A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity
- Registration Number
- NCT06859268
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This is a study of retatrutide in participants with obesity. The main purpose is to learn more about how retatrutide maintains body weight loss. The study will have two treatment phases: an 80 week lead-in phase in which all participants will take retatrutide dose 1 and a 36 week randomized, double-blinded phase in which participants will either take retatrutide dose 1, retatrutide dose 2, or switch to placebo. Participation in the study will last around 125 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 586
- Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight
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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
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Have a prior or planned endoscopic procedure and/or device-based therapy for obesity
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Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes
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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)
- hospitalization for unstable angina, or
- hospitalization due to congestive heart failure
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Have New York Heart Association Functional Classification Class IV congestive heart failure
-
Have a history of chronic or acute pancreatitis
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Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Retatrutide Dose 1 Retatrutide Participants will receive retatrutide dose 1 administered subcutaneously (SC) for 116 weeks Retatrutide Dose 1 to Placebo Placebo Participants will receive retatrutide dose 1 administered SC for 80 weeks, then placebo administered SC for an additional 36 weeks Retatrutide Dose 1 to Retatrutide Dose 2 Retatrutide Participants will receive retatrutide dose 1 administered SC for 80 weeks, then retatrutide dose 2 administered SC for an additional 36 weeks Retatrutide Dose 1 to Placebo Retatrutide Participants will receive retatrutide dose 1 administered SC for 80 weeks, then placebo administered SC for an additional 36 weeks
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Week 0, Week 116
- Secondary Outcome Measures
Name Time Method Change from Baseline in Waist Circumference Week 0, Week 116 Percentage of Body Weight Reduction Achieved at Week 80 that is Maintained at Week 116 Week 0, Week 80, Week 116 Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Week 0, Week 116
Related Research Topics
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Trial Locations
- Locations (50)
Southern California Clinical Research
🇺🇸Santa Ana, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
CMR of Greater New Haven, LLC
🇺🇸Hamden, Connecticut, United States
ALL Medical Research, LLC
🇺🇸Cooper City, Florida, United States
Florida International Medical Research
🇺🇸Coral Gables, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Charter Research - Winter Park
🇺🇸Orlando, Florida, United States
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Kubost Clinical Research - Marietta
🇺🇸Marietta, Georgia, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Pacific Diabetes & Endocrine Center
🇺🇸Honolulu, Hawaii, United States
Alliance for Multispecialty Research, LLC
🇺🇸Knoxville, Tennessee, United States
Springfield Clinic Main Campus
🇺🇸Springfield, Illinois, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
Care Access - Lake Charles (Bayou Pines)
🇺🇸Lake Charles, Louisiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Vector Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Dent Neurosciences Research Center, Inc
🇺🇸Amherst, New York, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Care Access - Raleigh
🇺🇸Raleigh, North Carolina, United States
Tekton Research, LLC.
🇺🇸Moore, Oklahoma, United States
Altoona Center For Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Care Access - Rapid City
🇺🇸Rapid City, South Dakota, United States
Care Access - Houston
🇺🇸Houston, Texas, United States
Southern Endocrinology Associates
🇺🇸Mesquite, Texas, United States
Sleep Therapy Research Center
🇺🇸San Antonio, Texas, United States
National Clinical Research, Inc
🇺🇸Richmond, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Central Washington Health Services Association d/b/a Confluence Health
🇺🇸Wenatchee, Washington, United States
Aggarwal and Associates Limited
🇨🇦Brampton, Ontario, Canada
Circulate Cardiac & Vascular Centre
🇨🇦Burlington, Ontario, Canada
Med Trust Research
🇨🇦Courtice, Ontario, Canada
Winterberry Research Inc.
🇨🇦Hamilton, Ontario, Canada
Care Access - Thunder Bay - Barton Street
🇨🇦Thunder Bay, Ontario, Canada
Maple Leaf Research
🇨🇦Toronto, Ontario, Canada
Centre de Medecine Metabolique de Lanaudiere (CMML)
🇨🇦Terrebonne, Quebec, Canada
C.I.C. Mauricie inc.
🇨🇦Trois-Rivières, Quebec, Canada
Atlantic Medical
🇬🇧Penzance, Cornwall, United Kingdom
Rame Group Practice
🇬🇧Torpoint, Cornwall, United Kingdom
St Bartholomew's Medical Centre
🇬🇧Oxford, England, United Kingdom
Oakenhurst Medical Practice
🇬🇧Blackburn, Lancashire, United Kingdom
Layton Medical Centre
🇬🇧Blackpool, Lancashire, United Kingdom
HMC Health Group - Meadows Centre for Health
🇬🇧Hounslow, London, City Of, United Kingdom
Cheadle Community Hospital
🇬🇧Cheadle, Staffordshire, United Kingdom
Bradford on Avon Health Centre
🇬🇧Bradford on Avon, Wiltshire, United Kingdom
FutureMeds - Liverpool
🇬🇧Bromborough, Wirral, United Kingdom
FutureMeds - Birmingham
🇬🇧Birmingham, United Kingdom
The Adam Practice
🇬🇧Poole, United Kingdom
Woodstock Bower Surgery
🇬🇧Rotherham, United Kingdom