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Clinical Trials in the USA / NCT06037252
Active, not recruiting Phase 2

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

NCT06037252 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2023-09-21
Last updated
2026-03-23

Condition(s) studied

Type 2 DiabetesObesity

Investigational drug(s) / intervention(s)

TirzepatidePlacebo

Tirzepatide: Administered SC

Placebo: Administered SC

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
Medical Advancement Centers of Arizona Phoenix Arizona
John Muir Physician Network Research Center Concord California
Care Access - Sacramento Sacramento California
Care Access - Aurora Aurora Colorado
Chase Medical Research, LLC Waterbury Connecticut
Retreat Medical Research Miami Florida
American Research Centers of Florida Pembroke Pines Florida
Alta Pharmaceutical Research Center Norcross Georgia
AGILE Clinical Research Trials, LLC Sandy Springs Georgia
Northwestern University Chicago Illinois
Qualmedica Research, LLC Evansville Indiana
Integrated Clinical Trial Services, Inc. West Des Moines Iowa
Accellacare - Wilmington - 1917 Tradd Court Wilmington North Carolina
Velocity Clinical Research, Mt. Auburn Cincinnati Ohio
Summit Headlands Portland Oregon
Clinical Research Associates Inc Nashville Tennessee
Juno Research Houston Texas
Southern Endocrinology Associates Mesquite Texas
Charlottesville Medical Research Charlottesville Virginia
Northwest Clinical Research Center Bellevue Washington
CEDIC CABA Buenos Aires
Consultorio de Investigación Clínica EMO SRL Ciudad Autonoma de Buenos Aires Buenos Aires
Centro Médico Viamonte Buenos Aires Buenos Aires F.D.
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Buenos Aires Buenos Aires F.D.
Centro de Investigaciones Metabólicas (CINME) Buenos Aires Argentina
Centro de Investigacion Cardiovascular y Metabólica Tijuana Estado de Baja California
Virgen Cardiovascular Research SC Guadalajara Jalisco
Cryptex Investigación Clínica S.A. de C.V. Cuauhtémoc, Ciudad de México Mexico City
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares Mexico City Mexico City
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares Ciudad Madero Tamaulipas
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Kadıköy Istanbul
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi Adana Turkey (Türkiye)
Akdeniz Universitesi Hastanesi Antalya Turkey (Türkiye)
Uludag Universitesi Bursa Turkey (Türkiye)
Dicle Üniversitesi Diyarbakır Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi Gaziantep Turkey (Türkiye)
Acibadem Universitesi Atakent Hastanesi Istanbul Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi Istanbul Turkey (Türkiye)
Ondokuz Mayıs Universitesi Samsun Turkey (Türkiye)

On this site

📄 Mounjaro (tirzepatide) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06037252 on ClinicalTrials.gov ↗ ← All trials in the USA