HealthyPhase 1NCT07232732
A Study of LY3549492 in Healthy Participants and Participants With Overweight or Obesity
A Phase 1 study testing LY3549492 in people with Healthy and Obesity, run by Eli Lilly and Company at 3 sites in United States.
Trial summary
The purpose of this study is to see how safe and well-tolerated the drug LY3549492 is and how it behaves in the body, when given in multiple doses to healthy people who are overweight or have obesity. Participation in the study will last approximately 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Obesity, Overweight
- What is being tested?
- LY3549492
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Oct 2025to 16 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a hemoglobin A1c level of less than 6.5 percent (%) at screening.
- Have a body mass index (BMI) of 25.0 to 45.0 kilogram per square meter (kg/m²), inclusive, at screening
- Participants assigned male at birth (AMAB) or participants assigned female at birth (AFAB) who are individual of childbearing potential (INOCBP) Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Have obesity induced by endocrine disorders such as Cushing's syndrome or Prader Willi syndrome.
- Have any of the following conditions at screening,
- supine systolic blood pressure of 160 millimeter of mercury (mmHg) or greater
- supine diastolic blood pressure of 100 mmHg or greater, or
- resting pulse rate of greater than 95 beats per minute (bpm) or less than 45 bpm. (Note: white-coat hypertension is excluded; therefore, if a repeated measurement of blood pressure after at least 5 minutes shows values within the range, the participant can be included).
- Have had any of the following within 6-months prior to screening
Show all 15Show fewer
- myocardial infarction
- unstable angina
- coronary artery bypass graft
- percutaneous coronary intervention. (Note: diagnostic angiograms are permitted)
- transient ischemic attack
- cerebrovascular accident or decompensated congestive heart failure, or
- New York Health Association Class III or IV heart failure.
- Have serum triglyceride of 5 millimoles per liter (mmol/L) or greater (442 milligrams per deciliter [mg/dL]) at screening
- Have had any exposure to glucagon-like peptide-1 (GLP-1) analogs or other related compounds within the 3 months prior to screening
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fortrea Clinical Research Unit
Dallas, Texas, 75247
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
Fortrea Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Phase-1, Parallel-Design, Open-Label, Randomized, Multiple-Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3549492 in Healthy Participants With Overweight or Obesity
The purpose of this study is to see how safe and well-tolerated the drug LY3549492 is and how it behaves in the body, when given in multiple doses to healthy people who are overweight or have obesity. Participation in the study will last approximately 8 weeks.
- Conditions
- Healthy, Obesity, Overweight
- Being tested
- LY3549492
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3549492Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY3549492 (Treatment Group 1) | Experimental | LY3549492 administered orally. Receives: Drug: LY3549492 |
| LY3549492 (Treatment Group 2) | Experimental | LY3549492 administered orally. Receives: Drug: LY3549492 |
| LY3549492 (Treatment Group 3) | Experimental | LY3549492 administered orally. Receives: Drug: LY3549492 |
| LY3549492 (Treatment Group 4) | Experimental | LY3549492 administered orally. Receives: Drug: LY3549492 |
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 Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through end of the Follow-up Period (Week 10)
Secondary outcomes (3)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3549492
PK: Cmax of LY3549492
Measured: Predose on Day 1 through end of the Follow-up Period (Week 10)
PK: Observed Drug Trough Concentration (Ctrough) of LY3549492
PK: Ctrough of LY3549492
Measured: Predose on Day 1 through end of the Follow-up Period (Week 10)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3549492
PK: AUC of LY3549492
Measured: Predose on Day 1 through end of the Follow-up Period (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start27 Oct 2025
- Primary completion16 Jul 2026
- Study completion16 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232732
- Sponsor's protocol ID
- 27786
- Other IDs
- J3H-MC-GZNJ
- Status last verified
- Aug 2026
- First submitted
- 14 Nov 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-1, Parallel-Design, Open-Label, Randomized, Multiple-Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3549492 in Healthy Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07232732
- Acronym / sponsor ID
- 27786
- Conditions
- Healthy, Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 16 Jul 2026 (actual)
- Study completion
- 16 Jul 2026 (actual)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see how safe and well-tolerated the drug LY3549492 is and how it behaves in the body, when given in multiple doses to healthy people who are overweight or have obesity. Participation in the study will last approximately 8 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3549492 (Treatment Group 1) | Experimental | Drug: LY3549492LY3549492 administered orally. |
| LY3549492 (Treatment Group 2) | Experimental | Drug: LY3549492LY3549492 administered orally. |
| LY3549492 (Treatment Group 3) | Experimental | Drug: LY3549492LY3549492 administered orally. |
| LY3549492 (Treatment Group 4) | Experimental | Drug: LY3549492LY3549492 administered orally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a hemoglobin A1c level of less than 6.5 percent (%) at screening.
- Have a body mass index (BMI) of 25.0 to 45.0 kilogram per square meter (kg/m²), inclusive, at screening
- Participants assigned male at birth (AMAB) or participants assigned female at birth (AFAB) who are individual of childbearing potential (INOCBP) Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Key exclusion criteria (15 listed)
- Have obesity induced by endocrine disorders such as Cushing's syndrome or Prader Willi syndrome.
- Have any of the following conditions at screening,
- Have had any of the following within 6-months prior to screening
- Have serum triglyceride of 5 millimoles per liter (mmol/L) or greater (442 milligrams per deciliter [mg/dL]) at screening
- Have had any exposure to glucagon-like peptide-1 (GLP-1) analogs or other related compounds within the 3 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3549492Administered orally | Drug | LY3549492 (Treatment Group 1), LY3549492 (Treatment Group 2), LY3549492 (Treatment Group 3), LY3549492 (Treatment Group 4) |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline through end of the Follow-up Period (Week 10)
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
3 secondary outcomes
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3549492
Time frame: Predose on Day 1 through end of the Follow-up Period (Week 10)
PK: Observed Drug Trough Concentration (Ctrough) of LY3549492
Time frame: Predose on Day 1 through end of the Follow-up Period (Week 10)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3549492
Time frame: Predose on Day 1 through end of the Follow-up Period (Week 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3549492 in people with Healthy and Obesity, run by Eli Lilly and Company at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through end of the Follow-up Period (Week 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.