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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05963022
Collaborator
(none)
200
Enrollment
30
Locations
4
Arms
20
Anticipated Duration (Months)
6.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Sep 5, 2023
Anticipated Primary Completion Date :
May 5, 2025
Anticipated Study Completion Date :
May 5, 2025

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    Placebo Comparator: Placebo

    Participants will receive placebo.

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 40]

    Secondary Outcome Measures

    1. Percentage of Participants with HbA1c Target Values of <7.0% (<53 mmol/mol) [Week 40]

    2. Change from Baseline in Fasting Serum Glucose [Baseline, Week 40]

    3. Percentage of Participants with HbA1c Target Values of ≤6.5% (≤48 mmol/mol) [Week 40]

    4. Change from Baseline in Body Weight [Baseline, Week 40]

    5. Percentage of Participants with HbA1c Target Values of <5.7% (<39 mmol/mol) [Week 40]

    6. Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG) [Baseline, Week 40]

    7. Percentage of Participants Who Achieved Weight loss of ≥5% [Week 40]

    8. Percentage of Participants Who Achieved Weight loss of ≥10% [Week 40]

    9. Percentage of Participants Who Achieved Weight loss of ≥15% [Week 40]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese PLA General Hospital Beijing Beijing China 100853
    2 Shunde Hospital of Southern Medical Univesity Foshan Guangdong China 528399
    3 Huizhou Municipal Central Hospital Huizhou Guangdong China 516001
    4 Zunyi First People's Hospital Zunyi Guizhou China 563002
    5 Hainan General Hospital Haikou Hainan China 570311
    6 The Fourth Hospital of Harbin Medical University Harbin Heilongjiang China 150001
    7 The First Affiliated Hospital of Henan University of Science &Technology Luoyang Henan China 471003
    8 The First Affiliated Hospital of Nanyang Medical College Nanyang Henan China
    9 The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450014
    10 Yichang Central People's Hospital Yichang Hubei China 443003
    11 The First People's Hospital of Changde City Changde Hunan China 415003
    12 Changzhou No.2 People's Hospital Changzhou Jiangsu China 213000
    13 Nanjing First Hospital Nanjing Jiangsu China 210006
    14 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210011
    15 Nanjing Medical University - Nanjing Jiangning Hospital Nanjing Jiangsu China 211100
    16 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215006
    17 Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu China 212000
    18 Pingxiang People's Hospital Pingxiang Jiangxi China 337055
    19 Dalian University - The Affiliated Zhongshan Hospital Dalian Liaoning China 116001
    20 Dalian Municipal Central Hospital Affiliated of Dalian Medical University Dalian Liaoning China 116033
    21 Panjin Liaoyou Baoshihua Hospital Liaoyuan Liaoning China 124009
    22 The First Affiliated Hospital of Xi'an Medical University Xi'an Shaanxi China 710077
    23 Jinan Central Hospital Jinan Shandong China 250013
    24 Pudong New Area People's Hospital Shanghai Shanghai Shanghai China 201200
    25 Jiading District Central Hospital Shanghai Shanghai China 201800
    26 West China Hospital of Sichuan University Chengdu Sichuan China 610041
    27 Chengdu Fifth People's Hospital Chengdu Sichuan China 611130
    28 Tianjin Medical University General Hospital Tianjin Tianjin China 300052
    29 Huzhou Central Hospital Huzhou Zhejiang China 313000
    30 Ningbo First Hospital Ningbo Zhejiang China 315010

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05963022
    Other Study ID Numbers:
    • 18746
    • I8F-MC-GPIU
    First Posted:
    Jul 27, 2023
    Last Update Posted:
    Jul 27, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Tirzepatide

    Study Results

    No Results Posted as of Jul 27, 2023