A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)

Study Overview
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Brief Summary
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This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have obesity or overweight. The main purpose is to learn more about how tirzepatide affects body weight.

Official Title
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Efficacy and Safety of Tirzepatide Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-CN)

Conditions
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Obesity, Overweight, Metabolism and Nutrition Disorder

Intervention / Treatment
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* Drug: Tirzepatide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a BMI ≥28 kilogram/square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease Have a history of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion Criteria: Have Diabetes Mellitus Have a self-reported change in body weight >5 kg within 3 months prior to screening Have obesity induced by other endocrinological disorders Have had a history of chronic or acute pancreatitis Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years Have any lifetime history of a suicide attempt Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirzepatide Dose 1<br>tirzepatide administered subcutaneously (SC) once a week. | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Experimental: Tirzepatide Dose 2<br>tirzepatide administered SC once a week. | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Placebo Comparator: Placebo<br>placebo administered SC once a week. | Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change from Randomization in Body Weight | Mean Percent Change from Randomization in Body Weight | Randomization, Week 52 | 
| Percentage of Participants who Achieve ≥5% Body Weight Reduction | Percentage of Participants who Achieve ≥5% Body Weight Reduction | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Randomization in Body Weight | Mean Change from Randomization in Body Weight | Randomization, Week 20 | 
| Percentage of Participants who Achieve ≥10% Body Weight Reduction | Percentage of Participants who Achieve ≥10% Body Weight Reduction | Week 52 | 
| Percentage of Participants who Achieve ≥15% Body Weight Reduction | Percentage of Participants who Achieve ≥15% Body Weight Reduction | Week 52 | 
| Mean Change from Randomization in Waist Circumference | Mean Change from Randomization in Waist Circumference | Randomization, Week 52 | 
| Mean Change from Randomization in Body Weight | Mean Change from Randomization in Body Weight | Randomization, Week 52 | 
| Mean Change from Randomization in Body Mass Index (BMI) | Mean Change from Randomization in BMI | Randomization, Week 52 | 
| Mean Change from Randomization in Hemoglobin A1c (HbA1c) | Mean Change from Randomization in HbA1c | Randomization, Week 52 | 
| Mean Change from Randomization in Fasting Glucose (FSG) | Mean Change from Randomization in FSG | Randomization, Week 52 | 
| Mean Change from Randomization in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score | The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains; 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning 7) limitations in usual role due to emotional problems; and 8) general mental health. Domain scores are norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10, with higher scores indicating better levels of function and/or better health. | Randomization, Week 52 | 
| Mean Change from Randomization in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score | 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. Individual composite scale scores and a total score can be computed and are presented on a scale of 0 to 100, with higher scores indicating better function. | Randomization, Week 52 | 
| Mean Change from Randomization in Diastolic Blood Pressure (DBP) | Mean Change from Randomization in DBP | Randomization, Week 52 | 
| Mean Change from Randomization in Systolic Blood Pressure (SBP) | Mean Change from Randomization in SBP | Randomization, Week 52 | 
| Mean Change from Randomization in Total Cholesterol | Mean Change from Randomization in Total Cholesterol | Randomization, Week 52 | 
| Mean Change from Randomization in High Density Lipoprotein (HDL) Cholesterol | Mean Change from Randomization in HDL Cholesterol | Randomization, Week 52 | 
| Mean Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol | Mean Change from Randomization in LDL Cholesterol | Randomization, Week 52 | 
| Mean Change from Randomization in Very Low Density Lipoprotein (VLDL) Cholesterol | Mean Change from Randomization in VLDL Cholesterol | Randomization, Week 52 | 
| Mean Change from Randomization in Triglycerides | Mean Change from Randomization in Triglycerides | Randomization, Week 52 | 
| Mean Change from Randomization in Free Fatty Acids | Mean Change from Randomization in Free Fatty Acids | Randomization, Week 52 | 
| Mean Change from Randomization in Fasting Insulin | Mean Change from Randomization in Fasting Insulin | Randomization, Week 52 |