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

Description

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.

Conditions

Obesity, Overweight

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Chandler

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa, Chandler, Arizona, United States, 85225

Phoenix

HOPE Research Institute, Phoenix, Arizona, United States, 85032

Scottsdale

Headlands Research - Scottsdale, Scottsdale, Arizona, United States, 85260

Tucson

The Institute for Liver Health II dba Arizona Liver Health-Tucson, Tucson, Arizona, United States, 85712

Greenbrae

NorCal Medical Research, Inc, Greenbrae, California, United States, 94904

Huntington Park

Velocity Clinical Research, Huntington Park, Huntington Park, California, United States, 90255

Rolling Hills Estates

Peninsula Research Associates, Rolling Hills Estates, California, United States, 90274

Walnut Creek

Diablo Clinical Research, Inc., Walnut Creek, California, United States, 94598

Stamford

Stamford Therapeutics Consortium, Stamford, Connecticut, United States, 06905

Fleming Island

Northeast Research Institute (NERI), Fleming Island, Florida, United States, 32003

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have a body mass index (BMI) ≥27 kg/m²
  • * Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

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, STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2026-09