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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05963022
• Other study ID #: 18746
• Secondary ID: I8F-MC-GPIU
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 21, 2023
• Est. completion date: September 24, 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 24, 2024
• Est. primary completion date: September 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Tirzepatide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing
China	The First People's Hospital of Changde City	Changde	Hunan
China	West China Hospital of Sichuan University	Cheng Du	Sichuan
China	Chengdu Fifth People's Hospital	Chengdu	Sichuan
China	Dalian Municipal Central Hospital Affiliated of Dalian Medical University	Dalian	Liaoning
China	Dalian University - The Affiliated Zhongshan Hospital	Dalian	Liaoning
China	Shunde Hospital of Southern Medical Univesity	Foshan	Guangdong
China	Hainan General Hospital	Haikou	Hainan
China	The Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Huizhou Municipal Central Hospital	Huizhou	Guangdong
China	Huzhou Central Hospital	Huzhou	Zhejiang
China	Jinan Central Hospital	Jinan	Shandong
China	Panjin Liaoyou Baoshihua Hospital	Liaoyou	Liaoning
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang Shi	Henan
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Nanjing Medical University - Nanjing Jiangning Hospital	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	The First Affiliated Hospital of Nanyang Medical College	Nanyang	Henan
China	Jiangxi Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Jiading District Central Hospital	Shanghai	Shanghai
China	Pudong New Area People's Hospital Shanghai	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Xi'an Medical University	Xi'an	Shaanxi
China	Yichang Central People's Hospital	Yichang	Hubei
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
China	Zunyi First People's Hospital	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hemoglobin A1c (HbA1c)		Baseline, Week 40
Secondary	Percentage of Participants with HbA1c Target Values of <7.0% (<53 mmol/mol)		Week 40
Secondary	Change from Baseline in Fasting Serum Glucose		Baseline, Week 40
Secondary	Percentage of Participants with HbA1c Target Values of =6.5% (=48 mmol/mol)		Week 40
Secondary	Change from Baseline in Body Weight		Baseline, Week 40
Secondary	Percentage of Participants with HbA1c Target Values of <5.7% (<39 mmol/mol)		Week 40
Secondary	Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)		Baseline, Week 40
Secondary	Percentage of Participants Who Achieved Weight loss of =5%		Week 40
Secondary	Percentage of Participants Who Achieved Weight loss of =10%		Week 40
Secondary	Percentage of Participants Who Achieved Weight loss of =15%		Week 40