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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: Tirzepatide

• Registration Number: NCT05963022
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-27
• Study Start: 2023-08-21
• Status Verified: 2024-10
• Primary Completion: 2024-10-09
• Study Completion: 2024-10-09
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo.
Tirzepatide Dose 3	Tirzepatide	Participants will receive tirzepatide SC.
Tirzepatide Dose 1	Tirzepatide	Participants will receive tirzepatide subcutaneously (SC).
Tirzepatide Dose 2	Tirzepatide	Participants will receive tirzepatide SC.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 40

Secondary Outcome Measures

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

Trial Locations

Locations (28)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Shunde Hospital of Southern Medical Univesity; 🇨🇳 Foshan, Guangdong, China

Huizhou Municipal Central Hospital; 🇨🇳 Huizhou, Guangdong, China

Zunyi First People's Hospital; 🇨🇳 Zunyi, Guizhou, China

Hainan General Hospital; 🇨🇳 Haikou, Hainan, China

The Fourth Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

The First Affiliated Hospital of Henan University of Science &Technology; 🇨🇳 Luoyang Shi, Henan, China

The First Affiliated Hospital of Nanyang Medical College; 🇨🇳 Nanyang, Henan, China

The Second Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Yichang Central People's Hospital; 🇨🇳 Yichang, Hubei, China

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