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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: LY3305677; Drug: LY3549492; Drug: Placebo; Drug: Tirzepatide; Drug: LY3841136

Study type: Interventional

Funder types: Industry

Identifiers

NCT06143956

18685

W8M-MC-CWMM (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,040 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a body mass index (BMI) ≥27 kg/m²
• 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,040 participants in 4 patient groups

LY3305677 Obesity ISA OXA1

Experimental group

Description:

Participants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis.

Treatment:

Drug: Placebo

Drug: LY3305677

LY3841136 Obesity ISA LAA1

Experimental group

Description:

Participants will receive LY3841136 or placebo SC. Each ISA will detail the intervention specific analysis.

Treatment:

Drug: LY3841136

Drug: Placebo

LY3841136 Obesity ISA LAA2

Experimental group

Description:

Participants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis.

Treatment:

Drug: LY3841136

Drug: Tirzepatide

Drug: Placebo

LY3549492 Obesity ISA GN01

Experimental group

Description:

Participants will receive LY3549492 orally. Each ISA will detail the intervention specific analysis.

Treatment:

Drug: Placebo

Drug: LY3549492