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

August 25, 2025 updated by: Eli Lilly and Company

A Phase 2, Parallel-Group, Double-Blind 4-arm Study to Investigate the Effects of Treatment With LY3549492 Tablets Compared With Placebo in an Obese or Overweight Population With Type-2 Diabetes (T2D)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1056ABI
        • Centro de Investigaciones Metabólicas (CINME)
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1120AAC
        • Centro Medico Viamonte
      • Buenos Aires, Buenos Aires F.D., Argentina, C1425AGC
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
      • Buenos Aires, Buenos Aires F.D., Argentina, C1405BUB
        • Consultorio de Investigacion Clinica EMO SRL
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • HOPE Research Institute
      • Scottsdale, Arizona, United States, 85260
        • Headlands Research - Scottsdale
    • California
      • Greenbrae, California, United States, 94904
        • NorCal Medical Research, Inc
      • Huntington Park, California, United States, 90255
        • Velocity Clinical Research, Huntington Park
      • Rolling Hills Estates, California, United States, 90274
        • Peninsula Research Associates
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consortium
    • Florida
      • Fleming Island, Florida, United States, 32003
        • Northeast Research Institute (NERI)
      • Hialeah, Florida, United States, 33012
        • Indago Research & Health Center, Inc
      • Miami, Florida, United States, 33165
        • New Horizon Research Center
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
      • Orlando, Florida, United States, 32803
        • Charter Research - Winter Park
      • The Villages, Florida, United States, 32162
        • Charter Research - Lady Lake
    • Idaho
      • Ammon, Idaho, United States, 83406
        • Medical Research Partners
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials - Ravenswood
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Diabetes and Endocrinology Research Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Diabetes & Endocrinology
    • Massachusetts
      • Needham, Massachusetts, United States, 02492
        • Knownwell
      • New Bedford, Massachusetts, United States, 02740
        • Lucida Clinical Trials
    • Michigan
      • Southfield, Michigan, United States, 48034
        • Headlands Research - Detroit
      • Troy, Michigan, United States, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest Headlands Llc
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Las Vegas Medical Research
    • New York
      • East Syracuse, New York, United States, 13057
        • Velocity Clinical Research, Syracuse
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, LLC
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research
      • Morehead City, North Carolina, United States, 28557
        • Lucas Research, Inc
      • New Bern, North Carolina, United States, 28562
        • Lucas Research, Inc.
    • Tennessee
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research
    • Texas
      • Austin, Texas, United States, 78745
        • IMA Clinical Research Austin
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
      • Dallas, Texas, United States, 75251
        • FutureSearch Trials of Dallas
      • Houston, Texas, United States, 77079
        • PlanIt Research, PLLC
      • San Antonio, Texas, United States, 78240
        • Endeavor Clinical Trials
      • San Antonio, Texas, United States, 78229
        • Tekton Research - Fredericksburg Road
      • Weslaco, Texas, United States, 78596
        • Texas Valley Clinical Research
    • Virginia
      • Danville, Virginia, United States, 24541
        • Spectrum Medical, Inc.
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Central Washington Health Services Association d/b/a Confluence Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo orally
Drug: Placebo
Administered orally
Experimental: LY3549492 Dose 1
Participants will receive LY3549492 orally
Drug: LY6249492
Administered orally
Experimental: LY3549492 Dose 2 Fast Titration
Participants will receive LY3549492 orally
Drug: LY6249492
Administered orally
Experimental: LY3549492 Dose 2 Slow Titration
Participants will receive LY3549492 orally
Drug: LY6249492
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 32
Baseline, Week 32

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2025

Primary Completion (Actual)

July 29, 2025

Study Completion (Actual)

July 29, 2025

Study Registration Dates

First Submitted

June 13, 2025

First Submitted That Met QC Criteria

June 13, 2025

First Posted (Actual)

June 22, 2025

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27321
  • W8M-MC-CWMM (Other Identifier: Eli Lilly and Company)
  • W8M-MC-GN02 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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