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)
2 other identifiers
interventional
210
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 obesity
Started Sep 2021
Shorter than P25 for phase_3 obesity
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2022
CompletedResults Posted
Study results publicly available
January 19, 2024
CompletedJanuary 19, 2024
December 1, 2023
1.3 years
August 25, 2021
December 26, 2023
December 26, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (19)
Mean Change From Baseline in Body Weight
Baseline, Week 20
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Week 52
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Week 52
Mean Change From Baseline in Waist Circumference
Baseline, Week 52
Mean Change From Baseline in Absolute Body Weight
Baseline, Week 52
- +14 more secondary outcomes
Study Arms (3)
10 Milligrams (mg) Tirzepatide
EXPERIMENTALParticipants 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).
15 mg Tirzepatide
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants received matching placebo SC QW.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102202, China
The First Affiliated Hospital Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Zhujiang Hospital
Guangzhou, Guangdong, 510280, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518039, China
The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471003, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014, China
The First Affiliated Hospital of Nanhua University
Hengyang, Hunan, 421001, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213000, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211100, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Siping Central People's Hospital
Siping, Jilin, 136000, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Huadong Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200071, China
Qingpu Branch of Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 201700, China
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, 710077, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006, China
Huzhou Central Hospital
Huzhou, Zhejiang, 313000, China
Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
The Fifth People's Hospital of Shanghai
Shanghai, 200240, China
Shanghai Minhang District Central Hospital
Shanghai, 201199, China
Related Publications (1)
Zhao L, Cheng Z, Lu Y, Liu M, Chen H, Zhang M, Wang R, Yuan Y, Li X. Tirzepatide for Weight Reduction in Chinese Adults With Obesity: The SURMOUNT-CN Randomized Clinical Trial. JAMA. 2024 Aug 20;332(7):551-560. doi: 10.1001/jama.2024.9217.
PMID: 38819983DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2021
First Posted
August 27, 2021
Study Start
September 1, 2021
Primary Completion
December 27, 2022
Study Completion
December 27, 2022
Last Updated
January 19, 2024
Results First Posted
January 19, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.