Recruiting

Phase 2

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

Sponsor:

Eli Lilly and Company

Code:

NCT06143956

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LY3305677

LY3841136

Tirzepatide

LY3549492

LY3532226

Study Details

Brief 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.

Conditions

Obesity

Overweight

Study ID

NCT06143956

Start date

Nov 17, 2023

Status verified date

Aug, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1481 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: LY3305677 Obesity ISA OXA1

Participants will receive LY3305677 or placebo subcutaneously (SC).

Each ISA will detail the intervention specific analysis.

experimental: LY3841136 Obesity ISA LAA1

Participants will receive LY3841136 or placebo SC.

Each ISA will detail the intervention specific analysis.

experimental: LY3841136 Obesity ISA LAA2

Participants will receive LY3841136, tirzepatide and placebo SC.

Each ISA will detail the intervention specific analysis.

experimental: LY3549492 Obesity ISA GN01

Participants will receive LY3549492 or placebo orally.

Each ISA will detail the intervention specific analysis.

experimental: LY3549492 Obesity ISA GN02

Participants will receive LY3549492 or placebo orally.

Each ISA will detail the intervention specific analysis.

experimental: Obesity ISA MC01

Participants will receive macupatide, eloralintide, and placebo SC.

Each ISA will detail the intervention specific analysis.

Interventions

LY3305677