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

NCT06143956

RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Obesity, Overweight

Interventions: LY3305677, LY3841136, Tirzepatide, LY3549492, LY3532226

Countries: United States, Argentina

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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-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 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.

Locations (54)

Chandler, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Greenbrae, California, United States
Huntington Park, California, United States
Rolling Hills Estates, California, United States
Walnut Creek, California, United States
Stamford, Connecticut, United States
Fleming Island, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
The Villages, Florida, United States
Honolulu, Hawaii, United States
Ammon, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
West Des Moines, Iowa, United States
Topeka, Kansas, United States
Louisville, Kentucky, United States
Needham, Massachusetts, United States
New Bedford, Massachusetts, United States
Southfield, Michigan, United States
Troy, Michigan, United States
City of Saint Peters, Missouri, United States
Springfield, Missouri, United States
Las Vegas, Nevada, United States
+ 24 more on CT.gov