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

• Status: Active, not recruiting
• Trial end date: 2024-09-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Tirzepatide

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.