Clinical trial NCT06143956: A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obesity
Overweight
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-11-22
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The CWMM protocol includes screening assessments plus a framework for the subsequent intervention, which is the primary purpose of the protocol.
Primary purpose: SCREENING

Brief 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 CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI)
* ≥30 kilogram/square meter (kg/m²), or
* ≥27 kg/m² and \<30 kg/m²), or with at least 1 weight-releated comorbidity
* 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.

Primary outcomes:
measure: Number of Participants Allocated to Each ISA
timeFrame: Baseline to Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Scottsdale
country: United States
facility: Headlands Research - Scottsdale
state: Arizona
city: Tucson
country: United States
facility: The Institute for Liver Health II dba Arizona Liver Health-Tucson
state: Arizona
city: Greenbrae
country: United States
facility: NorCal Medical Research, Inc
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Fleming Island
country: United States
facility: Northeast Research Institute (NERI)
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Charter Research - Winter Park
state: Florida
city: The Villages
country: United States
facility: Charter Research - Lady Lake
state: Florida
city: Honolulu
country: United States
facility: Pacific Diabetes & Endocrine Center
state: Hawaii
city: Ammon
country: United States
facility: Medical Research Partners
state: Idaho
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Andersonville
state: Illinois
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Ravenswood
state: Illinois
city: Skokie
country: United States
facility: NorthShore University Health System
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes & Endocrinology
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Needham
country: United States
facility: Knownwell
state: Massachusetts
city: New Bedford
country: United States
facility: Lucida Clinical Trials
state: Massachusetts
city: Southfield
country: United States
facility: Headlands Research - Detroit
state: Michigan
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Headlands Llc
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: East Syracuse
country: United States
facility: Velocity Clinical Research, Syracuse
state: New York
city: Port Jefferson Station
country: United States
facility: North Suffolk Neurology
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Greensboro
country: United States
facility: Medication Management
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research, Inc
state: North Carolina
city: New Bern
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Austin
country: United States
facility: IMA Clinical Research Austin
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: San Antonio
country: United States
facility: Tekton Research - Fredericksburg Road
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Weslaco
country: United States
facility: Texas Valley Clinical Research
state: Texas
city: Danville
country: United States
facility: Spectrum Medical, Inc.
state: Virginia
city: Wenatchee
country: United States
facility: Central Washington Health Services Association d/b/a Confluence Health
state: Washington
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4550 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST
role: STUDY_DIRECTOR
References: