Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program (NCT NCT04657016)

Last Updated: 2024-05-16

Results Overview

Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

579 participants

Primary outcome timeframe

Baseline, 72 Weeks

Results posted on

2024-05-16

Participant Flow

There was a 12-week lead-in period wherein the participants underwent intensive lifestyle modification program to reduce their daily caloric energy intake and increase their physical activity, followed by which they were randomized to receive Tirzepatide or Placebo.

Participant milestones

Participant milestones
Measure	Placebo Participants received matching placebo subcutaneously (SC) once weekly (QW).	Tirzepatide Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.
Overall Study STARTED	292	287
Overall Study Received at Least One Dose of Study Drug	292	287
Overall Study COMPLETED	227	252
Overall Study NOT COMPLETED	65	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received matching placebo subcutaneously (SC) once weekly (QW).	Tirzepatide Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.
Overall Study Adverse Event	2	4
Overall Study Death	1	1
Overall Study Lost to Follow-up	24	12
Overall Study Physician Decision	1	2
Overall Study Pregnancy	2	2
Overall Study Protocol Deviation	1	0
Overall Study Withdrawal by Subject	28	14
Overall Study Other - as reported by the investigator	6	0

Baseline Characteristics

A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=292 Participants Participants received matching placebo SC QW.	Tirzepatide n=287 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.	Total n=579 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=39 Participants	4 Participants n=41 Participants	6 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=39 Participants	2 Participants n=41 Participants	6 Participants n=35 Participants
Race (NIH/OMB) Asian	2 Participants n=39 Participants	2 Participants n=41 Participants	4 Participants n=35 Participants
Age, Continuous	45.70 years STANDARD_DEVIATION 11.79 • n=39 Participants	45.40 years STANDARD_DEVIATION 12.59 • n=41 Participants	45.60 years STANDARD_DEVIATION 12.18 • n=35 Participants
Sex: Female, Male Female	183 Participants n=39 Participants	181 Participants n=41 Participants	364 Participants n=35 Participants
Sex: Female, Male Male	109 Participants n=39 Participants	106 Participants n=41 Participants	215 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	161 Participants n=39 Participants	151 Participants n=41 Participants	312 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	129 Participants n=39 Participants	132 Participants n=41 Participants	261 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	32 Participants n=39 Participants	31 Participants n=41 Participants	63 Participants n=35 Participants
Race (NIH/OMB) White	252 Participants n=39 Participants	246 Participants n=41 Participants	498 Participants n=35 Participants
Race (NIH/OMB) More than one race	2 Participants n=39 Participants	6 Participants n=41 Participants	8 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment Argentina	44 Participants n=39 Participants	43 Participants n=41 Participants	87 Participants n=35 Participants
Region of Enrollment Brazil	60 Participants n=39 Participants	59 Participants n=41 Participants	119 Participants n=35 Participants
Region of Enrollment United States	188 Participants n=39 Participants	185 Participants n=41 Participants	373 Participants n=35 Participants
Body weight	101.29 Kilograms (kg) STANDARD_DEVIATION 20.67 • n=39 Participants	102.47 Kilograms (kg) STANDARD_DEVIATION 22.11 • n=41 Participants	101.87 Kilograms (kg) STANDARD_DEVIATION 21.39 • n=35 Participants

PRIMARY outcome

Timeframe: Baseline, 72 Weeks

Population: All randomly assigned participants who took at least 1 dose of study drug, had a baseline and at least 1 post- baseline value for this outcome, excluding data after discontinuation of study drug.

Outcome measures

Outcome measures
Measure	Placebo n=291 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=284 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Percent Change From Baseline in Body Weight	3.3 Percent change Standard Error 0.60	-21.1 Percent change Standard Error 0.59

PRIMARY outcome

Timeframe: Week 72

Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression model using imputed data with baseline body weight, Analysis Country, Sex, Treatment as factors.

Outcome measures

Outcome measures
Measure	Placebo n=291 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=284 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction	10.65 percentage of participants	94.37 percentage of participants

SECONDARY outcome

Timeframe: 72 Weeks

Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

Outcome measures

Outcome measures
Measure	Placebo n=291 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=284 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program	37.80 percentage of participants	98.59 percentage of participants

SECONDARY outcome

Timeframe: 72 Weeks

Percentage of participants who achieve ≥10% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

Outcome measures

Outcome measures
Measure	Placebo n=291 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=284 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Percentage of Participants Who Achieve ≥10%Body Weight Reduction	4.81 percentage of participants	88.03 percentage of participants

SECONDARY outcome

Timeframe: 72 Weeks

Percentage of participants who achieve ≥15% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

Outcome measures

Outcome measures
Measure	Placebo n=291 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=284 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Percentage of Participants Who Achieve ≥15% Body Weight Reduction	2.06 Percentage of participants	73.94 Percentage of participants

SECONDARY outcome

Timeframe: 72 Weeks

Percentage of participants who achieve ≥20% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.

Outcome measures

Outcome measures
Measure	Placebo n=291 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=284 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Percentage of Participants Who Achieve ≥20% Body Weight Reduction	1.03 Percentage of participants	54.93 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

Change from baseline in waist circumference. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	Placebo n=291 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=284 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Change From Baseline in Waist Circumference	1.1 Centimeters (Cms) Standard Error 0.58	-16.8 Centimeters (Cms) Standard Error 0.56

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

Change from baseline in body weight. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	Placebo n=291 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=284 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Change From Baseline in Body Weight	3.5 kg Standard Error 0.67	-21.5 kg Standard Error 0.65

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

Change from baseline in BMI. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	Placebo n=291 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=284 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Change From Baseline in Body Mass Index (BMI)	1.2 kilogram per meter square (kg/m^2) Standard Error 0.23	-7.7 kilogram per meter square (kg/m^2) Standard Error 0.23

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

Change from baseline in SBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	Placebo n=291 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=284 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Change From Baseline in Systolic Blood Pressure (SBP)	4.4 millimeters of mercury (mmHg) Standard Error 0.76	-5.8 millimeters of mercury (mmHg) Standard Error 0.73

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

Change from baseline in DBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	Placebo n=291 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=284 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Change From Baseline in Diastolic Blood Pressure (DBP)	2.3 mmHg Standard Error 0.53	-3.4 mmHg Standard Error 0.51

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

Percent change from baseline in total cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	Placebo n=252 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=263 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Percent Change From Baseline in Total Cholesterol	5.19 Percent change Standard Error 1.11	-3.00 Percent change Standard Error 0.97

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

Percent change from baseline in HDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	Placebo n=252 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=263 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol	3.6 Percent change Standard Error 1.12	15.4 Percent change Standard Error 1.19

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

Percent change from baseline in LDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	Placebo n=252 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=263 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol	6.14 Percent change Standard Error 1.71	-6.07 Percent change Standard Error 1.44

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

Percent change from baseline in VLDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	Placebo n=252 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=261 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol	3.0 Percent change Standard Error 2.32	-25.6 Percent change Standard Error 1.60

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

Percent change from baseline in triglycerides. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	Placebo n=252 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=263 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Percent Change From Baseline in Triglycerides	3.0 Percent change Standard Error 2.34	-25.8 Percent change Standard Error 1.61

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

Percent change from baseline in free fatty acids. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	Placebo n=251 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=263 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Percent Change From Baseline in Free Fatty Acids	-15.0 Percent change Standard Error 2.95	-33.1 Percent change Standard Error 2.20

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

Change from baseline in fasting glucose. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	Placebo n=276 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=275 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Change From Baseline in Fasting Glucose	2.4 Milligram per deciliter (mg/dL) Standard Error 0.86	-8.8 Milligram per deciliter (mg/dL) Standard Error 0.82

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	Placebo n=275 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=278 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Change From Baseline in Hemoglobin A1c (HbA1c)	0.01 Percentage of HbA1c Standard Deviation 0.022	-0.46 Percentage of HbA1c Standard Deviation 0.020

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

Percent change from baseline in fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	Placebo n=275 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=277 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Percent Change From Baseline in Fasting Insulin	17.3 Percent change Standard Error 4.95	-39.1 Percent change Standard Error 2.46

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores. LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.

Outcome measures

Outcome measures
Measure	Placebo n=209 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=231 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Change From Baseline in Short Form 36 Version 2 Health Survey Version 2 (SF 36v2) Acute Form Physical Functioning Domain Score	-0.6 T-score Standard Error 0.39	3.3 T-score Standard Error 0.37

SECONDARY outcome

Timeframe: Baseline, 72 Weeks

The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related 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 health-related quality of life. LS mean was determined using ANCOVA model with Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.

Outcome measures

Outcome measures
Measure	Placebo n=201 Participants Participants received matching placebo SC once weekly QW.	Tirzepatide n=226 Participants Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Change From Baseline in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score	1.1 score on a scale Standard Error 1.17	13.9 score on a scale Standard Error 1.10

Adverse Events

Placebo

Serious events: 14 serious events

Other events: 172 other events

Deaths: 1 deaths

Tirzepatide

Serious events: 17 serious events

Other events: 230 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 08005455979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Placebo n=292 participants at risk Participants received matching placebo SC once weekly QW.	Tirzepatide n=287 participants at risk Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Cardiac disorders Acute myocardial infarction	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Cardiac disorders Myocardial infarction	0.34% 1/292 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.00% 0/287 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Abdominal pain	0.34% 1/292 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.00% 0/287 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Colitis microscopic	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Haematochezia	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Impaired gastric emptying	0.34% 1/292 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.00% 0/287 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Pancreatitis	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Pancreatitis acute	0.34% 1/292 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.00% 0/287 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Small intestinal obstruction	0.34% 1/292 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Umbilical hernia	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
General disorders Pyrexia	0.34% 1/292 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.00% 0/287 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Infections and infestations Appendicitis	0.34% 1/292 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.00% 0/287 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Infections and infestations Cellulitis	0.34% 1/292 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Infections and infestations Pneumonia	0.34% 1/292 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.00% 0/287 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Infections and infestations Pyelonephritis	0.34% 1/292 • Number of events 2 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.00% 0/287 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Infections and infestations Sepsis	0.34% 1/292 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Infections and infestations Toxoplasmosis	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Infections and infestations Urinary tract infection	0.34% 1/292 • Number of events 3 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.00% 0/287 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Injury, poisoning and procedural complications Limb injury	0.34% 1/292 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.00% 0/287 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.34% 1/292 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.00% 0/287 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Pregnancy, puerperium and perinatal conditions Anembryonic gestation	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Renal and urinary disorders Acute kidney injury	0.00% 0/292 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.35% 1/287 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Renal and urinary disorders Nephrolithiasis	1.0% 3/292 • Number of events 3 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.00% 0/287 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Respiratory, thoracic and mediastinal disorders Asthma	0.34% 1/292 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.00% 0/287 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.34% 1/292 • Number of events 1 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	0.00% 0/287 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.

Measure	Placebo n=292 participants at risk Participants received matching placebo SC once weekly QW.	Tirzepatide n=287 participants at risk Participants received weekly doses of tirzepatide SC for 72 weeks, starting at 2.5 mg for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the MTD of either 10 mg or 15 mg.
Gastrointestinal disorders Abdominal pain	2.4% 7/292 • Number of events 10 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	10.5% 30/287 • Number of events 38 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Constipation	6.8% 20/292 • Number of events 24 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	23.0% 66/287 • Number of events 89 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Diarrhoea	9.2% 27/292 • Number of events 53 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	31.0% 89/287 • Number of events 233 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Dyspepsia	3.1% 9/292 • Number of events 10 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	9.4% 27/287 • Number of events 47 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Eructation	1.0% 3/292 • Number of events 3 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	5.6% 16/287 • Number of events 26 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Flatulence	2.7% 8/292 • Number of events 8 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	6.6% 19/287 • Number of events 24 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.4% 7/292 • Number of events 9 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	6.6% 19/287 • Number of events 44 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Nausea	14.0% 41/292 • Number of events 112 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	39.7% 114/287 • Number of events 499 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gastrointestinal disorders Vomiting	1.4% 4/292 • Number of events 4 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	18.1% 52/287 • Number of events 133 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
General disorders Fatigue	3.1% 9/292 • Number of events 9 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	7.0% 20/287 • Number of events 23 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
General disorders Injection site reaction	1.0% 3/292 • Number of events 3 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	11.1% 32/287 • Number of events 204 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Infections and infestations Covid-19	25.3% 74/292 • Number of events 80 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	23.0% 66/287 • Number of events 69 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Infections and infestations Influenza	8.6% 25/292 • Number of events 30 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	4.2% 12/287 • Number of events 13 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Infections and infestations Sinusitis	5.5% 16/292 • Number of events 18 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	2.1% 6/287 • Number of events 6 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Infections and infestations Upper respiratory tract infection	7.2% 21/292 • Number of events 32 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	8.7% 25/287 • Number of events 37 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Metabolism and nutrition disorders Decreased appetite	4.1% 12/292 • Number of events 13 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	9.4% 27/287 • Number of events 33 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Musculoskeletal and connective tissue disorders Arthralgia	5.1% 15/292 • Number of events 16 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	2.4% 7/287 • Number of events 8 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Musculoskeletal and connective tissue disorders Back pain	5.1% 15/292 • Number of events 16 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	5.9% 17/287 • Number of events 19 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Nervous system disorders Dizziness	2.1% 6/292 • Number of events 6 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	7.0% 20/287 • Number of events 24 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Nervous system disorders Headache	7.5% 22/292 • Number of events 27 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	9.4% 27/287 • Number of events 37 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Psychiatric disorders Anxiety	6.5% 19/292 • Number of events 19 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	3.1% 9/287 • Number of events 9 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Skin and subcutaneous tissue disorders Alopecia	1.4% 4/292 • Number of events 6 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.	7.0% 20/287 • Number of events 20 • Baseline up to week 76 All randomized participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.