ACTIVE_NOT_RECRUITING

A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Retatrutide Treatment in the Maintenance of Weight Reduction in Individuals With Obesity

Quick Facts

Study Start:2025-03-05
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06859268

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight
  1. * Have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days before screening
  2. * Have a prior or planned surgical treatment for obesity
  3. * Have a prior or planned endoscopic procedure and/or device-based therapy for obesity
  4. * Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes
  5. * Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  6. * Have had within the past 90 days before screening:
  7. * acute myocardial infarction
  8. * cerebrovascular accident (stroke)
  9. * hospitalization for unstable angina, or
  10. * hospitalization due to congestive heart failure
  11. * Have New York Heart Association Functional Classification Class IV congestive heart failure
  12. * Have a history of chronic or acute pancreatitis
  13. * Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening

Contacts and Locations

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Southern California Clinical Research
Santa Ana, California, 92701
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, 06517
United States
ALL Medical Research, LLC
Cooper City, Florida, 33024
United States
Florida International Medical Research
Coral Gables, Florida, 33134
United States
Renstar Medical Research
Ocala, Florida, 34470
United States
Charter Research - Winter Park
Orlando, Florida, 32803
United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
United States
Kubost Clinical Research - Marietta
Marietta, Georgia, 30062
United States
North Georgia Clinical Research
Woodstock, Georgia, 30189
United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96817
United States
Alliance for Multispecialty Research, LLC
Oak Brook, Illinois, 60523
United States
Springfield Clinic Main Campus
Springfield, Illinois, 62703
United States
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, 40509
United States
L-MARC Research Center
Louisville, Kentucky, 40213
United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
United States
Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana, 70601
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, 64114
United States
Vector Clinical Trials
Las Vegas, Nevada, 89128
United States
Dent Neurosciences Research Center, Inc
Amherst, New York, 14226
United States
Carteret Medical Group
Morehead City, North Carolina, 28557
United States
Care Access - Raleigh
Raleigh, North Carolina, 27607
United States
Tekton Research, LLC.
Moore, Oklahoma, 73160
United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
United States
Care Access - Rapid City
Rapid City, South Dakota, 57701
United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909
United States
Care Access - Houston
Houston, Texas, 77054
United States
Southern Endocrinology Associates
Mesquite, Texas, 75149
United States
Sleep Therapy Research Center
San Antonio, Texas, 78229
United States
National Clinical Research, Inc
Richmond, Virginia, 23294
United States
Northwest Clinical Research Center
Bellevue, Washington, 98007
United States
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, 98801
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-05
Study Completion Date2028-04

Study Record Updates

Study Start Date2025-03-05
Study Completion Date2028-04

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity