mentioned are treatment emergent adverse events (TEAE) defined as an event with onset during the on treatment period. On treatment period: the time period where all observed data for which subjects are considered exposed to randomised treatment.
Outcome measures
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=77 Participants
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=74 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=77 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=77 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=75 Participants
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=59 Participants
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=61 Participants
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Treatment-Emergent Adverse Events (TEAEs)
|
229 Events
|
304 Events
|
206 Events
|
308 Events
|
271 Events
|
240 Events
|
95 Events
|
Adverse Events
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
Serious events: 6 serious events
Other events: 40 other events
Deaths: 0 deaths
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
Serious events: 5 serious events
Other events: 37 other events
Deaths: 0 deaths
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=77 participants at risk
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=74 participants at risk
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=77 participants at risk
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=77 participants at risk
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=75 participants at risk
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=59 participants at risk
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=61 participants at risk
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/75 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.7%
1/59 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.7%
1/59 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/75 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/75 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Vascular disorders
Giant cell arteritis
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.6%
1/61 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Endocrine disorders
Parathyroid cyst
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.6%
1/61 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/75 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/75 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Infections and infestations
Vascular device infection
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
Other adverse events
| Measure |
Semaglutide 2.4 mg + NNC0480-0389 2.4 mg
n=77 participants at risk
Participants received once weekly 2.4 milligram (mg) semaglutide co-administered with 2.4 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/0.5 mg from week 2 to week 6, 1.0 mg/1.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/2.0 mg from week 10 to week 22) and (2.4 mg/ 2.4 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 7.2 mg
n=74 participants at risk
Participants received once weekly 2.4 mg semaglutide co-administered with 7.2 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/0.8 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/1.5 mg from week 2 to week 6, 1.0 mg/3.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/6.0 mg from week 10 to week 22) and (2.4 mg/ 7.2 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 12.0 mg
n=77 participants at risk
Participants received once weekly 2.4 mg semaglutide co-administered with 12.0 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/1.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/2.5 mg from week 2 to week 6, 1.0 mg/5.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/10.0 mg from week 10 to week 22) and (2.4 mg/ 12.0 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + NNC0480-0389 21.6 mg
n=77 participants at risk
Participants received once weekly 2.4 mg semaglutide co-administered with 21.6 mg NNC0480-0389 subcutaneously for 34 weeks. Participants received once weekly semaglutide co-administered with NNC0480-0389 subcutaneously in dose escalation manner for 10-weeks followed by two 12-weeks maintenance periods: (0.25 mg semaglutide/2.3 mg NNC0480-0389 from week 0 to week 2, 0.5 mg/4.5 mg from week 2 to week 6, 1.0 mg/9.0 mg from week 6 to week 10) and followed by two 12-weeks maintenance periods (2.0 mg/18.0 mg from week 10 to week 22) and (2.4 mg/ 21.6 mg from week 22 to week 34).
|
Semaglutide 2.4 mg + Placebo (NNC0480-0389)
n=75 participants at risk
Participants received once weekly 2.4 mg semaglutide co-administered with placebo matched to NNC0480-0389 subcutaneously for 34 weeks.
|
NNC0480-0389 21.6 mg + Placebo (Semaglutide)
n=59 participants at risk
Participants received once weekly 21.6 mg NNC0480-0389 co-administered with placebo matched to semaglutide subcutaneously for 34 weeks.
|
Placebo
n=61 participants at risk
Participants received subcutaneous dose of semaglutide matched placebo and NNC0480-0389 matched placebo once weekly for 34 weeks.
|
|---|---|---|---|---|---|---|---|
|
Investigations
Amylase increased
|
3.9%
3/77 • Number of events 3 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
4.1%
3/74 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
6.5%
5/77 • Number of events 5 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/75 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.7%
1/59 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
General disorders
Asthenia
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 3 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
5.2%
4/77 • Number of events 7 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.7%
2/75 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.4%
2/59 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
6.8%
5/74 • Number of events 5 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.9%
3/77 • Number of events 3 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/75 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.7%
1/59 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.3%
2/61 • Number of events 3 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Infections and infestations
COVID-19
|
7.8%
6/77 • Number of events 7 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
5.4%
4/74 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
7.8%
6/77 • Number of events 6 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
11.7%
9/77 • Number of events 9 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
9.3%
7/75 • Number of events 7 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.4%
2/59 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
13.1%
8/61 • Number of events 8 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Gastrointestinal disorders
Constipation
|
5.2%
4/77 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
8.1%
6/74 • Number of events 7 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
9.1%
7/77 • Number of events 7 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
7.8%
6/77 • Number of events 6 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
5.3%
4/75 • Number of events 6 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
5.1%
3/59 • Number of events 3 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.6%
1/61 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.2%
4/77 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
10.8%
8/74 • Number of events 8 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.9%
3/77 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
9.1%
7/77 • Number of events 7 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
10.7%
8/75 • Number of events 8 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.6%
1/61 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
11/77 • Number of events 25 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
21.6%
16/74 • Number of events 30 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
14.3%
11/77 • Number of events 22 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
13.0%
10/77 • Number of events 18 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
18.7%
14/75 • Number of events 21 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
8.5%
5/59 • Number of events 12 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
11.5%
7/61 • Number of events 9 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Nervous system disorders
Dizziness
|
5.2%
4/77 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
4.1%
3/74 • Number of events 3 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
5.2%
4/77 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.9%
3/77 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
6.7%
5/75 • Number of events 6 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.6%
1/61 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.2%
4/77 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
4.1%
3/74 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
5.3%
4/75 • Number of events 6 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.7%
1/59 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Gastrointestinal disorders
Eructation
|
1.3%
1/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.7%
2/74 • Number of events 5 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
6.7%
5/75 • Number of events 6 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.6%
1/61 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
General disorders
Fatigue
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.9%
3/77 • Number of events 3 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
5.3%
4/75 • Number of events 9 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.4%
2/59 • Number of events 3 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.6%
1/61 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.3%
1/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.7%
2/74 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
6.7%
5/75 • Number of events 6 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.6%
1/61 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Nervous system disorders
Headache
|
7.8%
6/77 • Number of events 9 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
4.1%
3/74 • Number of events 3 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
6.5%
5/77 • Number of events 7 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.9%
3/77 • Number of events 6 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
9.3%
7/75 • Number of events 16 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
8.5%
5/59 • Number of events 12 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.3%
2/61 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/74 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.4%
2/59 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
9.8%
6/61 • Number of events 6 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Vascular disorders
Hypotension
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
5.4%
4/74 • Number of events 5 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/75 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.7%
1/59 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
General disorders
Injection site erythema
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
5.2%
4/77 • Number of events 10 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
7.8%
6/77 • Number of events 25 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
10.2%
6/59 • Number of events 23 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
General disorders
Injection site pruritus
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.4%
1/74 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
6.5%
5/77 • Number of events 38 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
8.5%
5/59 • Number of events 61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
General disorders
Injection site reaction
|
1.3%
1/77 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.7%
2/74 • Number of events 3 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.3%
1/77 • Number of events 3 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/75 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
10.2%
6/59 • Number of events 13 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
0.00%
0/61 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Investigations
Lipase increased
|
5.2%
4/77 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
12.2%
9/74 • Number of events 10 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
9.1%
7/77 • Number of events 8 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.7%
2/75 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.7%
1/59 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.3%
2/61 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
3/77 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
5.4%
4/74 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
5.2%
4/77 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
4.0%
3/75 • Number of events 3 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.4%
2/59 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.3%
2/61 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Gastrointestinal disorders
Nausea
|
19.5%
15/77 • Number of events 21 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
12.2%
9/74 • Number of events 25 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
6.5%
5/77 • Number of events 8 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
13.0%
10/77 • Number of events 13 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
22.7%
17/75 • Number of events 29 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
6.8%
4/59 • Number of events 8 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.6%
1/61 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/77 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.7%
2/74 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.6%
2/77 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
2.7%
2/75 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
6.8%
4/59 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.6%
1/61 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
4/77 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
9.5%
7/74 • Number of events 9 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
5.2%
4/77 • Number of events 4 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
6.5%
5/77 • Number of events 7 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
13.3%
10/75 • Number of events 12 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
3.4%
2/59 • Number of events 2 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
1.6%
1/61 • Number of events 1 • From baseline (week 0) to week 39
All presented AEs are TEAEs, defined as an event with onset during the on treatment period. Results are based on the SAS which included all participants exposed to randomised treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER