A Chronic Weight Management Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

Obesity Clinical Trial

Official title:

A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143956
• Other study ID #: 18685
• Secondary ID: W8M-MC-CWMM
• Status: Recruiting
• Phase: Phase 2
• Start date: November 17, 2023
• Est. completion date: September 5, 2025

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

Description:

The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The results for the CWMM screening record will be reported when all the ISA's complete.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: September 5, 2025
• Est. primary completion date: June 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Have a Body Mass Index (BMI) =30 kilograms per square meter (kg/m²)

• Have a BMI =27 kg/m²and <30 kg/m² with at least one of the following weight-related comorbidities:

• hypertension: on blood pressure (BP)-lowering medication.

• dyslipidemia: on lipid-lowering medication

• cardiovascular (CV) disease: for example, ischemic CV disease, New York Heart Association (NYHA) Functional Classification Class I or II heart failure.

• obstructive sleep apnea

• Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss.

Exclusion Criteria:

• Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed >1 year prior to screening.

• Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.

• Have poorly controlled hypertension.

• Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.

• Have any of the following cardiovascular conditions within 3 months prior to screening:

• acute myocardial infarction

• cerebrovascular accident (stroke)

• unstable angina, or

• hospitalization due to congestive heart failure.

• Have a history of symptomatic gallbladder disease within the past 2 years.

• Have a lifetime history of suicide attempts.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• LY3305677
Administered SC. ISA specific interventions will be listed in the ISA.
• LY3841136
Administered SC. ISA specific interventions will be listed in the ISA.
• Placebo
Administered SC. ISA specific interventions will be listed in the ISA.

Locations

Country	Name	City	State
United States	Dent Neurologic Institute	Amherst	New York
United States	Medical Research Partners	Ammon	Idaho
United States	IMA Clinical Research Austin	Austin	Texas
United States	Great Lakes Clinical Trials - Andersonville	Chicago	Illinois
United States	Great Lakes Clinical Trials - Ravenswood	Chicago	Illinois
United States	CTI-CRC	Cincinnati	Ohio
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	Spectrum Medical, Inc.	Danville	Virginia
United States	Clarity Clinical Research	East Syracuse	New York
United States	Northeast Research Institute (NERI)	Fleming Island	Florida
United States	NorCal Medical Research, Inc	Greenbrae	California
United States	Medication Management	Greensboro	North Carolina
United States	Tribe Clinical Research, LLC	Greenville	South Carolina
United States	Indago Research & Health Center, Inc	Hialeah	Florida
United States	Pacific Diabetes & Endocrine Center	Honolulu	Hawaii
United States	Endocrine Ips, Pllc	Houston	Texas
United States	National Research Institute - Huntington Park	Huntington Park	California
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	L-MARC Research Center	Louisville	Kentucky
United States	The Institute for Liver Health dba Arizona Clinical Trials	Mesa	Arizona
United States	New Horizon Research Center	Miami	Florida
United States	Monroe Biomedical Research	Monroe	North Carolina
United States	Lucas Research, Inc	Morehead City	North Carolina
United States	Quality Medical Research	Nashville	Tennessee
United States	Knownwell	Needham	Massachusetts
United States	Lucida Clinical Trials	New Bedford	Massachusetts
United States	Lucas Research - New Bern	New Bern	North Carolina
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Hope Research Institute	Phoenix	Arizona
United States	North Suffolk Neurology	Port Jefferson Station	New York
United States	Rochester Clinical Research, LLC	Rochester	New York
United States	Peninsula Research Associates	Rolling Hills Estates	California
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Endeavor Clinical Trials	San Antonio	Texas
United States	Tekton Research - Fredericksburg Road	San Antonio	Texas
United States	Headlands Research - Scottsdale	Scottsdale	Arizona
United States	NorthShore University Health System	Skokie	Illinois
United States	Headlands Research - Detroit	Southfield	Michigan
United States	Clinvest Research LLC	Springfield	Missouri
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Charter Research - Lady Lake	The Villages	Florida
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan
United States	The Institute for Liver Health II dba Arizona Liver Health-Tucson	Tucson	Arizona
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Central Washington Health Services Association d/b/a Confluence Health	Wenatchee	Washington
United States	Texas Valley Clinical Research	Weslaco	Texas
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa
United States	Charter Research - Winter Park	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Allocated to Each ISA	Each ISA will detail the intervention specific analysis.	Baseline to Week 48