Using retatrutide to help maintain weight loss in people with obesity
A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Retatrutide Treatment in the Maintenance of Weight Reduction in Individuals With Obesity
PHASE3 · Eli Lilly and Company · NCT06859268
This study is testing if the medication retatrutide can help people with obesity keep off the weight they’ve lost.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 586 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company (industry) |
| Locations | 53 sites (Santa Ana, California and 52 other locations) |
| Trial ID | NCT06859268 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of retatrutide in maintaining weight loss among individuals with obesity. Participants will undergo an 80-week lead-in phase where all will receive retatrutide dose 1, followed by a 36-week randomized, double-blinded phase where they will either continue with retatrutide or switch to a placebo. The total duration of participation in the study is approximately 125 weeks. The goal is to understand how well retatrutide helps sustain weight loss over time.
Who should consider this trial
Good fit: Ideal candidates are individuals with obesity who have previously attempted to lose weight through diet without success.
Not a fit: Patients who have undergone recent weight loss surgeries or have certain medical conditions, such as diabetes or a history of specific cancers, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for individuals struggling to maintain weight loss after dieting.
How similar studies have performed: Other studies have shown promise with similar weight management approaches, but the specific use of retatrutide in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight Exclusion Criteria: * 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 Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes * 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 * Have New York Heart Association Functional Classification Class IV congestive heart failure * Have a history of chronic or acute pancreatitis * Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening
Where this trial is running
Santa Ana, California and 52 other locations
- Southern California Clinical Research — Santa Ana, California, United States (RECRUITING)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (RECRUITING)
- CMR of Greater New Haven, LLC — Hamden, Connecticut, United States (RECRUITING)
- ALL Medical Research, LLC — Cooper City, Florida, United States (RECRUITING)
- Florida International Medical Research — Coral Gables, Florida, United States (RECRUITING)
- Renstar Medical Research — Ocala, Florida, United States (RECRUITING)
- Charter Research - Winter Park — Orlando, Florida, United States (RECRUITING)
- Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States (RECRUITING)
- Kubost Clinical Research - Marietta — Marietta, Georgia, United States (RECRUITING)
- North Georgia Clinical Research — Woodstock, Georgia, United States (RECRUITING)
- Pacific Diabetes & Endocrine Center — Honolulu, Hawaii, United States (RECRUITING)
- Alliance for Multispecialty Research, LLC — Oak Brook, Illinois, United States (RECRUITING)
- Springfield Clinic Main Campus — Springfield, Illinois, United States (RECRUITING)
- Alliance for Multispecialty Research, LLC — Lexington, Kentucky, United States (RECRUITING)
- L-MARC Research Center — Louisville, Kentucky, United States (RECRUITING)
- Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (RECRUITING)
- Care Access - Lake Charles (Bayou Pines) — Lake Charles, Louisiana, United States (RECRUITING)
- Massachusetts General Hospital — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
- Alliance for Multispecialty Research, LLC — Kansas City, Missouri, United States (RECRUITING)
- Vector Clinical Trials — Las Vegas, Nevada, United States (RECRUITING)
- Dent Neurosciences Research Center, Inc — Amherst, New York, United States (RECRUITING)
- Carteret Medical Group — Morehead City, North Carolina, United States (RECRUITING)
- Care Access - Raleigh — Raleigh, North Carolina, United States (RECRUITING)
- Tekton Research, LLC. — Moore, Oklahoma, United States (RECRUITING)
- Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States (RECRUITING)
- Care Access - Rapid City — Rapid City, South Dakota, United States (RECRUITING)
- Alliance for Multispecialty Research, LLC — Knoxville, Tennessee, United States (RECRUITING)
- Care Access - Houston — Houston, Texas, United States (RECRUITING)
- Southern Endocrinology Associates — Mesquite, Texas, United States (RECRUITING)
- Sleep Therapy Research Center — San Antonio, Texas, United States (RECRUITING)
- National Clinical Research, Inc — Richmond, Virginia, United States (RECRUITING)
- Northwest Clinical Research Center — Bellevue, Washington, United States (RECRUITING)
- Central Washington Health Services Association d/b/a Confluence Health — Wenatchee, Washington, United States (RECRUITING)
- Aggarwal and Associates Limited — Brampton, Ontario, Canada (RECRUITING)
- Circulate Cardiac & Vascular Centre — Burlington, Ontario, Canada (RECRUITING)
- Med Trust Research — Courtice, Ontario, Canada (RECRUITING)
- Winterberry Research Inc. — Hamilton, Ontario, Canada (RECRUITING)
- Care Access - Thunder Bay - Barton Street — Thunder Bay, Ontario, Canada (RECRUITING)
- Maple Leaf Research — Toronto, Ontario, Canada (RECRUITING)
- Centre de Medecine Metabolique de Lanaudiere (CMML) — Terrebonne, Quebec, Canada (NOT_YET_RECRUITING)
- C.I.C. Mauricie inc. — Trois-Rivières, Quebec, Canada (RECRUITING)
- Atlantic Medical — Penzance, Cornwall, United Kingdom (RECRUITING)
- Rame Group Practice — Torpoint, Cornwall, United Kingdom (RECRUITING)
- St Bartholomew's Medical Centre — Oxford, England, United Kingdom (RECRUITING)
- Oakenhurst Medical Practice — Blackburn, Lancashire, United Kingdom (RECRUITING)
- Layton Medical Centre — Blackpool, Lancashire, United Kingdom (RECRUITING)
- HMC Health Group - Meadows Centre for Health — Hounslow, London, City Of, United Kingdom (RECRUITING)
- Cheadle Community Hospital — Cheadle, Staffordshire, United Kingdom (RECRUITING)
- Bradford on Avon Health Centre — Bradford on Avon, Wiltshire, United Kingdom (RECRUITING)
- FutureMeds - Liverpool — Bromborough, Wirral, United Kingdom (RECRUITING)
+3 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity