A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Type 2 Diabetes, Obesity
In brief
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.
Key facts
- Study ID
- NCT06037252
- Run by
- Eli Lilly and Company
- People needed
- 414
- Starts
- 2023-09-21
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-03-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Medical Advancement Centers of Arizona — Phoenix, Arizona, United States
- John Muir Physician Network Research Center — Concord, California, United States
- Care Access - Sacramento — Sacramento, California, United States
- Care Access - Aurora — Aurora, Colorado, United States
- Chase Medical Research, LLC — Waterbury, Connecticut, United States
- Retreat Medical Research — Miami, Florida, United States
- American Research Centers of Florida — Pembroke Pines, Florida, United States
- Alta Pharmaceutical Research Center — Norcross, Georgia, United States
- AGILE Clinical Research Trials, LLC — Sandy Springs, Georgia, United States
- Northwestern University — Chicago, Illinois, United States
- Qualmedica Research, LLC — Evansville, Indiana, United States
- Integrated Clinical Trial Services, Inc. — West Des Moines, Iowa, United States
- Accellacare - Wilmington - 1917 Tradd Court — Wilmington, North Carolina, United States
- Velocity Clinical Research, Mt. Auburn — Cincinnati, Ohio, United States
- Summit Headlands — Portland, Oregon, United States
- Clinical Research Associates Inc — Nashville, Tennessee, United States
- Juno Research — Houston, Texas, United States
- Southern Endocrinology Associates — Mesquite, Texas, United States
- Charlottesville Medical Research — Charlottesville, Virginia, United States
- Northwest Clinical Research Center — Bellevue, Washington, United States
- CEDIC — CABA, Buenos Aires, Argentina
- Consultorio de Investigación Clínica EMO SRL — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Centro Médico Viamonte — Buenos Aires, Buenos Aires F.D., Argentina
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Buenos Aires, Buenos Aires F.D., Argentina
- Centro de Investigaciones Metabólicas (CINME) — Buenos Aires, Argentina
Full record on ClinicalTrials.gov
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