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

Eli Lilly and Company210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

210

Conditions

Obesity Overweight Metabolism and Nutrition Disorder

Interventions

TirzepatideDRUG

Administered SC

PlaceboDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (29)

Outcomes

Primary Outcomes

Mean Percent Change From Baseline in Body Weight

Mean Percent Change from Baseline in Body Weight. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + Sex + Presence of Comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Percentage of Participants who Achieve ≥5% Body Weight Reduction. A logistic regression model was used for this analysis.

Time frame: Week 52

Secondary Outcomes

Mean Change From Baseline in Body Weight

Mean Change from Baseline in Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 20

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Percentage of Participants who Achieve ≥10% Body Weight Reduction. A logistic regression model was used for this analysis.

Time frame: Week 52

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Percentage of Participants who Achieve ≥15% Body Weight Reduction. A logistic regression model was used for this analysis.

Time frame: Week 52

Mean Change From Baseline in Waist Circumference

Mean Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital Chongqing Medical University

Chongqing, Chongqing Municipality, China

Zhujiang Hospital

Guangzhou, Guangdong, China

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

The First Hospital of Qinhuangdao

Qinhuangdao, Hebei, China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang, Henan, China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The First Affiliated Hospital of Nanhua University

Hengyang, Hunan, China

Changzhou No.2 People's Hospital

Changzhou, Jiangsu, China

...and 19 more locations

Mean Change From Baseline in Absolute Body Weight

Mean Change from Baseline in Absolute Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Mean Change From Baseline in Body Mass Index (BMI)

Mean Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Mean Change From Baseline in Hemoglobin A1c (HbA1c)

Mean Change from Baseline in HbA1c. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Mean Change From Baseline in Fasting Glucose (FSG)

Mean Change from Baseline in FSG. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Mean Change From Baseline 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: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are 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 and/or better health. Range cannot be specified in norm-based scores. LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Mean Change From Baseline 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. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)

LS mean was determined using MMRM model with Variable = Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)

LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Mean Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

LS mean was determined using MMRM model using log (Actual measurement/Baseline) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Mean Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Mean Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Mean Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)

LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Mean Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)

LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Mean Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 10 mg and 15 mg)

LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52

Mean Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 10 mg and 15 mg)

LS mean was determined using MMRM model with log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame: Baseline, Week 52