Clinical trial NCT06859268: A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-03-05
Enrollment: 586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 3b
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Week 0, Week 116
Secondary outcomes:
measure: Change from Baseline in Waist Circumference
timeFrame: Week 0, Week 116
measure: Percentage of Body Weight Reduction Achieved at Week 80 that is Maintained at Week 116
timeFrame: Week 0, Week 80, Week 116
measure: Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)
timeFrame: Week 0, Week 116
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: Southern California Clinical Research
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Hamden
country: United States
facility: CMR of Greater New Haven, LLC
state: Connecticut
city: Cooper City
country: United States
facility: ALL Medical Research, LLC
state: Florida
city: Coral Gables
country: United States
facility: Florida International Medical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Charter Research - Winter Park
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Marietta
country: United States
facility: Kubost Clinical Research - Marietta
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Honolulu
country: United States
facility: Pacific Diabetes & Endocrine Center
state: Hawaii
city: Oak Brook
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic Main Campus
state: Illinois
city: Lexington
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kentucky
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Lake Charles
country: United States
facility: Care Access - Lake Charles (Bayou Pines)
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Missouri
city: Las Vegas
country: United States
facility: Vector Clinical Trials
state: Nevada
city: Amherst
country: United States
facility: Dent Neurosciences Research Center, Inc
state: New York
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Raleigh
country: United States
facility: Care Access - Raleigh
state: North Carolina
city: Moore
country: United States
facility: Tekton Research, LLC.
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Rapid City
country: United States
facility: Care Access - Rapid City
state: South Dakota
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Houston
country: United States
facility: Care Access - Houston
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy Research Center
state: Texas
city: Richmond
country: United States
facility: National Clinical Research, Inc
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Wenatchee
country: United States
facility: Central Washington Health Services Association d/b/a Confluence Health
state: Washington
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: Burlington
country: Canada
facility: Circulate Cardiac & Vascular Centre
state: Ontario
city: Courtice
country: Canada
facility: Med Trust Research
state: Ontario
city: Hamilton
country: Canada
facility: Winterberry Research Inc.
state: Ontario
city: Thunder Bay
country: Canada
facility: Care Access - Thunder Bay - Barton Street
state: Ontario
city: Toronto
country: Canada
facility: Maple Leaf Research
state: Ontario
city: Terrebonne
country: Canada
facility: Centre de Medecine Metabolique de Lanaudiere (CMML)
state: Quebec
city: Trois-Rivières
country: Canada
facility: C.I.C. Mauricie inc.
state: Quebec
city: Penzance
country: United Kingdom
facility: Atlantic Medical
state: Cornwall
city: Torpoint
country: United Kingdom
facility: Rame Group Practice
state: Cornwall
city: Oxford
country: United Kingdom
facility: St Bartholomew's Medical Centre
state: England
city: Blackburn
country: United Kingdom
facility: Oakenhurst Medical Practice
state: Lancashire
city: Blackpool
country: United Kingdom
facility: Layton Medical Centre
state: Lancashire
city: Hounslow
country: United Kingdom
facility: HMC Health Group - Meadows Centre for Health
state: London, City Of
city: Cheadle
country: United Kingdom
facility: Cheadle Community Hospital
state: Staffordshire
city: Bradford on Avon
country: United Kingdom
facility: Bradford on Avon Health Centre
state: Wiltshire
city: Bromborough
country: United Kingdom
facility: FutureMeds - Liverpool
state: Wirral
city: Birmingham
country: United Kingdom
facility: FutureMeds - Birmingham
city: Poole
country: United Kingdom
facility: The Adam Practice
city: Rotherham
country: United Kingdom
facility: Woodstock Bower Surgery
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: