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

Primary Purpose

Obesity, Overweight, Metabolism and Nutrition Disorder

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Beijing Tsinghua Changgung Hospital
  • The First Affiliated Hospital Chongqing Medical University
  • Zhujiang Hospital
  • Shenzhen Second People's Hospital
  • The First Hospital of Qinhuangdao
  • The Fourth Affiliated Hospital of Harbin Medical University
  • The First Affiliated Hospital of Henan University of Science &Technology
  • The Second Affiliated Hospital of Zhengzhou University
  • The First Affiliated Hospital of Nanhua University
  • Changzhou No.2 People's Hospital
  • The Second Affiliated Hospital of Nanjing Medical University
  • Nanjing Medical University - Nanjing Jiangning Hospital
  • Affiliated Hospital of Nantong University
  • Wuxi People's Hospital
  • The Second Hospital of Jilin University
  • Siping Central People's Hospital
  • Jinan Central Hospital
  • Zhongshan Hospital, Fudan University
  • Huadong Hospital Affiliated to Fudan University
  • Shanghai Hospital of Traditional Chinese Medicine
  • Qingpu Branch of Zhongshan Hospital, Fudan University
  • The First Affiliated Hospital of Xi'an Medical University
  • West China Hospital of Sichuan University
  • Tianjin Medical University General Hospital
  • The First People's Hospital of Hangzhou
  • Huzhou Central Hospital
  • Ningbo First Hospital
  • The Fifth People's Hospital of Shanghai
  • Shanghai Minhang District Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Tirzepatide Dose 1

Tirzepatide Dose 2

Placebo

Arm Description

tirzepatide administered subcutaneously (SC) once a week.

tirzepatide administered SC once a week.

placebo administered SC once a week.

Outcomes

Primary Outcome Measures

Mean Percent Change from Randomization in Body Weight
Mean Percent Change from Randomization in Body Weight
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Percentage of Participants who Achieve ≥5% Body Weight Reduction

Secondary Outcome Measures

Mean Change from Randomization in Body Weight
Mean Change from Randomization in Body Weight
Percentage of Participants who Achieve ≥10% Body Weight Reduction
Percentage of Participants who Achieve ≥10% Body Weight Reduction
Percentage of Participants who Achieve ≥15% Body Weight Reduction
Percentage of Participants who Achieve ≥15% Body Weight Reduction
Mean Change from Randomization in Waist Circumference
Mean Change from Randomization in Waist Circumference
Mean Change from Randomization in Body Weight
Mean Change from Randomization in Body Weight
Mean Change from Randomization in Body Mass Index (BMI)
Mean Change from Randomization in BMI
Mean Change from Randomization in Hemoglobin A1c (HbA1c)
Mean Change from Randomization in HbA1c
Mean Change from Randomization in Fasting Glucose (FSG)
Mean Change from Randomization in FSG
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.
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.
Mean Change from Randomization in Diastolic Blood Pressure (DBP)
Mean Change from Randomization in DBP
Mean Change from Randomization in Systolic Blood Pressure (SBP)
Mean Change from Randomization in SBP
Mean Change from Randomization in Total Cholesterol
Mean Change from Randomization in Total Cholesterol
Mean Change from Randomization in High Density Lipoprotein (HDL) Cholesterol
Mean Change from Randomization in HDL Cholesterol
Mean Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol
Mean Change from Randomization in LDL Cholesterol
Mean Change from Randomization in Very Low Density Lipoprotein (VLDL) Cholesterol
Mean Change from Randomization in VLDL Cholesterol
Mean Change from Randomization in Triglycerides
Mean Change from Randomization in Triglycerides
Mean Change from Randomization in Free Fatty Acids
Mean Change from Randomization in Free Fatty Acids
Mean Change from Randomization in Fasting Insulin
Mean Change from Randomization in Fasting Insulin

Full Information

First Posted
August 25, 2021
Last Updated
January 18, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05024032
Brief Title
A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 27, 2022 (Actual)
Study Completion Date
December 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Metabolism and Nutrition Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tirzepatide Dose 1
Arm Type
Experimental
Arm Description
tirzepatide administered subcutaneously (SC) once a week.
Arm Title
Tirzepatide Dose 2
Arm Type
Experimental
Arm Description
tirzepatide administered SC once a week.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo administered SC once a week.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Mean Percent Change from Randomization in Body Weight
Description
Mean Percent Change from Randomization in Body Weight
Time Frame
Randomization, Week 52
Title
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Description
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Mean Change from Randomization in Body Weight
Description
Mean Change from Randomization in Body Weight
Time Frame
Randomization, Week 20
Title
Percentage of Participants who Achieve ≥10% Body Weight Reduction
Description
Percentage of Participants who Achieve ≥10% Body Weight Reduction
Time Frame
Week 52
Title
Percentage of Participants who Achieve ≥15% Body Weight Reduction
Description
Percentage of Participants who Achieve ≥15% Body Weight Reduction
Time Frame
Week 52
Title
Mean Change from Randomization in Waist Circumference
Description
Mean Change from Randomization in Waist Circumference
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in Body Weight
Description
Mean Change from Randomization in Body Weight
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in Body Mass Index (BMI)
Description
Mean Change from Randomization in BMI
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in Hemoglobin A1c (HbA1c)
Description
Mean Change from Randomization in HbA1c
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in Fasting Glucose (FSG)
Description
Mean Change from Randomization in FSG
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Description
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.
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Description
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.
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in Diastolic Blood Pressure (DBP)
Description
Mean Change from Randomization in DBP
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in Systolic Blood Pressure (SBP)
Description
Mean Change from Randomization in SBP
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in Total Cholesterol
Description
Mean Change from Randomization in Total Cholesterol
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in High Density Lipoprotein (HDL) Cholesterol
Description
Mean Change from Randomization in HDL Cholesterol
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in Low Density Lipoprotein (LDL) Cholesterol
Description
Mean Change from Randomization in LDL Cholesterol
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in Very Low Density Lipoprotein (VLDL) Cholesterol
Description
Mean Change from Randomization in VLDL Cholesterol
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in Triglycerides
Description
Mean Change from Randomization in Triglycerides
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in Free Fatty Acids
Description
Mean Change from Randomization in Free Fatty Acids
Time Frame
Randomization, Week 52
Title
Mean Change from Randomization in Fasting Insulin
Description
Mean Change from Randomization in Fasting Insulin
Time Frame
Randomization, Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Tsinghua Changgung Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102202
Country
China
Facility Name
The First Affiliated Hospital Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Zhujiang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518039
Country
China
Facility Name
The First Hospital of Qinhuangdao
City
Qinhuangdao Shi
State/Province
Hebei
ZIP/Postal Code
066000
Country
China
Facility Name
The Fourth Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
The First Affiliated Hospital of Henan University of Science &Technology
City
Luoyang Shi
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450014
Country
China
Facility Name
The First Affiliated Hospital of Nanhua University
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Facility Name
Nanjing Medical University - Nanjing Jiangning Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
211100
Country
China
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Siping Central People's Hospital
City
Siping
State/Province
Jilin
ZIP/Postal Code
136000
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Huadong Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Hospital of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200071
Country
China
Facility Name
Qingpu Branch of Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201700
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Medical University
City
XI 'an
State/Province
Shanxi
ZIP/Postal Code
710077
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
The First People's Hospital of Hangzhou
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Huzhou Central Hospital
City
Huzhou
State/Province
Zhejiang
ZIP/Postal Code
313000
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Facility Name
The Fifth People's Hospital of Shanghai
City
Shanghai
ZIP/Postal Code
200240
Country
China
Facility Name
Shanghai Minhang District Central Hospital
City
Shanghai
ZIP/Postal Code
201199
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://vivli.org/

Learn more about this trial

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

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