A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight
Eli Lilly and Company
1,217 participants
Nov 17, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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.
Exclusion Criteria11
- 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.
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Interventions
Administered SC. ISA specific interventions will be listed in the ISA.
Administered SC. ISA specific interventions will be listed in the ISA.
Administered SC. ISA specific interventions will be listed in the ISA.
Administered SC. ISA specific interventions will be listed in the ISA.
Administered orally. ISA specific interventions will be listed in the ISA.
Locations(54)
View Full Details on ClinicalTrials.gov
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NCT06143956