NCT06037252Active, not recruitingPhase 2
A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity
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
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 414 (actual)
- First submitted
- 8 Sept 2023
- Start date
- 21 Sept 2023
- Primary completion date
- 8 Jan 2026
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06037252
- EU CT number
- 2023-504561-24-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 414
- From 21 Sept 2023 to the primary completion date, 8 Jan 2026
- 40 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.
Other illness
- Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
- 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.
Lab values
- Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<45 milliliter/min (mL/min)/1.73 m².
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Investigaciones Metabólicas (CINME) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Médico Viamonte Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| CEDIC Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Consultorio de Investigación Clínica EMO SRL Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aires | Argentina | Unknown status |
| Centro de Estudios de Investigacion Metabolicos y Cardiovasculares Coordinator of this site? Confirm its status | Ciudad Madero | Mexico | Unknown status |
| Cryptex Investigación Clínica S.A. de C.V. Coordinator of this site? Confirm its status | Cuauhtémoc, Ciudad de México | Mexico | Unknown status |
| Virgen Cardiovascular Research SC Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Hospital Universitario Dr. Jose Eleuterio González Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Centro de Investigacion Cardiovascular y Metabólica Coordinator of this site? Confirm its status | Tijuana | Mexico | Unknown status |
| Care Access - Aurora Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Northwest Clinical Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Charlottesville Medical Research Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Velocity Clinical Research, Mt. Auburn Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| John Muir Physician Network Research Center Coordinator of this site? Confirm its status | Concord | United States | Unknown status |
| Qualmedica Research, LLC Coordinator of this site? Confirm its status | Evansville | United States | Unknown status |
| Juno Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Southern Endocrinology Associates Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| Retreat Medical Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Clinical Research Associates, Inc. Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Alta Pharmaceutical Research Center Coordinator of this site? Confirm its status | Norcross | United States | Unknown status |
| American Research Centers of Florida Coordinator of this site? Confirm its status | Pembroke Pines | United States | Unknown status |
| Medical Advancement Centers of Arizona Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Summit Headlands Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Care Access - Sacramento Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| AGILE Clinical Research Trials, LLC Coordinator of this site? Confirm its status | Sandy Springs | United States | Unknown status |
| Chase Medical Research, LLC Coordinator of this site? Confirm its status | Waterbury | United States | Unknown status |
| Integrated Clinical Trial Services, Inc. Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
| Accellacare - Wilmington - 1917 Tradd Court Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Akdeniz Universitesi Hastanesi Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Unknown status |
| Uludag Universitesi Coordinator of this site? Confirm its status | Bursa | Turkey (Türkiye) | Unknown status |
| Dicle Üniversitesi Coordinator of this site? Confirm its status | Diyarbakır | Turkey (Türkiye) | Unknown status |
| Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi Coordinator of this site? Confirm its status | Gaziantep | Turkey (Türkiye) | Unknown status |
| Marmara Universitesi Pendik Egitim Arastirma Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Acibadem Universitesi Atakent Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Coordinator of this site? Confirm its status | Kadıköy | Turkey (Türkiye) | Unknown status |
| Ondokuz Mayıs Universitesi Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.