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

A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3549492 Once Daily Compared With Placebo in Adult Participants With Obesity or Overweight

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Placebo; Drug: LY3549492

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
      • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
    • Phoenix, Arizona, United States, 85032
      • Hope Research Institute
    • Scottsdale, Arizona, United States, 85260
      • Headlands Research - Scottsdale
    • Tucson, Arizona, United States, 85712
      • The Institute for Liver Health II dba Arizona Liver Health-Tucson
  • 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 - Andersonville
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials - Ravenswood
    • Skokie, Illinois, United States, 60077
      • Northshore University Health System
  • 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
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • 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
    • City of Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research
    • Springfield, Missouri, United States, 65807
      • Clinvest Headlands Llc
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Las Vegas Medical Research
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurologic Institute
    • East Syracuse, New York, United States, 13057
      • Velocity Clinical Research, Syracuse
    • Port Jefferson Station, New York, United States, 11776
      • North Suffolk Neurology
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, LLC
  • North Carolina
    • Greensboro, North Carolina, United States, 27405
      • Medication Management
    • 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.
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research, LLC
  • 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

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 of

  • ≥ 30 kilograms per square meter (kg/m²) or
  • ≥ 27 kg/m² and < 30 kg/m² with at least one weight-related comorbidity
• 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 or Type 1 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3549492 Dose 1; Participants will receive LY3549492 orally	Drug: LY3549492; Administered orally
Experimental: LY3549492 Dose 2; Participants will receive LY3549492 orally	Drug: LY3549492; Administered orally
Experimental: LY3549492 Dose 3; Participants will receive LY3549492 orally	Drug: LY3549492; Administered orally
Experimental: LY3549492 Dose 4; Participants will receive LY3549492 orally	Drug: LY3549492; Administered orally
Experimental: LY3549492 Dose 5; Participants will receive LY3549492 orally	Drug: LY3549492; Administered orally
Placebo Comparator: Placebo; Participants will receive Placebo orally	Drug: Placebo; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change from Baseline in Body Weight	Baseline, Week 36

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Body Weight (kilograms)	Baseline, Week 36
Percentage of Participants who Achieve ≥5% Body Weight Reduction	Baseline, Week 36
Percentage of Participants who Achieve ≥10% Body Weight Reduction	Baseline, Week 36
Change from Baseline in Body Mass Index (BMI)	Baseline, Week 36
Pharmacokinetics (PK): Average Concentration of LY3549492	Week 36

Collaborators and Investigators

• 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

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Actual): January 7, 2026
• Study Completion (Actual): May 4, 2026

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: 27240; W8M-MC-CWMM (Other Identifier: Eli Lilly and Company); W8M-MC-GN01 (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 and 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
• product manufactured in and exported from the U.S.: No