Study Stopped
Study terminated for strategic business reasons
A Study of LY3549492 in Adults With Obesity or Overweight With Type 2 Diabetes
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)
3 other identifiers
interventional
1
2 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 obesity
Started Jun 2025
Shorter than P25 for phase_2 obesity
42 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
June 13, 2025
CompletedStudy Start
First participant enrolled
June 19, 2025
CompletedFirst Posted
Study publicly available on registry
June 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2025
CompletedAugust 29, 2025
August 1, 2025
1 month
June 13, 2025
August 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline in Body Weight
Baseline, Week 32
Secondary Outcomes (5)
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
Study Arms (4)
LY3549492 Dose 1
EXPERIMENTALParticipants will receive LY3549492 orally
LY3549492 Dose 2 Fast Titration
EXPERIMENTALParticipants will receive LY3549492 orally
LY3549492 Dose 2 Slow Titration
EXPERIMENTALParticipants will receive LY3549492 orally
Placebo
PLACEBO COMPARATORParticipants will receive placebo orally
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
HOPE Research Institute
Phoenix, Arizona, 85032, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260, 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 - Ravenswood
Chicago, Illinois, 60640, 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
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
Clinvest Headlands Llc
Springfield, Missouri, 65807, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128, United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, 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
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
Centro Médico Viamonte
Buenos Aires, Buenos Aires F.D., C1120AAC, Argentina
Consultorio de Investigación Clínica EMO SRL
Buenos Aires, Buenos Aires F.D., C1405BUB, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Buenos Aires F.D., C1425AGC, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI, Argentina
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
June 13, 2025
First Posted
June 22, 2025
Study Start
June 19, 2025
Primary Completion
July 29, 2025
Study Completion
July 29, 2025
Last Updated
August 29, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.