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

Phase 2

Not yet recruiting

• Conditions: Obesity; Overweight; Type 2 Diabetes
• Interventions: Drug: LY6249492; Drug: Placebo

• Registration Number: NCT07030868
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-13
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Study Start: 2025-07-01
• Primary Completion: 2026-09
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3549492 Dose 1	LY6249492	Participants will receive LY3549492 orally
LY3549492 Dose 2 Fast Titration	LY6249492	Participants will receive LY3549492 orally
LY3549492 Dose 2 Slow Titration	LY6249492	Participants will receive LY3549492 orally
Placebo	Placebo	Participants will receive placebo orally

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight	Baseline, Week 32

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Body Weight	Baseline, Week 32
Percentage of Participants Who Achieve ≥5% Body Weight Reduction	Baseline, Week 32
Percentage of Participants Who Achieve ≥10% Body Weight Reduction	Baseline, Week 32
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 32
Pharmacokinetics (PK): Average Concentration of LY3549492	Week 32

Trial Locations

Locations (44)

HOPE Research Institute; 🇺🇸 Phoenix, Arizona, United States

Headlands Research - Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

The Institute for Liver Health II dba Arizona Liver Health-Tucson; 🇺🇸 Tucson, Arizona, United States

NorCal Medical Research, Inc; 🇺🇸 Greenbrae, California, United States

Velocity Clinical Research, Huntington Park; 🇺🇸 Huntington Park, California, United States

Peninsula Research Associates; 🇺🇸 Rolling Hills Estates, California, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

Stamford Therapeutics Consortium; 🇺🇸 Stamford, Connecticut, United States

Northeast Research Institute (NERI); 🇺🇸 Fleming Island, Florida, United States

Indago Research & Health Center, Inc; 🇺🇸 Hialeah, Florida, United States

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