Trial Outcomes & Findings for A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight (NCT NCT06124807)
NCT ID: NCT06124807
Last Updated: 2026-04-21
Results Overview
Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\*Time + Strata\*Time + Treatment\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\<=30, \>30 kg/m\^2).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
179 participants
Primary outcome timeframe
Baseline, Week 32
Results posted on
2026-04-21
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 Milligrams (mg) Mazdutide
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
32
|
48
|
51
|
|
Overall Study
Safety Population (Participants Who Are Exposed to at Least One Dose of Study Intervention)
|
47
|
32
|
47
|
51
|
|
Overall Study
COMPLETED
|
29
|
28
|
37
|
34
|
|
Overall Study
NOT COMPLETED
|
19
|
4
|
11
|
17
|
Reasons for withdrawal
| Measure |
Placebo
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 Milligrams (mg) Mazdutide
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
1
|
3
|
|
Overall Study
Inadvertent enrollment
|
1
|
0
|
1
|
0
|
|
Overall Study
Met early discontinuation criteria
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
1
|
4
|
4
|
|
Overall Study
Schedule conflict
|
1
|
0
|
0
|
0
|
|
Overall Study
Did not return for the scheduled safety follow-up
|
2
|
0
|
3
|
4
|
Baseline Characteristics
A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight
Baseline characteristics by cohort
| Measure |
Placebo
n=48 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=32 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=48 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=51 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
Total
n=179 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 12.5 • n=13 Participants
|
48.6 years
STANDARD_DEVIATION 13.8 • n=13 Participants
|
48.4 years
STANDARD_DEVIATION 10.1 • n=26 Participants
|
48.3 years
STANDARD_DEVIATION 13.3 • n=15 Participants
|
47.7 years
STANDARD_DEVIATION 12.3 • n=25 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=13 Participants
|
21 Participants
n=13 Participants
|
32 Participants
n=26 Participants
|
33 Participants
n=15 Participants
|
118 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=13 Participants
|
11 Participants
n=13 Participants
|
16 Participants
n=26 Participants
|
18 Participants
n=15 Participants
|
61 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=13 Participants
|
9 Participants
n=13 Participants
|
7 Participants
n=26 Participants
|
11 Participants
n=15 Participants
|
41 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=13 Participants
|
23 Participants
n=13 Participants
|
40 Participants
n=26 Participants
|
38 Participants
n=15 Participants
|
135 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=26 Participants
|
2 Participants
n=15 Participants
|
3 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=13 Participants
|
3 Participants
n=13 Participants
|
2 Participants
n=26 Participants
|
2 Participants
n=15 Participants
|
9 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=13 Participants
|
7 Participants
n=13 Participants
|
11 Participants
n=26 Participants
|
7 Participants
n=15 Participants
|
34 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=13 Participants
|
20 Participants
n=13 Participants
|
33 Participants
n=26 Participants
|
38 Participants
n=15 Participants
|
125 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=26 Participants
|
2 Participants
n=15 Participants
|
6 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
2 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=15 Participants
|
4 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
48 Participants
n=13 Participants
|
32 Participants
n=13 Participants
|
48 Participants
n=26 Participants
|
51 Participants
n=15 Participants
|
179 Participants
n=25 Participants
|
|
Body Weight
|
103.1 Kilograms (Kg)
STANDARD_DEVIATION 21.20 • n=13 Participants
|
109.8 Kilograms (Kg)
STANDARD_DEVIATION 17.71 • n=13 Participants
|
108.5 Kilograms (Kg)
STANDARD_DEVIATION 21.70 • n=26 Participants
|
109.7 Kilograms (Kg)
STANDARD_DEVIATION 20.67 • n=15 Participants
|
107.6 Kilograms (Kg)
STANDARD_DEVIATION 20.63 • n=25 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 32Population: All randomized participants who were evaluable for this outcome.
Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\*Time + Strata\*Time + Treatment\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\<=30, \>30 kg/m\^2).
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=32 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=48 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=51 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 32
|
-0.85 percent change
Standard Error 0.787
|
-7.33 percent change
Standard Error 0.937
|
-15.6 percent change
Standard Error 0.744
|
-18.1 percent change
Standard Error 0.965
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: All randomized participants who were evaluable for this outcome.
Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\*Time + Strata\*Time + Treatment\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Percent Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\<=30, \>30 kg/m\^2).
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=32 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=48 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=51 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 48
|
-0.047 percent change
Standard Error 1.059
|
-10.54 percent change
Standard Error 1.498
|
-19.2 percent change
Standard Error 1.076
|
-22.3 percent change
Standard Error 1.424
|
SECONDARY outcome
Timeframe: Baseline, Week 32, Week 48Population: All randomized participants who were evaluable for this outcome.
Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\*Time + Strata\*Time + Treatment\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\<=30, \>30 kg/m\^2).
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=32 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=48 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=51 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Change From Baseline in Body Weight
Week 32
|
-0.98 Kilograms (Kg)
Standard Error 0.882
|
-7.79 Kilograms (Kg)
Standard Error 1.011
|
-16.1 Kilograms (Kg)
Standard Error 0.779
|
-19.2 Kilograms (Kg)
Standard Error 1.037
|
|
Change From Baseline in Body Weight
Week 48
|
-0.15 Kilograms (Kg)
Standard Error 1.195
|
-11.15 Kilograms (Kg)
Standard Error 1.601
|
-19.7 Kilograms (Kg)
Standard Error 1.127
|
-23.9 Kilograms (Kg)
Standard Error 1.542
|
SECONDARY outcome
Timeframe: Baseline, Week 32, Week 48Population: All randomized participants who were evaluable for this outcome.
Mean percentage of participants who achieve ≥5% body weight reduction was calculated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=32 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=48 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=51 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Mean Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Week 32
|
23.97 percentage of participants
Standard Error 6.99
|
67.64 percentage of participants
Standard Error 8.70
|
96.10 percentage of participants
Standard Error 3.57
|
92.23 percentage of participants
Standard Error 4.30
|
|
Mean Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Week 48
|
25.96 percentage of participants
Standard Error 7.13
|
74.77 percentage of participants
Standard Error 8.27
|
95.91 percentage of participants
Standard Error 3.46
|
91.90 percentage of participants
Standard Error 4.95
|
SECONDARY outcome
Timeframe: Baseline, Week 32, Week 48Population: All randomized participants who were evaluable for this outcome.
Mean percentage of participants who achieve ≥10% body weight reduction was calculated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=32 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=48 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=51 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Mean Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Week 32
|
8.73 percentage of participants
Standard Error 4.53
|
45.43 percentage of participants
Standard Error 9.18
|
85.95 percentage of participants
Standard Error 5.67
|
77.08 percentage of participants
Standard Error 6.45
|
|
Mean Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Week 48
|
13.77 percentage of participants
Standard Error 5.81
|
57.86 percentage of participants
Standard Error 9.14
|
83.97 percentage of participants
Standard Error 5.70
|
80.73 percentage of participants
Standard Error 6.43
|
SECONDARY outcome
Timeframe: Baseline, Week 32, Week 48Population: All randomized participants who were evaluable for this outcome.
Least squares means were calculated using an MMRM model for post-baseline measures: Variable = Baseline\*Time + Strata\*Time + Treatment\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\<=30, \>30 kg/m\^2).
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=32 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=48 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=51 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Change From Baseline in Body Mass Index (BMI)
Week 32
|
-0.32 kilogram per square metre (kg/m^2)
Standard Error 0.305
|
-2.84 kilogram per square metre (kg/m^2)
Standard Error 0.376
|
-5.81 kilogram per square metre (kg/m^2)
Standard Error 0.281
|
-6.86 kilogram per square metre (kg/m^2)
Standard Error 0.372
|
|
Change From Baseline in Body Mass Index (BMI)
Week 48
|
-0.017 kilogram per square metre (kg/m^2)
Standard Error 0.430
|
-4.07 kilogram per square metre (kg/m^2)
Standard Error 0.609
|
-7.15 kilogram per square metre (kg/m^2)
Standard Error 0.409
|
-8.53 kilogram per square metre (kg/m^2)
Standard Error 0.559
|
SECONDARY outcome
Timeframe: Baseline up to week 56Population: All participants who are exposed to at least one dose of study intervention and had least one non-missing test result for ADA for each of the baseline period and the post-baseline period.
Blood samples were tested to determine if a participant reacted to Mazdutide by producing anti-Mazdutide antibodies. A participant is TE ADA evaluable if there is at least one non-missing test result for ADA for each of the baseline period and the postbaseline period. A TE ADA evaluable participant is considered to be TE ADA+ if the participant has at least one postbaseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the subject is TE ADA+ if there is at least one postbaseline result of ADA Present with titer \>=1:20.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=32 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=47 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=51 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Anti-drug Antibodies (TE-ADAs)
|
5 Participants
|
3 Participants
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 32, Week 48; Post dose (2 to 6 hours after dosing) at Week 0, Week 12, Week 24Population: All randomized participants who had evaluable PK data for this outcome. Per protocol, PK data was pre-specified to be analyzed separately by individual target doses.
PK samples were analyzed using a population PK approach to estimate AUC at steady state. Data presented are Geometric mean with 90% prediction interval.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=32 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=47 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=51 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mazdutide at Steady State
|
93800 nanogram*hour per milliliter (ng*h/mL)
Interval 44800.0 to 199000.0
|
190000 nanogram*hour per milliliter (ng*h/mL)
Interval 90600.0 to 404000.0
|
340000 nanogram*hour per milliliter (ng*h/mL)
Interval 158000.0 to 758000.0
|
537000 nanogram*hour per milliliter (ng*h/mL)
Interval 240000.0 to 1210000.0
|
SECONDARY outcome
Timeframe: Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 32, Week 48; Post dose (2 to 6 hours after dosing) at Week 0, Week 12, Week 24Population: All randomized participants who had evaluable PK data for this outcome. Per protocol, PK data was pre-specified to be analyzed separately by individual target doses.
PK samples were analyzed using a population PK approach to estimate Cmax at steady state. Data presented are Geometric mean with 90% prediction interval.
Outcome measures
| Measure |
Placebo
n=32 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=32 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=47 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=51 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of Mazdutide at Steady State
|
694 nanogram per milliliter (ng/mL)
Interval 356.0 to 1330.0
|
1420 nanogram per milliliter (ng/mL)
Interval 735.0 to 2880.0
|
2530 nanogram per milliliter (ng/mL)
Interval 1290.0 to 5380.0
|
4020 nanogram per milliliter (ng/mL)
Interval 2000.0 to 8020.0
|
SECONDARY outcome
Timeframe: Baseline, Week 32, Week 48Population: All randomized participants who were evaluable for this outcome.
Least squares means were calculated using an MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = Treatment\*Time + log(Baseline)\*Time + Strata\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\<=30, \>30 kg/m\^2).
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=22 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=33 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=31 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Change From Baseline in Liver Fat Content (LFC) by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) in Participants With Baseline LFC >=5%
Week 32
|
-1.62 Percentage of liver fat content
Standard Error 0.770
|
-6.15 Percentage of liver fat content
Standard Error 0.615
|
-7.78 Percentage of liver fat content
Standard Error 0.462
|
-7.91 Percentage of liver fat content
Standard Error 0.548
|
|
Change From Baseline in Liver Fat Content (LFC) by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) in Participants With Baseline LFC >=5%
Week 48
|
-1.35 Percentage of liver fat content
Standard Error 0.872
|
-7.81 Percentage of liver fat content
Standard Error 0.444
|
-8.07 Percentage of liver fat content
Standard Error 0.448
|
-7.74 Percentage of liver fat content
Standard Error 0.670
|
SECONDARY outcome
Timeframe: Baseline, Week 32, Week 48Population: All randomized participants who were evaluable for this outcome.
Least squares means were calculated using an MMRM model for post-baseline measures: log (Actual Measurement/Baseline) = Treatment\*Time + log (Baseline)\*Time + Strata\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\<=30, \>30 kg/m\^2).
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=22 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=33 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=31 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=5%
Week 32
|
-14.1 percent change
Standard Error 6.70
|
-53.5 percent change
Standard Error 5.35
|
-67.7 percent change
Standard Error 4.02
|
-68.8 percent change
Standard Error 4.76
|
|
Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=5%
Week 48
|
-11.7 percent change
Standard Error 7.58
|
-68.0 percent change
Standard Error 3.86
|
-70.2 percent change
Standard Error 3.90
|
-67.4 percent change
Standard Error 5.83
|
SECONDARY outcome
Timeframe: Baseline, Week 32, Week 48Population: All randomized participants who were evaluable for this outcome.
Least squares means were calculated using an MMRM model for post-baseline measures: log (Actual Measurement/Baseline) = Treatment\*Time + log (Baseline)\*Time + Strata\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\<=30, \>30 kg/m\^2).
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=11 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=19 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=18 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10%
Week 32
|
-4.3 Percentage of liver fat content
Standard Error 1.48
|
-9.3 Percentage of liver fat content
Standard Error 1.43
|
-13.8 Percentage of liver fat content
Standard Error 0.49
|
-12.8 Percentage of liver fat content
Standard Error 1.06
|
|
Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10%
Week 48
|
-4.6 Percentage of liver fat content
Standard Error 1.67
|
-12.4 Percentage of liver fat content
Standard Error 0.95
|
-13.9 Percentage of liver fat content
Standard Error 0.62
|
-12.6 Percentage of liver fat content
Standard Error 1.40
|
SECONDARY outcome
Timeframe: Baseline, Week 32, Week 48Population: All randomized participants who were evaluable for this outcome.
Least squares means were calculated using an MMRM model for post-baseline measures: log (Actual Measurement/Baseline) = Treatment\*Time + log (Baseline)\*Time + Strata\*Time, where Treatment and Strata are factors. Variance-Covariance structure (Change from Baseline) = Unstructured. Strata is defined by joint levels of Sex and Baseline BMI (\<=30, \>30 kg/m\^2).
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=11 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=19 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=18 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10%
Week 32
|
-24.7 percent change
Standard Error 8.51
|
-53.4 percent change
Standard Error 8.26
|
-79.5 percent change
Standard Error 2.80
|
-73.6 percent change
Standard Error 6.08
|
|
Percent Change From Baseline in Liver Fat Content by MRI-PDFF in Participants With Baseline LFC >=10%
Week 48
|
-26.3 percent change
Standard Error 9.63
|
-71.2 percent change
Standard Error 5.45
|
-80.2 percent change
Standard Error 3.55
|
-72.3 percent change
Standard Error 8.09
|
SECONDARY outcome
Timeframe: Baseline, Week 32, Week 48Population: All randomized participants who were evaluable for this outcome.
mean Percentage of participants with baseline liver fat content (LFC) \>= 5% who achieved \>30% relative reduction in LFC was estimated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.
Outcome measures
| Measure |
Placebo
n=36 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=22 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=33 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=31 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Mean Percentage of Participants With Baseline Liver Fat Content (LFC) >= 5% Who Achieved >30% Relative Reduction in LFC
Week 32
|
24.93 percentage of participants
Standard Error 8.67
|
73.97 percentage of participants
Standard Error 10.29
|
84.93 percentage of participants
Standard Error 6.39
|
83.40 percentage of participants
Standard Error 7.41
|
|
Mean Percentage of Participants With Baseline Liver Fat Content (LFC) >= 5% Who Achieved >30% Relative Reduction in LFC
Week 48
|
30.04 percentage of participants
Standard Error 9.16
|
87.73 percentage of participants
Standard Error 8.58
|
85.70 percentage of participants
Standard Error 7.19
|
84.23 percentage of participants
Standard Error 8.82
|
SECONDARY outcome
Timeframe: Baseline, Week 32, Week 48Population: All randomized participants who were evaluable for this outcome.
Mean Percentage of participants with baseline liver fat content (LFC) \>=10% who achieved \>30% relative reduction in LFC was estimated using imputed data with the logistic regression model Variable = Baseline + Treatment + Strata (Sex), where Treatment and Strata (Sex) are factors. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 32 and week 48 respectively in imputed data sets using Rubin's rule.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.
|
3/6 mg Mazdutide
n=11 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=19 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=18 Participants
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Mean Percentage of Participants With Baseline Liver Fat Content (LFC) >=10% Who Achieved >30% Relative Reduction in LFC
Week 48
|
36.82 percentage of participants
Standard Error 13.36
|
86.64 percentage of participants
Standard Error 10.88
|
90.46 percentage of participants
Standard Error 7.93
|
78.36 percentage of participants
Standard Error 12.46
|
|
Mean Percentage of Participants With Baseline Liver Fat Content (LFC) >=10% Who Achieved >30% Relative Reduction in LFC
Week 32
|
38.57 percentage of participants
Standard Error 12.98
|
71.95 percentage of participants
Standard Error 14.13
|
99.71 percentage of participants
Standard Error 1.92
|
92.04 percentage of participants
Standard Error 7.73
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
3/6 Milligrams (mg) Mazdutide
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
10 mg Mazdutide
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
16 mg Mazdutide
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=47 participants at risk
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48
|
3/6 Milligrams (mg) Mazdutide
n=32 participants at risk
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=47 participants at risk
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=51 participants at risk
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic necrosis
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
Placebo
n=47 participants at risk
Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48
|
3/6 Milligrams (mg) Mazdutide
n=32 participants at risk
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
|
10 mg Mazdutide
n=47 participants at risk
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
|
16 mg Mazdutide
n=51 participants at risk
Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then 16 mg from Weeks 20-48.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.4%
3/47 • Number of events 4 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.8%
4/51 • Number of events 6 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
2/47 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.5%
4/47 • Number of events 4 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.8%
6/51 • Number of events 10 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.3%
2/47 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 4 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
10.6%
5/47 • Number of events 5 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
21.9%
7/32 • Number of events 8 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
29.8%
14/47 • Number of events 17 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
37.3%
19/51 • Number of events 21 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.8%
6/47 • Number of events 7 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
28.1%
9/32 • Number of events 15 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
25.5%
12/47 • Number of events 16 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
25.5%
13/51 • Number of events 29 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
6.4%
3/47 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
2/47 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.6%
5/47 • Number of events 6 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.8%
4/51 • Number of events 5 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.8%
4/51 • Number of events 5 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.4%
3/32 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
25.5%
12/47 • Number of events 15 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
43.8%
14/32 • Number of events 21 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
46.8%
22/47 • Number of events 36 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
66.7%
34/51 • Number of events 89 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
21.9%
7/32 • Number of events 7 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.8%
6/47 • Number of events 9 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
47.1%
24/51 • Number of events 55 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
6.4%
3/47 • Number of events 5 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
18.8%
6/32 • Number of events 8 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
23.4%
11/47 • Number of events 25 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
25.5%
13/51 • Number of events 16 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
2.1%
1/47 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.9%
2/51 • Number of events 5 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
6.4%
3/47 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.4%
3/32 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bacterial vaginosis
|
6.5%
2/31 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/21 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
1/31 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/33 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
12.8%
6/47 • Number of events 7 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
15.7%
8/51 • Number of events 8 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.4%
3/32 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.8%
4/51 • Number of events 4 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
3/47 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
4.3%
2/47 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
3/47 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.9%
7/47 • Number of events 8 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
18.8%
6/32 • Number of events 7 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
14.9%
7/47 • Number of events 7 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.8%
6/51 • Number of events 6 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.4%
3/32 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.8%
6/47 • Number of events 7 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.8%
4/51 • Number of events 4 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.4%
3/32 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
3/47 • Number of events 4 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
8.5%
4/47 • Number of events 4 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Vitamin b12 deficiency
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.4%
3/47 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
4/32 • Number of events 5 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.8%
4/51 • Number of events 4 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/16 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
6.4%
3/47 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
3/47 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
17.6%
9/51 • Number of events 10 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
10.6%
5/47 • Number of events 6 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
4/32 • Number of events 4 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.5%
4/47 • Number of events 5 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.8%
5/51 • Number of events 5 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
4.3%
2/47 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
3/47 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal cyst
|
6.4%
3/47 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 4 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/18 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Prostatic mass
|
0.00%
0/16 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
6.2%
1/16 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/11 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/16 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
2/18 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
1/51 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
3/47 • Number of events 3 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/51 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
0.00%
0/47 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/32 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
3/51 • Number of events 4 • Baseline up to Week 56
All participants who are exposed to at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60