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

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

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Tirzepatide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirzepatide Dose 1<br>Participants will receive tirzepatide subcutaneously (SC). | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Experimental: Tirzepatide Dose 2<br>Participants will receive tirzepatide SC. | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Experimental: Tirzepatide Dose 3<br>Participants will receive tirzepatide SC. | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Placebo Comparator: Placebo<br>Participants will receive placebo. | Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Hemoglobin A1c (HbA1c) |  | Baseline, Week 40 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 with HbA1c Target Values of ≤6.5% (≤48 mmol/mol) |  | Week 40 | 
| Change from Baseline in Body Weight |  | Baseline, 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 ≥5% |  | Week 40 | 
| Percentage of Participants Who Achieved Weight loss of ≥10% |  | Week 40 | 
| Percentage of Participants Who Achieved Weight loss of ≥15% |  | Week 40 |