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
3 other identifiers
interventional
288
1 country
49
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Nov 2024
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedStudy Start
First participant enrolled
November 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedMarch 20, 2026
March 1, 2026
1.2 years
November 8, 2024
March 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline in Body Weight
Baseline, Week 36
Secondary Outcomes (5)
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
Study Arms (6)
LY3549492 Dose 1
EXPERIMENTALParticipants will receive LY3549492 orally
LY3549492 Dose 2
EXPERIMENTALParticipants will receive LY3549492 orally
LY3549492 Dose 3
EXPERIMENTALParticipants will receive LY3549492 orally
LY3549492 Dose 4
EXPERIMENTALParticipants will receive LY3549492 orally
LY3549492 Dose 5
EXPERIMENTALParticipants will receive LY3549492 orally
Placebo
PLACEBO COMPARATORParticipants will receive Placebo orally
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, 85225, United States
HOPE Research Institute
Phoenix, Arizona, 85032, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, 85712, United States
NorCal Medical Research, Inc
Greenbrae, California, 94904, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, 32003, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Charter Research - Winter Park
Orlando, Florida, 32803, United States
Charter Research - Lady Lake
The Villages, Florida, 32162, United States
Medical Research Partners
Ammon, Idaho, 83406, United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640, United States
NorthShore University Health System
Skokie, Illinois, 60077, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Knownwell
Needham, Massachusetts, 02492, United States
Lucida Clinical Trials
New Bedford, Massachusetts, 02740, United States
Headlands Research - Detroit
Southfield, Michigan, 48034, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Clinvest Headlands Llc
Springfield, Missouri, 65807, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128, United States
Dent Neurologic Institute
Amherst, New York, 14226, United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057, United States
North Suffolk Neurology
Port Jefferson Station, New York, 11776, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Medication Management
Greensboro, North Carolina, 27405, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Lucas Research, Inc
Morehead City, North Carolina, 28557, United States
Lucas Research, Inc.
New Bern, North Carolina, 28562, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Quality Medical Research
Nashville, Tennessee, 37211, United States
IMA Clinical Research Austin
Austin, Texas, 78745, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75251, United States
PlanIt Research, PLLC
Houston, Texas, 77079, United States
Tekton Research - Fredericksburg Road
San Antonio, Texas, 78229, United States
Endeavor Clinical Trials
San Antonio, Texas, 78240, United States
Texas Valley Clinical Research
Weslaco, Texas, 78596, United States
Spectrum Medical, Inc.
Danville, Virginia, 24541, United States
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, 98801, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2024
First Posted
November 12, 2024
Study Start
November 13, 2024
Primary Completion
January 7, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.