A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity
- Registration Number
- NCT06662383
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. The study will last about 89 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight.
-
Have a self-reported change in body weight >5 kilograms (kg) (11 pounds) within 90 days before screening.
-
Have a prior or planned surgical treatment for obesity.
-
Have a prior or planned endoscopic procedure and/or device-based therapy for obesity.
-
Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
-
Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
-
Have had within the past 90 days before screening:
- acute myocardial infarction
- cerebrovascular accident (stroke)
- coronary revascularization
- hospitalization for unstable angina, or
- hospitalization due to congestive heart failure.
-
Have New York Heart Association Functional Classification Class IV congestive heart failure.
-
Have a history of chronic or acute pancreatitis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tirzepatide Tirzepatide Participants will receive tirzepatide administered SC Retatrutide Retatrutide Participants will receive retatrutide administered subcutaneously (SC)
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 80
- Secondary Outcome Measures
Name Time Method Change from Baseline in Body Mass Index (BMI) Baseline, Week 80 Change from Baseline in Waist Circumference Baseline, Week 80 Percent Change from Baseline in Total Cholesterol Baseline, Week 80 Percent Change from Baseline in Triglycerides Baseline, Week 80 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 80 Change from Baseline in Diastolic Blood Pressure (DBP) Baseline, Week 80 Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 80 Percent Change from Baseline in Fasting Insulin Baseline, Week 80 Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Baseline, Week 80
Trial Locations
- Locations (65)
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Medical Advancement Centers of Arizona
🇺🇸Tempe, Arizona, United States
Mary & Dick Allen Diabetes Center
🇺🇸Newport Beach, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Lynn Institute of Denver
🇺🇸Aurora, Colorado, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
Suncoast Research Group
🇺🇸Miami, Florida, United States
Onhealth Research Center
🇺🇸Miami, Florida, United States
Precision Clinical Research
🇺🇸Sunrise, Florida, United States
Einstein Clinical Research
🇺🇸Vero Beach, Florida, United States
ClinCept Clinical Research - MH
🇺🇸Columbus, Georgia, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Pivotal Research Solutions
🇺🇸Stonecrest, Georgia, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Integrated Clinical Trial Services, Inc.
🇺🇸West Des Moines, Iowa, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Great Lakes Research Institute
🇺🇸Southfield, Michigan, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Las Vegas Endocrinology
🇺🇸Henderson, Nevada, United States
Albany Medical College, Division of Community Endocrinology
🇺🇸Albany, New York, United States
New York Gastroenterology Associates
🇺🇸New York, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
PharmQuest Life Sciences, LLC
🇺🇸Greensboro, North Carolina, United States
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
Accellacare - Wilmington
🇺🇸Wilmington, North Carolina, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
PriMED Clinical Research
🇺🇸Dayton, Ohio, United States
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
WR-Clinsearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Headlands Horizons LLC
🇺🇸Brownsville, Texas, United States
Next Level Urgent Care
🇺🇸Houston, Texas, United States
Houston Research Institute
🇺🇸Houston, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
DIM Clínica Privada
🇦🇷Ramos Mejía, Buenos Aires, Argentina
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Consultorio de Investigación Clínica EMO SRL
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob, Dr. med. Frohmut Jacob
🇩🇪Villingen-Schwenningen, Baden-Württemberg, Germany
Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz
🇩🇪Lingen, Niedersachsen, Germany
InnoDiab Forschung Gmbh
🇩🇪Essen, Nordrhein-Westfalen, Germany
Medizentrum Essen Borbeck
🇩🇪Essen, Nordrhein-Westfalen, Germany
Zentrum fur klinische Forschung - Köln
🇩🇪Köln, Nordrhein-Westfalen, Germany
AmBeNet GmbH
🇩🇪Leipzig, Sachsen, Germany
RED-Institut GmbH
🇩🇪Oldenburg, Schleswig-Holstein, Germany
Diabetes Zentrum Wilhelmsburg
🇩🇪Hamburg, Germany
Diabeteszentrum Hamburg West
🇩🇪Hamburg, Germany
Gabinety TERPA
🇵🇱Lublin, Lubelskie, Poland
Ekamed
🇵🇱Lublin, Lubelskie, Poland
Gabinet Leczenia Otylosci i Chorob Dietozaleznych - dr hab. n. med. Lucyna Ostrowska
🇵🇱Bialystok, Podlaskie, Poland
Zdrowie Osteo-Medic
🇵🇱Bialystok, Podlaskie, Poland
NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
🇵🇱Bialystok, Podlaskie, Poland
Uniwersytecki Szpital Kliniczny w Białymstoku
🇵🇱Białystok, Podlaskie, Poland
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
🇵🇱Poznan, Wielkopolskie, Poland
Centrum Zdrowia Metabolicznego Pawel Bogdanski
🇵🇱Poznań, Wielkopolskie, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
🇵🇱Lodz, Łódzkie, Poland
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
🇵🇱Ruda Slaska, Śląskie, Poland
Ponce Medical School Foundation Inc.
🇵🇷Ponce, Puerto Rico