A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)

March 6, 2024 updated by: Eli Lilly and Company

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, 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 Hospital of Harbin Medical University
    • Henan
      • Luoyang Shi, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Nanyang, Henan, China
        • 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, 210006
        • Nanjing First Hospital
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Nanjing, Jiangsu, China, 211100
        • Nanjing Medical University - Nanjing Jiangning 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
      • Shanghai, Shanghai, China, 201200
        • Pudong New Area People's Hospital Shanghai
      • Shanghai, Shanghai, China, 201800
        • Jiading District Central Hospital
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • West China Hospital of Sichuan University
      • Chengdu, Sichuan, China, 611130
        • Chengdu Fifth People's Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital
    • Zhejiang
      • Huzhou, Zhejiang, China, 313000
        • Huzhou Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo.
Drug: Placebo
Administered SC
Experimental: Tirzepatide Dose 1
Participants will receive tirzepatide subcutaneously (SC).
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Experimental: Tirzepatide Dose 2
Participants will receive tirzepatide SC.
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Experimental: Tirzepatide Dose 3
Participants will receive tirzepatide SC.
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 40
Baseline, Week 40

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with HbA1c Target Values of <7.0% (<53 mmol/mol)
Time Frame: Week 40
Week 40
Change from Baseline in Fasting Serum Glucose
Time Frame: Baseline, Week 40
Baseline, Week 40
Percentage of Participants with HbA1c Target Values of ≤6.5% (≤48 mmol/mol)
Time Frame: Week 40
Week 40
Change from Baseline in Body Weight
Time Frame: Baseline, Week 40
Baseline, Week 40
Percentage of Participants with HbA1c Target Values of <5.7% (<39 mmol/mol)
Time Frame: Week 40
Week 40
Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
Time Frame: Baseline, Week 40
Baseline, Week 40
Percentage of Participants Who Achieved Weight loss of ≥5%
Time Frame: Week 40
Week 40
Percentage of Participants Who Achieved Weight loss of ≥10%
Time Frame: Week 40
Week 40
Percentage of Participants Who Achieved Weight loss of ≥15%
Time Frame: Week 40
Week 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2023

Primary Completion (Estimated)

September 24, 2024

Study Completion (Estimated)

September 24, 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 (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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