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

Obesity Clinical Trial

— SURMOUNT-CN  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05024032
• Other study ID #: 17507
• Secondary ID: I8F-MC-GPIA
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2021
• Est. completion date: December 27, 2022

Study information

• Verified date: December 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 27, 2022
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity
• Overweight

Intervention

Drug:
• Tirzepatide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing
China	The Second Hospital of Jilin University	Changchun	Jilin
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital Chongqing Medical University	Chongqing	Chongqing
China	Zhujiang Hospital	Guangzhou	Guangdong
China	The First People's Hospital of Hangzhou	Hangzhou	Zhejiang
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The First Affiliated Hospital of Nanhua University	Hengyang	Hunan
China	Huzhou Central Hospital	Huzhou	Zhejiang
China	Jinan Central Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang	Henan
China	Nanjing Medical University - Nanjing Jiangning Hospital	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Ningbo First Hospital	Ningbo	Zhejiang
China	The First Hospital of Qinhuangdao	Qinhuangdao	Hebei
China	Huadong Hospital Affiliated to Fudan University	Shanghai	Shanghai
China	Qingpu Branch of Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	Shanghai Hospital of Traditional Chinese Medicine	Shanghai	Shanghai
China	Shanghai Minhang District Central Hospital	Shanghai
China	The Fifth People's Hospital of Shanghai	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong
China	Siping Central People's Hospital	Siping	Jilin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	The First Affiliated Hospital of Xi'an Medical University	Xi'an	Shanxi
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 52
Primary	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.	Week 52
Secondary	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.	Baseline, Week 20
Secondary	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.	Week 52
Secondary	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.	Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52
Secondary	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.	Baseline, Week 52