A Study of LY3549492 in Adults With Obesity or Overweight With Type 2 Diabetes

Lilly

Status and phase: Active, not recruiting; Phase 2

Conditions: Overweight; Obesity; Type 2 Diabetes

Treatments: Drug: LY6249492; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07030868

27321

W8M-MC-GN02 (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 treatment with LY3549492 compared to placebo in adult participants with obesity or who are overweight with type 2 diabetes.

Participation in the study will last about 11 months.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

W8M-MC-GN02:

• Assigned male at birth
• Assigned female at birth, who are of non-childbearing potential
• Have type 2 diabetes

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-GN02:

• Individuals who are of childbearing potential

• Have a history of acute or chronic pancreatitis

• Have any of the following cardiovascular conditions within 6 months prior to screening:

  • acute myocardial infarction
  • cerebrovascular accident (stroke)
  • unstable angina, or
  • hospitalization due to congestive heart failure.

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 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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150 participants in 4 patient groups, including a placebo group

LY3549492 Dose 1

Experimental group

Description:

Participants will receive LY3549492 orally

Treatment:

Drug: LY6249492

LY3549492 Dose 2 Fast Titration

Experimental group

Description:

Participants will receive LY3549492 orally

Treatment:

Drug: LY6249492

LY3549492 Dose 2 Slow Titration

Experimental group

Description:

Participants will receive LY3549492 orally

Treatment:

Drug: LY6249492

Placebo

Placebo Comparator group

Description:

Participants will receive placebo orally

Treatment:

Drug: Placebo