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

• Status: Recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.