Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities (NCT NCT05822830)
NCT ID: NCT05822830
Last Updated: 2025-11-26
Results Overview
Percent change from baseline in body weight was reported. Least Squares (LS) mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
751 participants
Primary outcome timeframe
Baseline, Week 72
Results posted on
2025-11-26
Participant Flow
Participant milestones
| Measure |
15 mg or MTD - Tirzepatide
Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or maximum tolerated dose \[MTD (10 mg or 15 mg)\] until Week 72.
|
2.4 mg or MTD - Semaglutide
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
|
|---|---|---|
|
Overall Study
STARTED
|
375
|
376
|
|
Overall Study
Received At Least One Dose of Study Drug
|
374
|
376
|
|
Overall Study
COMPLETED
|
319
|
319
|
|
Overall Study
NOT COMPLETED
|
56
|
57
|
Reasons for withdrawal
| Measure |
15 mg or MTD - Tirzepatide
Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or maximum tolerated dose \[MTD (10 mg or 15 mg)\] until Week 72.
|
2.4 mg or MTD - Semaglutide
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
6
|
|
Overall Study
Assigned Treatment by Mistake
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
16
|
18
|
|
Overall Study
Non-Compliance With Study Drug
|
1
|
1
|
|
Overall Study
Participant was Out of the Country
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
27
|
26
|
Baseline Characteristics
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities
Baseline characteristics by cohort
| Measure |
15 mg or MTD - Tirzepatide
n=374 Participants
Participants received a starting dose of 2.5 mg tirzepatide administered SC QW for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or MTD (10 mg or 15 mg) until Week 72.
|
2.4 mg or MTD - Semaglutide
n=376 Participants
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
|
Total
n=750 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.00 years
STANDARD_DEVIATION 12.94 • n=9 Participants
|
44.40 years
STANDARD_DEVIATION 12.74 • n=32 Participants
|
44.70 years
STANDARD_DEVIATION 12.84 • n=18 Participants
|
|
Sex: Female, Male
Female
|
242 Participants
n=9 Participants
|
243 Participants
n=32 Participants
|
485 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=9 Participants
|
133 Participants
n=32 Participants
|
265 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
93 Participants
n=9 Participants
|
103 Participants
n=32 Participants
|
196 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
281 Participants
n=9 Participants
|
273 Participants
n=32 Participants
|
554 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
6 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=9 Participants
|
7 Participants
n=32 Participants
|
18 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
77 Participants
n=9 Participants
|
67 Participants
n=32 Participants
|
144 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
276 Participants
n=9 Participants
|
295 Participants
n=32 Participants
|
571 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=9 Participants
|
7 Participants
n=32 Participants
|
11 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
374 Participants
n=9 Participants
|
376 Participants
n=32 Participants
|
750 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 72Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Percent change from baseline in body weight was reported. Least Squares (LS) mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables.
Outcome measures
| Measure |
15 mg or MTD - Tirzepatide
n=318 Participants
Participants received a starting dose of 2.5 mg tirzepatide administered SC QW for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or MTD (10 mg or 15 mg) until Week 72.
|
2.4 mg or MTD - Semaglutide
n=318 Participants
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
|
|---|---|---|
|
Percent Change From Baseline in Body Weight
|
-20.2 Percent change
Standard Error 0.59
|
-13.7 Percent change
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Week 72Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Percentage of participants who achieved ≥10% body weight reduction (observed values) was reported.
Outcome measures
| Measure |
15 mg or MTD - Tirzepatide
n=318 Participants
Participants received a starting dose of 2.5 mg tirzepatide administered SC QW for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or MTD (10 mg or 15 mg) until Week 72.
|
2.4 mg or MTD - Semaglutide
n=318 Participants
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
|
|---|---|---|
|
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
|
87.7 Percentage of participants
|
66.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Percentage of participants who achieved ≥15% body weight reduction (observed values) was reported.
Outcome measures
| Measure |
15 mg or MTD - Tirzepatide
n=318 Participants
Participants received a starting dose of 2.5 mg tirzepatide administered SC QW for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or MTD (10 mg or 15 mg) until Week 72.
|
2.4 mg or MTD - Semaglutide
n=318 Participants
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
|
|---|---|---|
|
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
|
71.7 Percentage of participants
|
45.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Percentage of participants who achieved ≥20% body weight reduction (observed values) was reported.
Outcome measures
| Measure |
15 mg or MTD - Tirzepatide
n=318 Participants
Participants received a starting dose of 2.5 mg tirzepatide administered SC QW for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or MTD (10 mg or 15 mg) until Week 72.
|
2.4 mg or MTD - Semaglutide
n=318 Participants
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
|
|---|---|---|
|
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
|
55.0 Percentage of participants
|
31.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Percentage of participants who achieved ≥25% body weight reduction (observed values) was reported.
Outcome measures
| Measure |
15 mg or MTD - Tirzepatide
n=318 Participants
Participants received a starting dose of 2.5 mg tirzepatide administered SC QW for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or MTD (10 mg or 15 mg) until Week 72.
|
2.4 mg or MTD - Semaglutide
n=318 Participants
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
|
|---|---|---|
|
Percentage of Participants Who Achieve ≥25% Body Weight Reduction
|
36.5 Percentage of participants
|
18.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Change from baseline in waist circumference in centimeter was reported. LS mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables.
Outcome measures
| Measure |
15 mg or MTD - Tirzepatide
n=318 Participants
Participants received a starting dose of 2.5 mg tirzepatide administered SC QW for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or MTD (10 mg or 15 mg) until Week 72.
|
2.4 mg or MTD - Semaglutide
n=318 Participants
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
|
|---|---|---|
|
Change From Baseline in Waist Circumference in Centimeter
|
-18.4 centimeters
Standard Error 0.61
|
-13.0 centimeters
Standard Error 0.66
|
SECONDARY outcome
Timeframe: Week 72Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Percentage of participants who achieved ≥30% body weight reduction (observed values) was reported.
Outcome measures
| Measure |
15 mg or MTD - Tirzepatide
n=318 Participants
Participants received a starting dose of 2.5 mg tirzepatide administered SC QW for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or MTD (10 mg or 15 mg) until Week 72.
|
2.4 mg or MTD - Semaglutide
n=318 Participants
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
|
|---|---|---|
|
Percentage of Participants Who Achieve ≥30% Body Weight Reduction
|
23.0 Percentage of participants
|
8.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Change from baseline in BMI was reported. LS mean was determined using Mixed Model Repeated Measures (MMRM) model using Baseline + Sex + Pre diabetes status at randomization + Treatment + Time + Treatment\*Time(Type III sum of squares) as variables.
Outcome measures
| Measure |
15 mg or MTD - Tirzepatide
n=367 Participants
Participants received a starting dose of 2.5 mg tirzepatide administered SC QW for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or MTD (10 mg or 15 mg) until Week 72.
|
2.4 mg or MTD - Semaglutide
n=373 Participants
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
|
|---|---|---|
|
Change From Baseline in Body Mass Index (BMI)
|
-8.5 kilograms per meter square
Standard Error 0.24
|
-6.0 kilograms per meter square
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
Percent change from baseline in body weight comparing 15mg of Tirzepatide and 2.4 mg Semaglutide was reported. The treatment effect for tirzepatide versus semaglutide for percent change in body weight was also evaluated assuming that participants had stayed on treatment and reached the highest dose of treatment. LS mean was determined by MMRM model using Baseline + Sex + Pre diabetes status at randomization + Baseline BMI Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
15 mg or MTD - Tirzepatide
n=367 Participants
Participants received a starting dose of 2.5 mg tirzepatide administered SC QW for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or MTD (10 mg or 15 mg) until Week 72.
|
2.4 mg or MTD - Semaglutide
n=373 Participants
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
|
|---|---|---|
|
Percent Change From Baseline in Body Weight Comparing 15 mg Tirzepatide and 2.4 mg Semaglutide
|
-21.8 Percent change
Standard Error 0.60
|
-15.4 Percent change
Standard Error 0.60
|
Adverse Events
15 mg or MTD - Tirzepatide
Serious events: 18 serious events
Other events: 255 other events
Deaths: 0 deaths
2.4 mg or MTD - Semaglutide
Serious events: 13 serious events
Other events: 267 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
15 mg or MTD - Tirzepatide
n=374 participants at risk
Participants received a starting dose of 2.5 mg tirzepatide administered SC QW for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or MTD (10 mg or 15 mg) until Week 72.
|
2.4 mg or MTD - Semaglutide
n=376 participants at risk
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Cardiac disorders
Sinus tachycardia
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/374 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.27%
1/376 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/374 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.27%
1/376 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/374 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.27%
1/376 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Incarcerated hiatus hernia
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/374 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.27%
1/376 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Volvulus
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/374 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.53%
2/376 • Number of events 2 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.53%
2/374 • Number of events 2 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.80%
3/376 • Number of events 3 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/374 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.27%
1/376 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Infections and infestations
Appendicitis
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.27%
1/376 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Infections and infestations
Pneumonia
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.27%
1/376 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Infections and infestations
Sinusitis
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Investigations
Hepatic enzyme increased
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.53%
2/374 • Number of events 2 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/242 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.41%
1/243 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Nervous system disorders
Benign fasciculation syndrome
|
0.00%
0/374 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.27%
1/376 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Nervous system disorders
Syncope
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Nervous system disorders
Transient global amnesia
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/374 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.27%
1/376 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.27%
1/374 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.00%
0/376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/374 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.27%
1/376 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
Other adverse events
| Measure |
15 mg or MTD - Tirzepatide
n=374 participants at risk
Participants received a starting dose of 2.5 mg tirzepatide administered SC QW for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or MTD (10 mg or 15 mg) until Week 72.
|
2.4 mg or MTD - Semaglutide
n=376 participants at risk
Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
7.2%
27/374 • Number of events 50 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
6.4%
24/376 • Number of events 29 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
24/374 • Number of events 31 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
6.9%
26/376 • Number of events 29 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Constipation
|
27.0%
101/374 • Number of events 179 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
28.5%
107/376 • Number of events 167 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.5%
88/374 • Number of events 227 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
23.4%
88/376 • Number of events 212 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
22/374 • Number of events 31 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
7.4%
28/376 • Number of events 40 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Eructation
|
9.9%
37/374 • Number of events 47 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
7.7%
29/376 • Number of events 37 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.1%
23/374 • Number of events 34 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
10.6%
40/376 • Number of events 59 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Nausea
|
43.6%
163/374 • Number of events 561 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
44.4%
167/376 • Number of events 505 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
56/374 • Number of events 154 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
21.3%
80/376 • Number of events 218 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
General disorders
Fatigue
|
10.4%
39/374 • Number of events 108 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
12.2%
46/376 • Number of events 72 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
General disorders
Injection site reaction
|
8.6%
32/374 • Number of events 376 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
0.27%
1/376 • Number of events 1 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Infections and infestations
Covid-19
|
13.6%
51/374 • Number of events 54 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
12.5%
47/376 • Number of events 48 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
17/374 • Number of events 20 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
6.1%
23/376 • Number of events 28 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Infections and infestations
Sinusitis
|
2.9%
11/374 • Number of events 14 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
5.6%
21/376 • Number of events 23 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.6%
32/374 • Number of events 36 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
11.4%
43/376 • Number of events 49 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.5%
17/374 • Number of events 17 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
5.1%
19/376 • Number of events 20 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Nervous system disorders
Dizziness
|
6.4%
24/374 • Number of events 30 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
4.8%
18/376 • Number of events 21 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Nervous system disorders
Headache
|
7.2%
27/374 • Number of events 43 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
7.2%
27/376 • Number of events 44 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
31/374 • Number of events 31 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
6.1%
23/376 • Number of events 23 • Baseline Up To 72 Weeks
All randomized participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatment regimen received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60