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

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Lilly

Status and phase

Not yet enrolling
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

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

Trial contacts and locations

44

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Central trial contact

There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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