ObesityPhase 2NCT07030868
A Study of LY3549492 in Adults With Obesity or Overweight With Type 2 Diabetes
A Phase 2 study testing LY3549492 in people with Obesity and Overweight, run by Eli Lilly and Company at 42 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Overweight, Type 2 Diabetes
- What is being tested?
- LY3549492
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 42 sitesin 2 countries
- Study dates
- 19 Jun 2025to 29 Jul 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
42 sites in 2 countries.
42 sites in 2 countries
United States38 sites
Medical Research Partners
Ammon, Idaho, 83406
IMA Clinical Research Austin
Austin, Texas, 78745
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
FutureSearch Trials of Dallas
Dallas, Texas, 75251
Spectrum Medical, Inc.
Danville, Virginia, 24541
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057
Northeast Research Institute (NERI)
Fleming Island, Florida, 32003
NorCal Medical Research, Inc
Greenbrae, California, 94904
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
PlanIt Research, PLLC
Houston, Texas, 77079
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255
Las Vegas Medical Research
Las Vegas, Nevada, 89128
New Horizon Research Center
Miami, Florida, 33165
Monroe Biomedical Research
Monroe, North Carolina, 28112
Lucas Research, Inc
Morehead City, North Carolina, 28557
Quality Medical Research
Nashville, Tennessee, 37211
Knownwell
Needham, Massachusetts, 02492
Lucida Clinical Trials
New Bedford, Massachusetts, 02740
Lucas Research, Inc.
New Bern, North Carolina, 28562
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Charter Research - Winter Park
Orlando, Florida, 32803
HOPE Research Institute
Phoenix, Arizona, 85032
Rochester Clinical Research, LLC
Rochester, New York, 14609
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Tekton Research - Fredericksburg Road
San Antonio, Texas, 78229
Endeavor Clinical Trials
San Antonio, Texas, 78240
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260
Headlands Research - Detroit
Southfield, Michigan, 48034
Clinvest Headlands Llc
Springfield, Missouri, 65807
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
Charter Research - Lady Lake
The Villages, Florida, 32162
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, 98801
Texas Valley Clinical Research
Weslaco, Texas, 78596
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266
Argentina4 sites
Centro Médico Viamonte
Buenos Aires, Buenos Aires F.D., C1120AAC
Consultorio de Investigación Clínica EMO SRL
Buenos Aires, Buenos Aires F.D., C1405BUB
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Buenos Aires F.D., C1425AGC
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI
About this study
Official title: 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.
- Conditions
- Obesity, Overweight, Type 2 Diabetes
- Being tested
- LY3549492, Placebo
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3549492Drug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY3549492 Low Dose | Experimental | Participants will receive LY3549492 orally Receives: Drug: LY3549492 |
| LY3549492 High Dose with Fast Titration | Experimental | Participants will receive LY3549492 orally Receives: Drug: LY3549492 |
| LY3549492 High Dose with Slow Titration | Experimental | Participants will receive LY3549492 orally Receives: Drug: LY3549492 |
| Placebo | Placebo comparator | Participants will receive placebo orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Body Weight
Percent change from baseline in body weight at Week 32. Body weight was intended to be measured in kilograms, and percent change was to be calculated relative to baseline.
Measured: Baseline, Week 32
Secondary outcomes (5)
Change From Baseline in Body Weight
Change from baseline in body weight at Week 32. Body weight was intended to be measured in kilograms, and absolute change from baseline was to be calculated.
Measured: Baseline, Week 32
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Percentage of participants who achieved at least 5% reduction in body weight from baseline to Week 32.
Measured: Baseline, Week 32
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Percentage of participants who achieved at least 10% reduction in body weight from baseline to Week 32.
Measured: Baseline, Week 32
Change From Baseline in Hemoglobin A1c (HbA1c)
Change from baseline in hemoglobin A1c (HbA1c) at Week 32. HbA1c was intended to be measured as a percentage and reflects average blood glucose levels over approximately 3 months.
Measured: Baseline, Week 32
Pharmacokinetics (PK): Average Concentration of LY3549492
Average plasma concentration of LY3549492. Pharmacokinetic samples were intended to be collected at multiple timepoints, including pre-dose and post-dose intervals, to evaluate the pharmacokinetic profile of LY3549492 over time.
Measured: Week 0 and Week 24 (6-18 hours post-dose); Weeks 3, 9, 15, and 18 (1-3 hours post-dose); Weeks 6 and 21 (3-6 hours post-dose); Week 12 (1-6 hours post-dose); and Weeks 30 and 32 (pre-dose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start19 Jun 2025
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Why it stopped: Study terminated for strategic business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030868
- Sponsor's protocol ID
- 27321
- Other IDs
- W8M-MC-GN02, W8M-MC-CWMM
- Status last verified
- Aug 2026
- First submitted
- 13 Jun 2025
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.