A Study to Investigate Weight Management With LY3549492 Compared With Placebo in Adult Participants With Obesity or Overweight

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: Placebo; Drug: LY3549492

Study type: Interventional

Funder types: Industry

Identifiers

NCT06683508

27240

W8M-MC-GN01 (Other Identifier)

W8M-MC-CWMM (Other Identifier)

Details and patient eligibility

About

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to evaluate the effects of LY3549492 in adults with obesity or overweight. Participation in the study will last about one year.

Enrollment: 275 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

W8M-MC-GN01:

• Assigned male at birth
• Assigned female at birth, who are of non-childbearing potential

W8M-MC-CWMM:

• Have a BMI ≥27 kilograms per square meter (kg/m²)
• Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss)

Exclusion criteria

W8M-MC-GN01:

• Have Type 2 Diabetes Mellitus
• Have a history of acute or chronic pancreatitis
• Have renal impairment
• Individuals who are of childbearing potential

W8M-MC-CWMM:

• 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: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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275 participants in 6 patient groups, including a placebo group

LY3549492 Dose 1

Experimental group

Description:

Participants will receive LY3549492 orally

Treatment:

Drug: LY3549492

LY3549492 Dose 2

Experimental group

Description:

Participants will receive LY3549492 orally

Treatment:

Drug: LY3549492

LY3549492 Dose 3

Experimental group

Description:

Participants will receive LY3549492 orally

Treatment:

Drug: LY3549492

LY3549492 Dose 4

Experimental group

Description:

Participants will receive LY3549492 orally

Treatment:

Drug: LY3549492

LY3549492 Dose 5

Experimental group

Description:

Participants will receive LY3549492 orally

Treatment:

Drug: LY3549492

Placebo

Placebo Comparator group

Description:

Participants will receive Placebo orally

Treatment:

Drug: Placebo