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

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese PLA General HospitalRecruiting
  • Shunde Hospital of Southern Medical UnivesityRecruiting
  • Huizhou Municipal Central HospitalRecruiting
  • Zunyi First People's HospitalRecruiting
  • Hainan General Hospital
  • The Fourth Hospital of Harbin Medical UniversityRecruiting
  • The First Affiliated Hospital of Henan University of Science &TechnologyRecruiting
  • The First Affiliated Hospital of Nanyang Medical CollegeRecruiting
  • The Second Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Yichang Central People's HospitalRecruiting
  • The First People's Hospital of Changde City
  • Changzhou No.2 People's HospitalRecruiting
  • Nanjing First HospitalRecruiting
  • The Second Affiliated Hospital of Nanjing Medical UniversityRecruiting
  • Nanjing Medical University - Nanjing Jiangning HospitalRecruiting
  • The First Affiliated Hospital of Soochow UniversityRecruiting
  • Affiliated Hospital of Jiangsu UniversityRecruiting
  • Jiangxi Pingxiang People's HospitalRecruiting
  • Dalian University - The Affiliated Zhongshan HospitalRecruiting
  • Dalian Municipal Central Hospital Affiliated of Dalian Medical UniversityRecruiting
  • Panjin Liaoyou Baoshihua Hospital
  • The First Affiliated Hospital of Xi'an Medical UniversityRecruiting
  • Jinan Central HospitalRecruiting
  • Pudong New Area People's Hospital ShanghaiRecruiting
  • Jiading District Central HospitalRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • Chengdu Fifth People's HospitalRecruiting
  • Tianjin Medical University General HospitalRecruiting
  • Huzhou Central HospitalRecruiting
  • Ningbo First Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Tirzepatide Dose 1

Tirzepatide Dose 2

Tirzepatide Dose 3

Placebo

Arm Description

Participants will receive tirzepatide subcutaneously (SC).

Participants will receive tirzepatide SC.

Participants will receive tirzepatide SC.

Participants will receive placebo.

Outcomes

Primary Outcome Measures

Change from Baseline in Hemoglobin A1c (HbA1c)

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2023
Last Updated
October 18, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05963022
Brief Title
A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2023 (Actual)
Primary Completion Date
April 14, 2025 (Anticipated)
Study Completion Date
April 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tirzepatide Dose 1
Arm Type
Experimental
Arm Description
Participants will receive tirzepatide subcutaneously (SC).
Arm Title
Tirzepatide Dose 2
Arm Type
Experimental
Arm Description
Participants will receive tirzepatide SC.
Arm Title
Tirzepatide Dose 3
Arm Type
Experimental
Arm Description
Participants will receive tirzepatide SC.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame
Baseline, Week 40
Secondary Outcome Measure Information:
Title
Percentage of Participants with HbA1c Target Values of <7.0% (<53 mmol/mol)
Time Frame
Week 40
Title
Change from Baseline in Fasting Serum Glucose
Time Frame
Baseline, Week 40
Title
Percentage of Participants with HbA1c Target Values of ≤6.5% (≤48 mmol/mol)
Time Frame
Week 40
Title
Change from Baseline in Body Weight
Time Frame
Baseline, Week 40
Title
Percentage of Participants with HbA1c Target Values of <5.7% (<39 mmol/mol)
Time Frame
Week 40
Title
Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
Time Frame
Baseline, Week 40
Title
Percentage of Participants Who Achieved Weight loss of ≥5%
Time Frame
Week 40
Title
Percentage of Participants Who Achieved Weight loss of ≥10%
Time Frame
Week 40
Title
Percentage of Participants Who Achieved Weight loss of ≥15%
Time Frame
Week 40

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiming Mu
Facility Name
Shunde Hospital of Southern Medical Univesity
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528399
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongqian LIANG
Facility Name
Huizhou Municipal Central Hospital
City
Huizhou
State/Province
Guangdong
ZIP/Postal Code
516001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu Li
Facility Name
Zunyi First People's Hospital
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengyan Jiang
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaining Chen
Facility Name
The Fourth Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZhiFeng Cheng
Facility Name
The First Affiliated Hospital of Henan University of Science &Technology
City
Luoyang Shi
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
13653880139
First Name & Middle Initial & Last Name & Degree
hongwei Jiang
Facility Name
The First Affiliated Hospital of Nanyang Medical College
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473007
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
13837739967
First Name & Middle Initial & Last Name & Degree
Dexue Liu
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450014
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
15838123695
First Name & Middle Initial & Last Name & Degree
Qingju Li
Facility Name
Yichang Central People's Hospital
City
Yichang
State/Province
Hubei
ZIP/Postal Code
443003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaoyang Zeng
Facility Name
The First People's Hospital of Changde City
City
Changde
State/Province
Hunan
ZIP/Postal Code
415003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wen ouyang
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Xue
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Ma
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
18951762690
First Name & Middle Initial & Last Name & Degree
Yibing Lu
Facility Name
Nanjing Medical University - Nanjing Jiangning Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
211100
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
02552105625
First Name & Middle Initial & Last Name & Degree
Kun Wang
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bimin Shi
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoyue Yuan
Facility Name
Jiangxi Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337055
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yawei Zhang
Facility Name
Dalian University - The Affiliated Zhongshan Hospital
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
13940839879
First Name & Middle Initial & Last Name & Degree
Wei Duan
Facility Name
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116033
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
041184412001
First Name & Middle Initial & Last Name & Degree
Xinyu Li
Facility Name
Panjin Liaoyou Baoshihua Hospital
City
Liaoyou
State/Province
Liaoning
ZIP/Postal Code
124009
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Zhang
Facility Name
The First Affiliated Hospital of Xi'an Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710077
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ya Li
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
15318816218
First Name & Middle Initial & Last Name & Degree
Xiaolin Dong
Facility Name
Pudong New Area People's Hospital Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozhen JIANG
Facility Name
Jiading District Central Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201800
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lixia Suo
Facility Name
West China Hospital of Sichuan University
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
18980601658
First Name & Middle Initial & Last Name & Degree
zhenmei an
Facility Name
Chengdu Fifth People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
611130
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
8613730683979
First Name & Middle Initial & Last Name & Degree
Hongyi Cao
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
18322017516
First Name & Middle Initial & Last Name & Degree
Ming Liu
Facility Name
Huzhou Central Hospital
City
Huzhou
State/Province
Zhejiang
ZIP/Postal Code
313000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianping Yao
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
13780008400
First Name & Middle Initial & Last Name & Degree
Jialin Li

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://vivli.org/

Learn more about this trial

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

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