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

NCT06143956
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
1,481
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Lead sponsor
Eli Lilly and Company
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Start date
2023-11-17
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Number of sites
54
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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.
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Short title
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
clinicaltrials.gov
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
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-02-01
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First posted
2023-11-22
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Registry last updated
2026-08-06
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Primary completion date
2027-09-01
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Start date
2023-11-17
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Participants
1,481
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Participant count basis
Estimated
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Planned participants
1,481
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Protocol amendments
12
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Number of sites
54
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06143956
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ClinicalTrials.gov ID
NCT06143956
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Screening
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Number of Participants Allocated to Each ISA

    Timeframe: Baseline to Week 6

    Each ISA will detail the intervention specific analysis.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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-related comorbidity

  • 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.

Sources for eligibility
clinicaltrials.gov

  • The Institute for Liver Health II dba Arizona Clinical Trials - MesaChandler, United StatesRecruiting
  • HOPE Research InstitutePhoenix, United StatesCompleted
  • Headlands Research - ScottsdaleScottsdale, United StatesRecruiting
  • The Institute for Liver Health II dba Arizona Liver Health-TucsonTucson, United StatesRecruiting
  • NorCal Medical Research, IncGreenbrae, United StatesRecruiting
  • Velocity Clinical Research, Huntington ParkHuntington Park, United StatesRecruiting
  • Peninsula Research AssociatesRolling Hills Estates, United StatesRecruiting
  • Diablo Clinical Research, Inc.Walnut Creek, United StatesRecruiting
  • Stamford Therapeutics ConsortiumStamford, United StatesRecruiting
  • Northeast Research Institute (NERI)Fleming Island, United StatesCompleted
  • New Horizon Research CenterMiami, United StatesRecruiting
  • Indago Research & Health Center, IncMiami Lakes, United StatesRecruiting
  • Suncoast Clinical Research, Inc.New Port Richey, United StatesRecruiting
  • Charter Research - Winter ParkOrlando, United StatesRecruiting
  • Charter Research - Lady LakeThe Villages, United StatesRecruiting
  • Pacific Diabetes & Endocrine CenterHonolulu, United StatesCompleted
  • Medical Research PartnersAmmon, United StatesRecruiting
  • Great Lakes Clinical Trials - RavenswoodChicago, United StatesActive, not recruiting
  • Great Lakes Clinical Trials - RavenswoodChicago, United StatesRecruiting
  • NorthShore University Health SystemSkokie, United StatesActive, not recruiting
  • Iowa Diabetes and Endocrinology Research CenterWest Des Moines, United StatesRecruiting
  • Cotton O'Neil Diabetes & EndocrinologyTopeka, United StatesRecruiting
  • Monroe Biomedical Research - LouisvilleLouisville, United StatesRecruiting
  • KnownwellNeedham, United StatesRecruiting
  • Lucida Clinical TrialsNew Bedford, United StatesRecruiting

And 29 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • W8M-MC-CWMM
Sources for references
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Conditions (1)

Targets (2)