Trial Outcomes & Findings for Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range (NCT NCT05564117)
NCT ID: NCT05564117
Last Updated: 2026-02-25
Results Overview
Percentage change in body weight from baseline (week 0) to end of treatment (week 64) is presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
307 participants
Primary outcome timeframe
Baseline (week 0), end of treatment (week 64)
Results posted on
2026-02-25
Participant Flow
The trial was conducted at 22 sites in 4 countries (Canada, Germany, Poland, and United States).
Participants were randomised in 2:1 ratio to receive once daily oral semaglutide 25 milligram (mg) or placebo matched to semaglutide. The trial had a 64-week treatment period (12 weeks of dose escalation period and 52 weeks of maintenance period) followed by a 7-week follow-up period.
Participant milestones
| Measure |
Oral Semaglutide 25 mg
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Overall Study
STARTED
|
205
|
102
|
|
Overall Study
Full Analysis Set
|
205
|
102
|
|
Overall Study
Safety Analysis Set
|
204
|
102
|
|
Overall Study
COMPLETED
|
196
|
94
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
Oral Semaglutide 25 mg
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range
Baseline characteristics by cohort
| Measure |
Oral Semaglutide 25 mg
n=205 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=102 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
Total
n=307 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 Years
STANDARD_DEVIATION 13 • n=24 Participants
|
47 Years
STANDARD_DEVIATION 13 • n=20 Participants
|
48 Years
STANDARD_DEVIATION 13 • n=40 Participants
|
|
Sex: Female, Male
Female
|
155 Participants
n=24 Participants
|
87 Participants
n=20 Participants
|
242 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=24 Participants
|
15 Participants
n=20 Participants
|
65 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=24 Participants
|
7 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
188 Participants
n=24 Participants
|
95 Participants
n=20 Participants
|
283 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=24 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 Participants
n=24 Participants
|
9 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
190 Participants
n=24 Participants
|
91 Participants
n=20 Participants
|
281 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=24 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Percentage change in body weight from baseline (week 0) to end of treatment (week 64) is presented.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=192 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=90 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Percentage Change in Body Weight
|
-14.4 Percentage change in body weight
Standard Deviation 10.5
|
-2.5 Percentage change in body weight
Standard Deviation 7.9
|
PRIMARY outcome
Timeframe: At end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=192 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=90 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)
Yes
|
152 Participants
|
28 Participants
|
|
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)
No
|
40 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Number of participants who achieved ≥ 10% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=192 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=90 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)
Yes
|
121 Participants
|
13 Participants
|
|
Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)
No
|
71 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Number of participants who achieved ≥ 15% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 15% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 15% weight reduction.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=192 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=90 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Number of Participants Who Achieved Body Weight Reduction ≥ 15% (Yes/No)
Yes
|
96 Participants
|
5 Participants
|
|
Number of Participants Who Achieved Body Weight Reduction ≥ 15% (Yes/No)
No
|
96 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Number of participants who achieved ≥ 20% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 20% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 20% weight reduction.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=192 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=90 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Number of Participants Who Achieved Body Weight Reduction ≥ 20% (Yes/No)
Yes
|
57 Participants
|
3 Participants
|
|
Number of Participants Who Achieved Body Weight Reduction ≥ 20% (Yes/No)
No
|
135 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in physical function domain score IWQOL-Lite-CT from baseline (week 0) to the end of treatment (week 64) is presented. IWQOL-Lite-CT is a 20-item obesity-specific PRO measures used to assess the impact of body weight changes on patient's physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial functioning (13 items) in 3 composite scores (Physical Function, Physical and Psychosocial) and a Total score, all ranging from 0 to 100 with higher scores reflecting better levels of functioning. This outcome measure shows results for 'physical function domain'.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=188 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=89 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Physical Function Domain (5-items) Score Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT)
|
16.8 Score on a scale
Standard Deviation 20.4
|
8.3 Score on a scale
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Number of participants who achieved ≥14.6 in IWQOL-Lite-CT PFD score (Yes/No) from baseline to end of treatment (week 64) is presented. IWQOL-Lite-CT is a 20-item obesity-specific PRO measures used to assess the impact of body weight changes on patient's physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial functioning (13 items) in 3 composite scores (Physical Function, Physical and Psychosocial) and a Total score, all ranging from 0 to 100 with higher scores reflecting better levels of functioning.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=188 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=89 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Number of Participants Who Achieved ≥14.6 IWQOL-Lite-CT Physical Function Domain (PFD) Score (Yes/No)
Yes
|
104 Participants
|
31 Participants
|
|
Number of Participants Who Achieved ≥14.6 IWQOL-Lite-CT Physical Function Domain (PFD) Score (Yes/No)
No
|
84 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in body weight from baseline (week 0) to end of treatment (week 64) is presented.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=192 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=90 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Body Weight - Kilogram (kg)
|
-15.0 kg
Standard Deviation 11.3
|
-2.3 kg
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in BMI from baseline (week 0) to end of treatment (week 64) is presented.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=192 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=90 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Body Mass Index (BMI)
|
-5.3 Kilogram per square meter (kg/m^2)
Standard Deviation 4.0
|
-0.9 Kilogram per square meter (kg/m^2)
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in waist circumference from baseline (week 0) to end of treatment (week 64) is presented.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=191 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=89 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Waist Circumference
|
-12.9 centimeter (cm)
Standard Deviation 12.3
|
-3.1 centimeter (cm)
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in systolic blood pressure from baseline (week 0) to end of treatment (week 64) is presented.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=192 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=90 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
-7 Millimeters of mercury (mmHg)
Standard Deviation 15
|
-5 Millimeters of mercury (mmHg)
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Randomisation (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in diastolic blood pressure from randomisation (week 0) to end of treatment (week 64) is presented.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=192 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=90 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Diastolic Blood Pressure
|
-3 mmHg
Standard Deviation 9
|
-2 mmHg
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in HbA1c from baseline (week 0) to end of treatment (week 64) is presented.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=190 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=86 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
|
-0.3 Percentage of HbA1c
Standard Deviation 0.3
|
-0.0 Percentage of HbA1c
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in total cholesterol (measured in millimoles per liter \[mmol/L\]) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=187 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=87 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Total Cholesterol - Ratio to Baseline
|
0.96 Ratio of total cholesterol
Geometric Coefficient of Variation 15.3
|
0.98 Ratio of total cholesterol
Geometric Coefficient of Variation 16.4
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=182 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=85 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
|
1.04 Ratio of HDL
Geometric Coefficient of Variation 15.8
|
0.99 Ratio of HDL
Geometric Coefficient of Variation 13.7
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=182 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=85 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
|
0.96 Ratio of LDL
Geometric Coefficient of Variation 24.0
|
0.99 Ratio of LDL
Geometric Coefficient of Variation 25.9
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in VLDL cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=186 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=87 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Very Low-Density Lipoproteins (VLDL) Cholesterol - Ratio to Baseline
|
0.80 Ratio of VLDL
Geometric Coefficient of Variation 38.9
|
0.92 Ratio of VLDL
Geometric Coefficient of Variation 36.8
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in triglycerides (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=186 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=87 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Triglycerides - Ratio to Baseline
|
0.80 Ratio of triglycerides
Geometric Coefficient of Variation 39.2
|
0.93 Ratio of triglycerides
Geometric Coefficient of Variation 36.0
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in free fatty acids (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=180 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=84 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Free Fatty Acids - Ratio to Baseline
|
0.86 Ratio of free fatty acids
Geometric Coefficient of Variation 64.2
|
0.95 Ratio of free fatty acids
Geometric Coefficient of Variation 76.6
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in high sensitivity C-Reactive Protein (hsCRP) (milligram per litre \[mg/L\]) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=188 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=87 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
|
0.50 Ratio of hsCRP
Geometric Coefficient of Variation 111.9
|
0.91 Ratio of hsCRP
Geometric Coefficient of Variation 122.8
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in FPG measured in milligrams per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 64) is presented.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=186 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=87 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG)
|
-7.3 mg/dL
Standard Deviation 10.8
|
0.1 mg/dL
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in fasting serum insulin measured in picomoles per liter (pmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=180 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=84 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Fasting Serum Insulin - Ratio to Baseline
|
0.74 Ratio of fasting serum insulin
Standard Deviation 57.9
|
1.03 Ratio of fasting serum insulin
Standard Deviation 62.5
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.
Number of participants with BMI \<30 at the end of treatment (week 64) from baseline (week 0) is presented. The outcome measure is applicable for participants with BMI ≥ 30 at baseline (week 0). In the reported data, 'Yes' infers the number of participants who have achieved BMI less than 30, whereas 'No' infers the number of participants who have not achieved BMI less than 30 at week 64.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=179 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=86 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Number of Participants With Body Mass Index (BMI) Less Than (<) 30 at Week 64 (Yes/no)
Yes
|
77 Participants
|
9 Participants
|
|
Number of Participants With Body Mass Index (BMI) Less Than (<) 30 at Week 64 (Yes/no)
No
|
102 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure and number analyzed = participants evaluable at a specific time point.
Number of participants with change in glycaemic status from baseline (week 0) to the end of treatment (week 64) is presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) \<5.7%; 2) Pre-diabetes: 5.7% \<= HbA1c \< 6.5% 3) Type 2 diabetes: HbA1c \>=6.5%.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=190 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=86 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Number of Participants With Change in Glycaemic Status
Normo-glycaemia (week 0) · Normo-glycaemia (week 64)
|
92 Participants
|
35 Participants
|
|
Number of Participants With Change in Glycaemic Status
Normo-glycaemia (week 0) · Pre-diabetes (week 64)
|
5 Participants
|
11 Participants
|
|
Number of Participants With Change in Glycaemic Status
Normo-glycaemia (week 0) · Diabetes (week 64)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in Glycaemic Status
Pre-diabetes (week 0) · Normo-glycaemia (week 64)
|
64 Participants
|
13 Participants
|
|
Number of Participants With Change in Glycaemic Status
Pre-diabetes (week 0) · Pre-diabetes (week 64)
|
25 Participants
|
26 Participants
|
|
Number of Participants With Change in Glycaemic Status
Pre-diabetes (week 0) · Diabetes (week 64)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change in Glycaemic Status
Diabetes (week 0) · Normo-glycaemia (week 64)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in Glycaemic Status
Diabetes (week 0) · Pre-diabetes (week 64)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Change in Glycaemic Status
Diabetes (week 0) · Diabetes (week 64)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of study (week 71)Population: SAS included all participants randomly assigned to study treatment and who took at least 1 dose of IMP. Participants were analysed according to the treatment they actually received.
Number of treatment emergent adverse events from baseline (week 0) to end of study (week 71) is presented. An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=204 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=102 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs)
|
1239 Events
|
432 Events
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of study (week 71)Population: SAS included all participants randomly assigned to study treatment and who took at least 1 dose of IMP. Participants were analysed according to the treatment they actually received.
Number of treatment emergent serious adverse events from baseline (week 0) to end of study (week 71) is presented. A serious adverse event (SAE) is any untoward medical occurrence that fulfils at least one of following criteria: results in death; is life-threatening; requires inpatient or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is congenital anomaly/birth defect; important medical event.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=204 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=102 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Number of Serious Treatment Emergent Adverse Events
|
17 Events
|
13 Events
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 64)Population: SAS included all participants randomly assigned to study treatment and who took at least 1 dose of IMP. Participants were analysed according to the treatment they actually received. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in pulse from baseline (week 0) to end of treatment (week 64) is presented.
Outcome measures
| Measure |
Oral Semaglutide 25 mg
n=157 Participants
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=70 Participants
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Change in Pulse
|
2 Beats per minute (Beats/min)
Standard Deviation 10
|
1 Beats per minute (Beats/min)
Standard Deviation 9
|
Adverse Events
Oral Semaglutide 25 mg
Serious events: 8 serious events
Other events: 172 other events
Deaths: 0 deaths
Placebo
Serious events: 9 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Semaglutide 25 mg
n=204 participants at risk
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=102 participants at risk
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/204 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/204 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Infections and infestations
COVID-19
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Cardiac disorders
Cardiac aneurysm
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/204 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/204 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Nervous system disorders
Dysarthria
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/204 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Infections and infestations
Furuncle
|
0.00%
0/204 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Nervous system disorders
Headache
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Vascular disorders
Hypertension
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/204 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/204 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.49%
1/204 • Number of events 2 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Nervous system disorders
Memory impairment
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/204 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/204 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/204 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Surgical and medical procedures
Sleeve gastrectomy
|
0.00%
0/204 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/204 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.49%
1/204 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.00%
0/102 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
Other adverse events
| Measure |
Oral Semaglutide 25 mg
n=204 participants at risk
Participants received semaglutide tablets orally once daily in a dose escalation manner, with dose increases every 4 weeks for up to week 12 (3 mg, 7 mg and 14 mg) followed by maintenance dose of 25 mg once daily up to week 64.
|
Placebo
n=102 participants at risk
Participants received placebo matched to semaglutide orally once daily up to week 64.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.4%
13/204 • Number of events 14 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
2.0%
2/102 • Number of events 2 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
6/204 • Number of events 6 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
5.9%
6/102 • Number of events 9 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
6/204 • Number of events 6 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
5.9%
6/102 • Number of events 6 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
15/204 • Number of events 16 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
3.9%
4/102 • Number of events 5 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.8%
18/204 • Number of events 23 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
2.0%
2/102 • Number of events 2 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Infections and infestations
Bronchitis
|
4.4%
9/204 • Number of events 10 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
6.9%
7/102 • Number of events 8 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Infections and infestations
COVID-19
|
20.1%
41/204 • Number of events 45 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
17.6%
18/102 • Number of events 19 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Gastrointestinal disorders
Constipation
|
20.1%
41/204 • Number of events 59 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
9.8%
10/102 • Number of events 11 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.9%
14/204 • Number of events 15 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.6%
36/204 • Number of events 61 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
8.8%
9/102 • Number of events 10 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Nervous system disorders
Dizziness
|
5.4%
11/204 • Number of events 14 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Gastrointestinal disorders
Dyspepsia
|
18.1%
37/204 • Number of events 50 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
8.8%
9/102 • Number of events 11 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Gastrointestinal disorders
Eructation
|
10.3%
21/204 • Number of events 23 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
2.0%
2/102 • Number of events 2 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
General disorders
Fatigue
|
7.4%
15/204 • Number of events 15 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
0.98%
1/102 • Number of events 1 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.8%
16/204 • Number of events 17 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
4.9%
5/102 • Number of events 5 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Nervous system disorders
Headache
|
11.8%
24/204 • Number of events 34 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
8.8%
9/102 • Number of events 10 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Infections and infestations
Influenza
|
7.4%
15/204 • Number of events 21 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
9.8%
10/102 • Number of events 10 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Infections and infestations
Nasopharyngitis
|
21.1%
43/204 • Number of events 59 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
26.5%
27/102 • Number of events 40 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Gastrointestinal disorders
Nausea
|
46.6%
95/204 • Number of events 157 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
18.6%
19/102 • Number of events 27 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Infections and infestations
Sinusitis
|
3.4%
7/204 • Number of events 8 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
6.9%
7/102 • Number of events 8 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Infections and infestations
Tonsillitis
|
2.5%
5/204 • Number of events 5 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
5.9%
6/102 • Number of events 7 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
11/204 • Number of events 11 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
8.8%
9/102 • Number of events 13 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Infections and infestations
Urinary tract infection
|
6.4%
13/204 • Number of events 16 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
2.9%
3/102 • Number of events 4 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
|
Gastrointestinal disorders
Vomiting
|
30.9%
63/204 • Number of events 105 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
5.9%
6/102 • Number of events 6 • From week 0 to week 71
All presented adverse events (AEs) are treatment emergent adverse events defined as an event with onset during on-treatment observation period. SAS included all participants randomly assigned to study treatment and who took at least 1 dose of trial product. Adverse events were assessed based on safety analysis set and all-cause mortality was assessed for all participants randomized in this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER