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
- 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)
Albany Medical College, Division of Community Endocrinology
馃嚭馃嚫Albany, New York, United States
Medical Advancement Centers of Arizona
馃嚭馃嚫Tempe, Arizona, United States
Mary & Dick Allen Diabetes Center
馃嚭馃嚫Newport Beach, California, United States
Artemis Institute for Clinical Research
馃嚭馃嚫San Diego, California, United States
Encompass Clinical Research
馃嚭馃嚫Spring Valley, California, United States
Diablo Clinical Research, Inc.
馃嚭馃嚫Walnut Creek, California, United States
Lynn Institute of Denver
馃嚭馃嚫Aurora, Colorado, United States
Bridgeport Hospital
馃嚭馃嚫Bridgeport, Connecticut, United States
Yale University School of Medicine
馃嚭馃嚫New Haven, Connecticut, United States
Encore Medical Research
馃嚭馃嚫Hollywood, Florida, United States
Suncoast Research Group
馃嚭馃嚫Miami, Florida, United States
Onhealth Research Center
馃嚭馃嚫Miami, Florida, United States
Precision Clinical Research
馃嚭馃嚫Sunrise, Florida, United States
Einstein Clinical Research
馃嚭馃嚫Vero Beach, Florida, United States
ClinCept Clinical Research - MH
馃嚭馃嚫Columbus, Georgia, United States
Northeast Georgia Medical Center
馃嚭馃嚫Gainesville, Georgia, United States
Pivotal Research Solutions
馃嚭馃嚫Stonecrest, Georgia, United States
East-West Medical Research Institute
馃嚭馃嚫Honolulu, Hawaii, United States
Northwestern University
馃嚭馃嚫Chicago, Illinois, United States
Integrated Clinical Trial Services, Inc.
馃嚭馃嚫West Des Moines, Iowa, United States
Pennington Biomedical Research Center
馃嚭馃嚫Baton Rouge, Louisiana, United States
Great Lakes Research Group, Inc.
馃嚭馃嚫Bay City, Michigan, United States
Great Lakes Research Institute
馃嚭馃嚫Southfield, Michigan, United States
StudyMetrix Research
馃嚭馃嚫Saint Peters, Missouri, United States
Las Vegas Endocrinology
馃嚭馃嚫Henderson, Nevada, United States
New York Gastroenterology Associates
馃嚭馃嚫New York, New York, United States
Westchester Medical Center
馃嚭馃嚫Valhalla, New York, United States
PharmQuest Life Sciences, LLC
馃嚭馃嚫Greensboro, North Carolina, United States
Monroe Biomedical Research
馃嚭馃嚫Monroe, North Carolina, United States
Accellacare - Wilmington
馃嚭馃嚫Wilmington, North Carolina, United States
Lillestol Research
馃嚭馃嚫Fargo, North Dakota, United States
PriMED Clinical Research
馃嚭馃嚫Dayton, Ohio, United States
Tribe Clinical Research, LLC
馃嚭馃嚫Greenville, South Carolina, United States
WR-Clinsearch, LLC
馃嚭馃嚫Chattanooga, Tennessee, United States
Headlands Horizons LLC
馃嚭馃嚫Brownsville, Texas, United States
Next Level Urgent Care
馃嚭馃嚫Houston, Texas, United States
Houston Research Institute
馃嚭馃嚫Houston, Texas, United States
Consano Clinical Research, LLC
馃嚭馃嚫Shavano Park, Texas, United States
Chrysalis Clinical Research
馃嚭馃嚫Saint George, Utah, United States
Charlottesville Medical Research
馃嚭馃嚫Charlottesville, Virginia, United States
DIM Cl铆nica Privada
馃嚘馃嚪Ramos Mej铆a, Buenos Aires, Argentina
Centro M茅dico Viamonte
馃嚘馃嚪Buenos Aires, Ciudad Aut贸noma De Buenos Aires, Argentina
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
馃嚨馃嚤Ruda Slaska, 艢l膮skie, Poland
Consultorio de Investigaci贸n Cl铆nica EMO SRL
馃嚘馃嚪Ciudad Autonoma de Buenos Aires, Ciudad Aut贸noma De Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
馃嚘馃嚪Ciudad Autonoma de Buenos Aires, Ciudad Aut贸noma De Buenos Aires, Argentina
Centro de Investigaciones Metab贸licas (CINME)
馃嚘馃嚪Ciudad Aut贸noma de Buenos Aires, Argentina
Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob, Dr. med. Frohmut Jacob
馃嚛馃嚜Villingen-Schwenningen, Baden-W眉rttemberg, Germany
Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz
馃嚛馃嚜Lingen, Niedersachsen, Germany
InnoDiab Forschung Gmbh
馃嚛馃嚜Essen, Nordrhein-Westfalen, Germany
Medizentrum Essen Borbeck
馃嚛馃嚜Essen, Nordrhein-Westfalen, Germany
Zentrum fur klinische Forschung - K枚ln
馃嚛馃嚜K枚ln, Nordrhein-Westfalen, Germany
AmBeNet GmbH
馃嚛馃嚜Leipzig, Sachsen, Germany
RED-Institut GmbH
馃嚛馃嚜Oldenburg, Schleswig-Holstein, Germany
Diabetes Zentrum Wilhelmsburg
馃嚛馃嚜Hamburg, Germany
Diabeteszentrum Hamburg West
馃嚛馃嚜Hamburg, Germany
Gabinety TERPA
馃嚨馃嚤Lublin, Lubelskie, Poland
Ekamed
馃嚨馃嚤Lublin, Lubelskie, Poland
Gabinet Leczenia Otylosci i Chorob Dietozaleznych - dr hab. n. med. Lucyna Ostrowska
馃嚨馃嚤Bialystok, Podlaskie, Poland
Zdrowie Osteo-Medic
馃嚨馃嚤Bialystok, Podlaskie, Poland
NZOZ Specjalistyczny O艣rodek Internistyczno-Diabetologiczny
馃嚨馃嚤Bialystok, Podlaskie, Poland
Uniwersytecki Szpital Kliniczny w Bia艂ymstoku
馃嚨馃嚤Bia艂ystok, Podlaskie, Poland
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
馃嚨馃嚤Poznan, Wielkopolskie, Poland
Centrum Zdrowia Metabolicznego Pawel Bogdanski
馃嚨馃嚤Pozna艅, Wielkopolskie, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
馃嚨馃嚤Lodz, 艁贸dzkie, Poland
Ponce Medical School Foundation Inc.
馃嚨馃嚪Ponce, Puerto Rico