A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Tirzepatide Monotherapy Compared With Placebo in Chinese Participants With Type 2 Diabetes
2 other identifiers
interventional
206
1 country
28
Brief Summary
The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy in Chinese participants with Type 2 Diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes
Started Aug 2023
Shorter than P25 for phase_3 type-2-diabetes
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedStudy Start
First participant enrolled
August 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2024
CompletedResults Posted
Study results publicly available
October 21, 2025
CompletedOctober 21, 2025
October 1, 2025
1.1 years
July 19, 2023
October 7, 2025
October 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Treatment (Type III sum of squares) as variables.
Baseline, Week 40
Secondary Outcomes (9)
Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])
Week 40
Change From Baseline in Fasting Serum Glucose
Baseline, Week 40
Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)
Week 40
Change From Baseline in Body Weight
Baseline, Week 40
Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)
Week 40
- +4 more secondary outcomes
Study Arms (4)
5 Milligram (mg) Tirzepatide
EXPERIMENTALParticipants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
10 mg Tirzepatide
EXPERIMENTALParticipants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
15 mg Tirzepatide
EXPERIMENTALParticipants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
Placebo
PLACEBO COMPARATORParticipants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- Have Type 2 Diabetes
- Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol) despite diet and exercise treatment
- Are of stable weight 5%) during the 90 days preceding screening and agree not to initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment
- Have Body Mass Index (BMI) ≥23.0 kilogram per square meter (kg/m²)
You may not qualify if:
- Have Type 1 Diabetes
- Have a history of chronic or acute pancreatitis any time prior to study entry
- Are currently receiving treatment for diabetic retinopathy and/or macular edema
- Have a history of ketoacidosis or hyperosmolar state/coma
- Have a history of New York Heart Association Functional Classification IV congestive heart failure (CHF)
- Have acute or chronic hepatitis including a history of autoimmune hepatitis
- Use of insulin 1-year preceding screening and between screening and baseline; use of any antihyperglycemic medication 90 days preceding screening and between screening and baseline.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Shunde Hospital of Southern Medical Univesity
Foshan, Guangdong, 528399, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, 516001, China
Zunyi First People's Hospital
Zunyi, Guizhou, 563002, China
Hainan General Hospital
Haikou, Hainan, 570311, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, 471003, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473007, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014, China
Yichang Central People's Hospital
Yichang, Hubei, 443003, China
The First People's Hospital of Changde City
Changde, Hunan, 415003, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Nanjing First Hospital
Nanjing, Jiangsu, 210012, China
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211100, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000, China
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
Dalian University - The Affiliated Zhongshan Hospital
Dalian, Liaoning, 116001, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, 116033, China
Panjin Liaoyou Baoshihua Hospital
Liaoyou, Liaoning, 124009, China
The First Affiliated Hospital of Xi'an Medical University
Xi'an, Shaanxi, 710077, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Pudong New Area People's Hospital Shanghai
Shanghai, Shanghai Municipality, 201200, China
Jiading District Central Hospital
Shanghai, Shanghai Municipality, 201800, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Huzhou Central Hospital
Huzhou, Zhejiang, 313000, China
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
July 19, 2023
First Posted
July 27, 2023
Study Start
August 21, 2023
Primary Completion
October 9, 2024
Study Completion
October 9, 2024
Last Updated
October 21, 2025
Results First Posted
October 21, 2025
Record last verified: 2025-10
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.