Trial Outcomes & Findings for A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range (NCT NCT06041217)
NCT ID: NCT06041217
Last Updated: 2026-05-18
Results Overview
Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 44) 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
242 participants
Primary outcome timeframe
At end of treatment (week 44)
Results posted on
2026-05-18
Participant Flow
The trial was conducted at 19 sites across mainland China and Taiwan.
Participants were randomised in 2:1 ratio to receive once weekly subcutaneous (s.c.) injection of either semaglutide 2.4 mg or semaglutide matching placebo as an adjunct to a reduced-calorie diet and increased physical activity. The trial has a 44-week treatment period (16 weeks of dose escalation period and 28 weeks of maintenance period), followed by a 5-week follow-up period.
Participant milestones
| Measure |
Semaglutide 2.4 mg
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Placebo
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Overall Study
STARTED
|
161
|
81
|
|
Overall Study
Full Analysis Set
|
161
|
81
|
|
Overall Study
Safety Analysis Set
|
161
|
81
|
|
Overall Study
COMPLETED
|
161
|
79
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Semaglutide 2.4 mg
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Placebo
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range
Baseline characteristics by cohort
| Measure |
Semaglutide 2.4 mg
n=161 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Placebo
n=81 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 Years
STANDARD_DEVIATION 10 • n=11 Participants
|
41 Years
STANDARD_DEVIATION 12 • n=9 Participants
|
41 Years
STANDARD_DEVIATION 11 • n=20 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=11 Participants
|
42 Participants
n=9 Participants
|
121 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=11 Participants
|
39 Participants
n=9 Participants
|
121 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
161 Participants
n=11 Participants
|
81 Participants
n=9 Participants
|
242 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
161 Participants
n=11 Participants
|
81 Participants
n=9 Participants
|
242 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. 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 44) is presented.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=159 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Body Weight (%)
|
-2.2 Percentage change in body weight
Standard Deviation 5.4
|
-12.2 Percentage change in body weight
Standard Deviation 8.2
|
PRIMARY outcome
Timeframe: At end of treatment (week 44)Population: FAS included all randomised participants. 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 44) 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 |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=159 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)
Yes
|
19 Participants
|
128 Participants
|
|
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)
No
|
59 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (week 44)Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Number of participants who achieved ≥10% body weight reduction at the end of treatment (week 44) 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 |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=159 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)
Yes
|
9 Participants
|
96 Participants
|
|
Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)
No
|
69 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. 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 44) is presented.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=159 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Waist Circumference
|
-2.4 Centimeter (cm)
Standard Deviation 5.0
|
-9.1 Centimeter (cm)
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in body weight in kilogram (kg) from baseline (week 0) to end of treatment (week 44) is presented.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=159 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Body Weight (kg)
|
-1.7 Kg
Standard Deviation 4.3
|
-9.3 Kg
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in body mass index from baseline (week 0) to end of treatment (week 44) is presented.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=159 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Body Mass Index
|
-0.6 Kilogram per square meter (kg/m^2)
Standard Deviation 1.5
|
-3.4 Kilogram per square meter (kg/m^2)
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in waist-height ratio (WtHR) from baseline (week 0) to end of treatment (week 44) is presented.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=159 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Waist-height Ratio (WtHR)
|
-0.01 Ratio of waist-height
Standard Deviation 0.03
|
-0.05 Ratio of waist-height
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. 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 44) is presented.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=159 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
-4 Millimeter of mercury (mmHg)
Standard Deviation 10
|
-7 Millimeter of mercury (mmHg)
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=159 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Diastolic Blood Pressure
|
-2 mmHg
Standard Deviation 8
|
-4 mmHg
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. 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 44) is presented as ratio to baseline.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=158 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Total Cholesterol (mmol/L) - Ratio to Baseline
|
1.01 Ratio of total cholesterol
Geometric Coefficient of Variation 13.1
|
0.94 Ratio of total cholesterol
Geometric Coefficient of Variation 16.5
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. 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 44) is presented as ratio to baseline.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=158 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
|
1.06 Ratio of HDL
Geometric Coefficient of Variation 13.7
|
1.04 Ratio of HDL
Geometric Coefficient of Variation 13.8
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. 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 44) is presented as ratio to baseline.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=156 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
|
1.02 Ratio of LDL
Geometric Coefficient of Variation 24.1
|
0.97 Ratio of LDL
Geometric Coefficient of Variation 24.4
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. 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 44) is presented as ratio to baseline.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=156 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Very Low-Density Lipoproteins (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
|
0.93 Ratio of VLDL
Geometric Coefficient of Variation 38.8
|
0.72 Ratio of VLDL
Geometric Coefficient of Variation 44.2
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. 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 44) is presented as ratio to baseline.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=156 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Triglycerides (mmol/L) - Ratio to Baseline
|
0.91 Ratio of triglycerides
Geometric Coefficient of Variation 44.5
|
0.71 Ratio of triglycerides
Geometric Coefficient of Variation 46.5
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. 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 44) is presented as ratio to baseline.
Outcome measures
| Measure |
Placebo
n=77 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=157 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Free Fatty Acids (mmol/L) - Ratio to Baseline
|
0.99 Ratio of free fatty acids
Geometric Coefficient of Variation 61.5
|
0.88 Ratio of free fatty acids
Geometric Coefficient of Variation 60.2
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in high sensitivity C-Reactive Protein (hsCRP) measured in milligram per litre (mg/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=158 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
|
0.68 Ratio of hsCRP
Geometric Coefficient of Variation 118.2
|
0.69 Ratio of hsCRP
Geometric Coefficient of Variation 154.3
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in glycosylated haemoglobin (HbA1c) in percentage from baseline (week 0) to end of treatment (week 44) is presented.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=158 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in HbA1c (%)
|
0.0 Percentage of HbA1c
Standard Deviation 0.3
|
-0.4 Percentage of HbA1c
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in HbA1c measured in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=158 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in HbA1c (mmol/Mol)
|
0.5 mmol/mol
Standard Deviation 3.6
|
-4.2 mmol/mol
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in fasting plasma glucose (FPG) measured in milligrams per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) is presented.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=158 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (mg/dL)
|
0.5 mg/dL
Standard Deviation 14.5
|
-12.3 mg/dL
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Change in FPG measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented.
Outcome measures
| Measure |
Placebo
n=78 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=158 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (mmol/L)
|
0.0 mmol/L
Standard Deviation 0.8
|
-0.7 mmol/L
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of study (week 49)Population: Safety analysis set (SAS) included all participants who were exposed to at least one dose of randomised IMP. Overall number of participants analyzed = participants with available data for this outcome measure.
Number of TEAEs from baseline (week 0) to end of study (week 49) is presented. An adverse event is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP.
Outcome measures
| Measure |
Placebo
n=81 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=161 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs)
|
183 Events
|
614 Events
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of study (week 49)Population: SAS included all participants who were exposed to at least one dose of randomised IMP. Overall number of participants analyzed = participants with available data for this outcome measure.
Number of SAEs from baseline (week 0) to end of study (week 49) 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 |
Placebo
n=81 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=161 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Number of Serious Adverse Events (SAEs)
|
3 Events
|
14 Events
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: SAS included all participants who were exposed to at least one dose of randomised IMP. 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 44) is presented.
Outcome measures
| Measure |
Placebo
n=74 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=152 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Pulse
|
1 Beats per minute (Beats/min)
Standard Deviation 9
|
3 Beats per minute (Beats/min)
Standard Deviation 11
|
SECONDARY outcome
Timeframe: From baseline (week 0) to end of study (week 49)Population: SAS included all participants who were exposed to at least one dose of randomised IMP. Overall number of participants analyzed = participants with available data for this outcome measure.
Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L) confirmed by BG meter for participants with T2D from baseline (week 0) to end of study (week 49) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than 3.0 mmol/L (54 mg/dL) confirmed by BG meter.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Semaglutide 2.4 mg
n=31 Participants
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner. The dose was increased every 4 weeks up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) Less Than (<) 3.0 mmol/L Confirmed by Blood Glucose (BG) Meter - Participants With Type 2 Diabetes (T2D)
|
0 Episodes
|
1 Episodes
|
Adverse Events
Sema 2.4 mg
Serious events: 13 serious events
Other events: 113 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sema 2.4 mg
n=161 participants at risk
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner, with dose increasing every 4 weeks for up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Placebo
n=81 participants at risk
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.62%
1/161 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/161 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
1.2%
1/81 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.62%
1/161 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.62%
1/161 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.62%
1/161 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.62%
1/161 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.62%
1/161 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.62%
1/161 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Injury, poisoning and procedural complications
Open globe injury
|
0.62%
1/161 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.62%
1/161 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/161 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
1.2%
1/81 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Infections and infestations
Perirectal abscess
|
0.62%
1/161 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/161 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
1.2%
1/81 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.62%
1/161 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.62%
1/161 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.62%
1/161 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Ear and labyrinth disorders
Vertigo
|
0.62%
1/161 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
Other adverse events
| Measure |
Sema 2.4 mg
n=161 participants at risk
Participants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner, with dose increasing every 4 weeks for up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
Placebo
n=81 participants at risk
Participants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
8.1%
13/161 • Number of events 13 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
1.2%
1/81 • Number of events 1 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.6%
9/161 • Number of events 9 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
4.9%
4/81 • Number of events 4 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Gastrointestinal disorders
Constipation
|
13.7%
22/161 • Number of events 25 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
3.7%
3/81 • Number of events 3 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.3%
31/161 • Number of events 34 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
2.5%
2/81 • Number of events 2 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.6%
30/161 • Number of events 43 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
7.4%
6/81 • Number of events 6 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Nervous system disorders
Dizziness
|
8.1%
13/161 • Number of events 15 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
2.5%
2/81 • Number of events 2 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.1%
13/161 • Number of events 15 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Infections and infestations
Nasopharyngitis
|
9.9%
16/161 • Number of events 18 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
2.5%
2/81 • Number of events 4 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Gastrointestinal disorders
Nausea
|
18.0%
29/161 • Number of events 37 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
2.5%
2/81 • Number of events 2 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.4%
28/161 • Number of events 34 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
14.8%
12/81 • Number of events 17 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
|
Gastrointestinal disorders
Vomiting
|
9.9%
16/161 • Number of events 24 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
0.00%
0/81 • From baseline (week 0) to end of study (week 49)
An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of an IMP. Adverse events were assessed based on SAS that included all participants who were exposed to at least one dose of randomised IMP.
|
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