Clinical trial

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

Active, not recruiting · Phase 2 · 4 countries · Registry ID NCT06037252

Active, not recruitingPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes, Obesity

Full registry 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.

Treatments and study arms

Tirzepatide

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

Percent Change From Baseline in Body WeightBaseline (Week 0), Week 44

Study locations

40 locations were listed when this page was built. The first 40 are shown.

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