HealthyPhase 2NCT07085468
A Study of LY3549492 in Healthy Weight Adult Participants
A Phase 2 study testing LY3549492 in people with Healthy, run by Eli Lilly and Company at 21 sites in 2 countries.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in adult participants with a healthy body max index (BMI) of 22 to 25 kilograms per square meter (kg/m2). Participation in the study will last about 13 months. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Healthy
- 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
- 21 sitesin 2 countries
- Study dates
- 21 Jul 2025to 14 Aug 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a body mass index (BMI) within the range of 22 to 25 kilograms per square meter (kg/m2)
- Have had a stable body weight for 3 months prior to screening
Who cannot join
- Have type 1 diabetes, latent autoimmune diabetes in adults, or a history of ketoacidosis or hyperosmolar coma
- Have:
- type 2 diabetes and on antidiabetic therapy (except type 2 diabetes being managed with diet and/or stable dose of metformin)
- rare forms of diabetes mellitus, or
- hemoglobin A1c (HbA1c) >8%
- Have poorly controlled hypertension
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- Have any of the following cardiovascular conditions within 12 months prior to screening:
- acute myocardial infarction
- stroke
- unstable angina, or
- hospitalization due to congestive heart failure.
- Have a history of New York Heart Association Functional Classification III or IV congestive heart failure
- Have signs and symptoms of liver disease
- Have a history of pancreatitis
- Have taken medications or alternative remedies for weight loss or weight gain within 3 months prior to screening
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States11 sites
JEM Research Institute
Atlantis, Florida, 33462
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640
Valley Clinical Trials, Inc.
Covina, California, 91723
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, 40509
Trial Management Associates
Myrtle Beach, South Carolina, 29572
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069
Valley Clinical Trials, Inc.
Northridge, California, 91325
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Artemis Institute for Clinical Research
San Diego, California, 92103
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Canada10 sites
Viacar Recherche Clinique
Greenfield Park, J4V 2G8
Apex Trials
Guelph, N1G 0B4
OCT Research ULC
Kelowna, V1Y 1Z9
Clinique Mémoire de Montréal
Montreal, H3G 1H9
Ottawa Memory Clinic
Ottawa, K1Z 1G3
Richmond Clinical Trials
Richmond, V6V 2L1
Q&T Research Sherbrooke Inc.
Sherbrooke, J1J 2G2
Toronto Memory Program
Toronto, M3B 2S7
BioPharma Services
Toronto, M9L 3A2
Diex Recherche Trois-Rivieres
Trois-Rivières, G9A 4P3
About this study
Official title: A Parallel-Group, Double-Blind Study to Investigate the Safety and Tolerability of LY3549492 Compared With Placebo in Adult Participants Aged 55 to 80 Years With a BMI of 22 to 25 kg/m2
The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in adult participants with a healthy body max index (BMI) of 22 to 25 kilograms per square meter (kg/m2).
Participation in the study will last about 13 months.
- Conditions
- Healthy
- Being tested
- LY3549492, Placebo
- Keywords
- Elderly, Body Weight, Body Composition
- Medical subject headings
- Body Weight
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 |
|---|---|---|
| 15 mg LY3549492 | Experimental | Participants were planned to receive 15 milligrams (mg) LY3549492 orally once daily for 48 weeks. Receives: Drug: LY3549492 |
| 60 mg LY3549492 | Experimental | Participants were planned to receive 60 mg LY3549492 orally once daily for 48 weeks. Receives: Drug: LY3549492 |
| Placebo | Placebo comparator | Participants were planned to receive matching placebo orally once daily for 48 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
Measured: Baseline through Week 48
Secondary outcomes (2)
Percent Change From Baseline in Body Weight
Measured: Baseline, Week 24, Week 48
Number of Participants With Adverse Events Leading to Permanent Discontinuation of Study Intervention or Withdrawal
Measured: Baseline through Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start21 Jul 2025
- Primary completion14 Aug 2025
- Study completion14 Aug 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 HealthyStudies 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
- Basic science
- 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
- NCT07085468
- Sponsor's protocol ID
- 27357
- Other IDs
- J3H-MC-GZNI
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2025
- Last updated
- 21 Sep 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.