A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

Study Overview
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Brief Summary
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The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.

Detailed Description
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The study will include a screening period of up to 5 weeks. The primary endpoint will be at Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed approximately 4 weeks after end of treatment.

Official Title
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A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Tirzepatide Doses in Participants With Type 2 Diabetes and Obesity

Conditions
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Type 2 Diabetes, Obesity

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 a Body Mass Index (BMI) ≥35 kilogram/square meter (kg/m²) at screening. Have had stable body weight (±5%) during the 90 days preceding screening. Have been diagnosed with Type 2 Diabetes (T2D). Have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day. Exclusion Criteria: Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D. Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening. Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. Have a prior or planned surgical treatment for obesity. Use products intended for weight loss including prescription drugs, over the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening. Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45 milliliter/min (mL/min)/1.73 m². Have any of the following cardiovascular (CV) conditions within 2 months prior to screening. acute myocardial infarction. cerebrovascular accident (stroke). unstable angina . hospitalization due to congestive heart failure, or coronary artery revascularization. Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2. Have a history of chronic or acute pancreatitis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 High Dose 1<br>Participants will receive tirzepatide subcutaneously (SC). | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Experimental: Tirzepatide High Dose 2<br>Participants will receive tirzepatide SC. | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Active Comparator: Tirzepatide<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 |
| --- | --- | --- |
| Percent Change From Baseline in Body Weight |  | Baseline (Week 0), Week 44 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in HbA1c |  | Baseline (Week 0), Week 44 | 
| Change from Baseline in HbA1c |  | Baseline (Week 24), Week 80 | 
| Percent Change from Baseline in Body Weight |  | Baseline (Week 24), Week 80 | 
| Absolute Change from Baseline in Body Weight |  | Baseline (Week 0), Week 44 | 
| Absolute Change from Baseline in Body Weight |  | Baseline (Week 24), Week 80 | 
| Change from Baseline in Body Mass Index (BMI) |  | Baseline (Week 0), Week 44 | 
| Change from Baseline in BMI |  | Baseline (Week 24), Week 80 | 
| Change from Baseline in Waist Circumference |  | Baseline (Week 0), Week 44 | 
| Change from Baseline in Waist Circumference |  | Baseline (Week 24), Week 80 | 
| Percentage of Participants Achieving ≥15% Body Weight Reduction |  | Baseline (Week 0), Week 44 | 
| Percentage of Participants Achieving ≥15% Body Weight Reduction |  | Baseline (Week 0), Week 80 | 
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) | Steady State Area Under the Concentration Time Curve (AUC) presented as a single average measure of AUC across the time frame. | Baseline through Week 44 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Overnutrition, Nutrition Disorders, Body Weight, Tirzepatide, Incretins