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

The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy in Chinese participants with Type 2 Diabetes.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Tirzepatide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100853
      • Chinese PLA General Hospital
  • Guangdong
    • Foshan, Guangdong, China, 528399
      • Shunde Hospital of Southern Medical Univesity
    • Huizhou, Guangdong, China, 516001
      • Huizhou Municipal Central Hospital
  • Guizhou
    • Zunyi, Guizhou, China, 563002
      • Zunyi First People's Hospital
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The Fourth Affiliated Hospital of Harbin Medical University
  • Henan
    • Luoyang Shi, Henan, China, 471003
      • The First Affiliated Hospital of Henan University of Science &Technology
    • Nanyang, Henan, China, 473007
      • The First Affiliated Hospital of Nanyang Medical College
    • Zhengzhou, Henan, China, 450014
      • The Second Affiliated Hospital of Zhengzhou University
  • Hubei
    • Yichang, Hubei, China, 443003
      • Yichang Central People's Hospital
  • Hunan
    • Changde, Hunan, China, 415003
      • The First People's Hospital of Changde City
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 211100
      • Nanjing Medical University - Nanjing Jiangning Hospital
    • Nanjing, Jiangsu, China, 210012
      • Nanjing First Hospital
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University
    • Zhenjiang, Jiangsu, China, 212000
      • Affiliated Hospital of Jiangsu University
  • Jiangxi
    • Pingxiang, Jiangxi, China, 337055
      • Jiangxi Pingxiang People's Hospital
  • Liaoning
    • Dalian, Liaoning, China, 116033
      • Dalian Municipal Central Hospital Affiliated of Dalian Medical University
    • Dalian, Liaoning, China, 116001
      • Dalian University - The Affiliated Zhongshan Hospital
    • Liaoyou, Liaoning, China, 124009
      • Panjin Liaoyou Baoshihua Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710077
      • The First Affiliated Hospital of Xi'an Medical University
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201800
      • Jiading District Central Hospital
    • Shanghai, Shanghai Municipality, China, 201200
      • Pudong New Area People's Hospital Shanghai
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
    • Chengdu, Sichuan, China, 611130
      • Chengdu Fifth People's Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital
  • Zhejiang
    • Huzhou, Zhejiang, China, 313000
      • Huzhou Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 mg Tirzepatide; Participants 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.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Experimental: 15 mg Tirzepatide; Participants 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.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Placebo Comparator: Placebo; Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.	Drug: Placebo; Administered SC
Experimental: 5 Milligram (mg) Tirzepatide; Participants 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.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Weight Loss of ≥5%	Percentage of Participants who Achieved Weight Loss ≥5% is reported here.	Week 40
Percentage of Participants Who Achieved Weight Loss of ≥10%	Percentage of Participants who Achieved Weight Loss ≥10% is reported here.	Week 40
Percentage of Participants Who Achieved Weight Loss of ≥15%	Percentage of Participants who Achieved Weight Loss ≥15% is reported here.	Week 40
Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [mmol/Mol])	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c <7.0% (<53 mmol/mol) is reported here.	Week 40
Change From Baseline in Fasting Serum Glucose	LS mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares) as variables.	Baseline, Week 40
Percentage of Participants With HbA1c Target Values of ≤6.5% (≤48 mmol/Mol)	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c ≤6.5% (≤48 mmol/Mol) is reported here.	Week 40
Change From Baseline in Body Weight	LS mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares) as variables.	Baseline, Week 40
Percentage of Participants With HbA1c Target Values of <5.7% (<39 mmol/Mol)	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of participants with HbA1c <5.7% (<39 mmol/mol) is reported here.	Week 40
Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)	The SMBG data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS Mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + Baseline HbA1c (<=8.5%, >8.5%) + Prior Antihyperglycemic Use + Treatment + Time + Treatment*Time(Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.	Baseline, Week 40

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): August 21, 2023
• Primary Completion (Actual): October 9, 2024
• Study Completion (Actual): October 9, 2024

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Estimated): October 21, 2025
• Last Update Submitted That Met QC Criteria: October 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide
• Other Study ID Numbers: 18746; I8F-MC-GPIU (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