Status:
ACTIVE_NOT_RECRUITING
A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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. T...
Detailed Description
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 wee...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06037252
Start Date
September 21 2023
End Date
October 1 2026
Last Update
May 30 2025
Active Locations (40)
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1
Medical Advancement Centers of Arizona
Phoenix, Arizona, United States, 85044
2
John Muir Physician Network Research Center
Concord, California, United States, 94520
3
Care Access - Sacramento
Sacramento, California, United States, 95831
4
Care Access - Aurora
Aurora, Colorado, United States, 80012