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
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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-related 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 hypertens…
Interventions
- DrugLY3305677
Administered SC. ISA specific interventions will be listed in the ISA.
- DrugLY3841136
Administered SC. ISA specific interventions will be listed in the ISA.
- DrugTirzepatide
Administered SC. ISA specific interventions will be listed in the ISA.
- DrugPlacebo
Administered SC. ISA specific interventions will be listed in the ISA.
- DrugLY3549492
Administered orally. ISA specific interventions will be listed in the ISA.
Locations (53)
- The Institute for Liver Health II dba Arizona Clinical Trials - MesaChandler, Arizona
- HOPE Research InstitutePhoenix, Arizona
- Headlands Research - ScottsdaleScottsdale, Arizona
- The Institute for Liver Health II dba Arizona Liver Health-TucsonTucson, Arizona
- NorCal Medical Research, IncGreenbrae, California
- Velocity Clinical Research, Huntington ParkHuntington Park, California