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

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)

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 Overview

• Status: Completed
• Conditions: Obesity; Overweight; Metabolism and Nutrition Disorder
• Intervention / Treatment: Drug: Tirzepatide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200240
    • The Fifth People's Hospital of Shanghai
  • Shanghai, China, 201199
    • Shanghai Minhang District Central Hospital
  • Beijing
    • Beijing, Beijing, China, 102202
      • Beijing Tsinghua Changgung Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • The First Affiliated Hospital Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital
    • Shenzhen, Guangdong, China, 518039
      • Shenzhen Second People's Hospital
  • Hebei
    • Qinhuangdao, Hebei, China, 066000
      • The First Hospital of Qinhuangdao
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The Fourth Affiliated Hospital of Harbin Medical University
  • Henan
    • Luoyang, Henan, China, 471003
      • The First Affiliated Hospital of Henan University of Science &Technology
    • Zhengzhou, Henan, China, 450014
      • The Second Affiliated Hospital of Zhengzhou University
  • Hunan
    • Hengyang, Hunan, China, 421001
      • The First Affiliated Hospital of Nanhua University
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • Changzhou No.2 People's Hospital
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 211100
      • Nanjing Medical University - Nanjing Jiangning Hospital
    • Nantong, Jiangsu, China, 226001
      • Affiliated Hospital of Nantong University
    • Wuxi, Jiangsu, China, 214023
      • Wuxi People's Hospital
  • Jilin
    • Changchun, Jilin, China
      • The Second Hospital of Jilin University
    • Siping, Jilin, China, 136000
      • Siping Central People's Hospital
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital, Fudan University
    • Shanghai, Shanghai, China, 200071
      • Shanghai Hospital of Traditional Chinese Medicine
    • Shanghai, Shanghai, China, 200040
      • Huadong Hospital Affiliated to Fudan University
    • Shanghai, Shanghai, China, 201700
      • Qingpu Branch of Zhongshan Hospital, Fudan University
  • Shanxi
    • Xi'an, Shanxi, China, 710077
      • The First Affiliated Hospital of Xi'an Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • The First People's Hospital of Hangzhou
    • Huzhou, Zhejiang, China, 313000
      • Huzhou Central Hospital
    • Ningbo, Zhejiang, China, 315010
      • Ningbo First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 Milligrams (mg) Tirzepatide; Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW).	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Experimental: 15 mg Tirzepatide; Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Placebo Comparator: Placebo; Participants received matching placebo SC QW.	Drug: Placebo; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): December 27, 2022
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Body Weight; Obesity; Overweight; Nutrition Disorders; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Tirzepatide
• Other Study ID Numbers: 17507; I8F-MC-GPIA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes