Trial Outcomes & Findings for A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America (NCT NCT05579249)
NCT ID: NCT05579249
Last Updated: 2026-01-14
Results Overview
Number of participants who achieved greater than or equal to 10.0% body weight reduction (yes/no) at week 52 is presented.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
500 participants
Primary outcome timeframe
At end of treatment (week 52)
Results posted on
2026-01-14
Participant Flow
The study was conducted at one site in United States.
Participant milestones
| Measure |
Semaglutide 2.4 mg
Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.
|
Other Anti-obesity Medications (AOMs)
Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
|
|---|---|---|
|
Overall Study
STARTED
|
250
|
250
|
|
Overall Study
Full Analysis Set
|
250
|
250
|
|
Overall Study
Safety Analysis Set
|
242
|
242
|
|
Overall Study
COMPLETED
|
214
|
191
|
|
Overall Study
NOT COMPLETED
|
36
|
59
|
Reasons for withdrawal
| Measure |
Semaglutide 2.4 mg
Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.
|
Other Anti-obesity Medications (AOMs)
Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
33
|
52
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Death
|
0
|
2
|
Baseline Characteristics
A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America
Baseline characteristics by cohort
| Measure |
Semaglutide 2.4 mg
n=250 Participants
Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.
|
Other Anti-obesity Medications (AOMs)
n=250 Participants
Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.6 Years
STANDARD_DEVIATION 9.3 • n=14 Participants
|
42.0 Years
STANDARD_DEVIATION 10.3 • n=10 Participants
|
41.3 Years
STANDARD_DEVIATION 9.8 • n=24 Participants
|
|
Sex: Female, Male
Female
|
225 Participants
n=14 Participants
|
223 Participants
n=10 Participants
|
448 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=14 Participants
|
27 Participants
n=10 Participants
|
52 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
159 Participants
n=14 Participants
|
150 Participants
n=10 Participants
|
309 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=14 Participants
|
100 Participants
n=10 Participants
|
191 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=14 Participants
|
8 Participants
n=10 Participants
|
18 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=14 Participants
|
7 Participants
n=10 Participants
|
24 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=14 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=14 Participants
|
27 Participants
n=10 Participants
|
50 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
193 Participants
n=14 Participants
|
202 Participants
n=10 Participants
|
395 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=14 Participants
|
5 Participants
n=10 Participants
|
7 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: At end of treatment (week 52)Population: Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Number of participants who achieved greater than or equal to 10.0% body weight reduction (yes/no) at week 52 is presented.
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=207 Participants
Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.
|
Other Anti-obesity Medications (AOMs)
n=177 Participants
Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
|
|---|---|---|
|
Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no)
Yes
|
132 Participants
|
61 Participants
|
|
Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no)
No
|
75 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 52)Population: Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Percentage change in body weight from week 0 to week 52 is presented.
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=207 Participants
Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.
|
Other Anti-obesity Medications (AOMs)
n=177 Participants
Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
|
|---|---|---|
|
Percentage Change in Body Weight
|
-13.6 Percentange change in body weight
Standard Deviation 8.7
|
-7.4 Percentange change in body weight
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 52)Population: Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. This outcome measure shows results for physical function domain.
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=189 Participants
Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.
|
Other Anti-obesity Medications (AOMs)
n=163 Participants
Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
|
|---|---|---|
|
Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain
|
25.6 Score on a scale
Standard Deviation 21.2
|
22.6 Score on a scale
Standard Deviation 24.4
|
SECONDARY outcome
Timeframe: At end of treatment (week 52)Population: Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Number of participants who achieved more than or equal to 15.0% body weight reduction (yes/no) at week 52 is presented.
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=207 Participants
Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.
|
Other Anti-obesity Medications (AOMs)
n=177 Participants
Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
|
|---|---|---|
|
Number of Participants Who Achieved Greater Than or Equal to (≥) 15.0% Body Weight Reduction (Yes/no)
Yes
|
93 Participants
|
25 Participants
|
|
Number of Participants Who Achieved Greater Than or Equal to (≥) 15.0% Body Weight Reduction (Yes/no)
No
|
114 Participants
|
152 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (week 52)Population: Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Number of participants who achieved more than or equal to 20.0% body weight reduction (yes/no) at week 52 is presented.
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=207 Participants
Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.
|
Other Anti-obesity Medications (AOMs)
n=177 Participants
Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
|
|---|---|---|
|
Number of Participants Who Achieved Greater Than or Equal to (≥) 20.0% Body Weight Reduction (Yes/no)
Yes
|
49 Participants
|
8 Participants
|
|
Number of Participants Who Achieved Greater Than or Equal to (≥) 20.0% Body Weight Reduction (Yes/no)
No
|
158 Participants
|
169 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (week 52)Population: Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. This outcome measure shows results for physical function domain score ≥ 14.6.
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=189 Participants
Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.
|
Other Anti-obesity Medications (AOMs)
n=163 Participants
Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
|
|---|---|---|
|
Number of Participants Who Achieved Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain Score Greater Than or Equal to (≥) 14.6 (Yes/no)
Yes
|
138 Participants
|
108 Participants
|
|
Number of Participants Who Achieved Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain Score Greater Than or Equal to (≥) 14.6 (Yes/no)
No
|
51 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: From week 0 to week 52Population: Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
Percentage of days covered by study product from week 0 to week 52 is presented. The percentage of days covered by the study product is determined by the duration on the study product divided by the planned study duration, multiplied by 100.
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=242 Participants
Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.
|
Other Anti-obesity Medications (AOMs)
n=242 Participants
Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
|
|---|---|---|
|
Percentage of Days Covered (PDC) by Study Product
|
83.7 Percentage of days covered
Standard Deviation 24.6
|
70.8 Percentage of days covered
Standard Deviation 28.6
|
SECONDARY outcome
Timeframe: At end of treatment (week 52)Population: Full analysis set included all randomized participants.
Number of participants covered by study product ≥80% of days (yes/no) from week 0 to week 52 is presented.
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=250 Participants
Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.
|
Other Anti-obesity Medications (AOMs)
n=250 Participants
Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
|
|---|---|---|
|
Number of Participants Covered by Study Product Greater Than or Equal to (≥) 80% of Days (Yes/no)
Yes
|
168 Participants
|
113 Participants
|
|
Number of Participants Covered by Study Product Greater Than or Equal to (≥) 80% of Days (Yes/no)
No
|
82 Participants
|
137 Participants
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 52)Population: Full analysis set included all randomized participants Overall number of participants analyzed = participants with available data for this outcome measure.
Work Limitations Questionnaire (WLQ-25) is a 25-item questionnaire that measures how health problems affect job performance and productivity over the past two weeks, using a 5-point Likert scale. It covers four domains: Time Management (5 items), Physical Demands (6), Mental/Interpersonal (9), and Output Demands (5). Each item is scored from 1 to 5, with subscale scores calculated as the average item score, then converted to a 0-100 scale using the formula: WLQ Scale Score= 25 × (average item score - 1). Thus, each subscale ranges from 0 (no limitation) to 100 (maximum limitation). The WLQ total score is computed by applying specific weights to each subscale and summing them: 0.00048 × Time scale + 0.00036 × Physical scale + 0.00096 × Mental/Interpersonal scale + 0.00106 × Output scale. This total is then transformed into the proportion of productivity loss using the formula: (1 - exp(-total score)).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=186 Participants
Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.
|
Other Anti-obesity Medications (AOMs)
n=159 Participants
Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
|
|---|---|---|
|
Change in Work Limitations Questionnaire 25-item Version (WLQ-25), Total Score (TS)
|
-0.034 Score on a scale
Standard Deviation 0.070
|
-0.016 Score on a scale
Standard Deviation 0.048
|
Adverse Events
Semaglutide 2.4 mg
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Other Anti-obesity Medications (AOMs)
Serious events: 8 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Semaglutide 2.4 mg
n=242 participants at risk
Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.
|
Other Anti-obesity Medications (AOMs)
n=242 participants at risk
Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
|
|---|---|---|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.41%
1/242 • Number of events 1 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
0.00%
0/242 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.41%
1/242 • Number of events 1 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
0.00%
0/242 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/242 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
0.83%
2/242 • Number of events 2 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/242 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
0.41%
1/242 • Number of events 1 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.41%
1/242 • Number of events 1 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
0.83%
2/242 • Number of events 2 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/242 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
0.41%
1/242 • Number of events 1 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/242 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
0.41%
1/242 • Number of events 1 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/242 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
0.41%
1/242 • Number of events 1 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/242 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
|
0.41%
1/242 • Number of events 1 • From week 0 to week 52
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all participants who are exposed to study intervention. AEs were assessed in SAS and All-Cause Mortality was assessed for all enrolled participants.
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Other adverse events
Adverse event data not reported
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