LY3549492 for healthy adults with overweight or obesity
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
This phase 1 trial will test whether LY3549492 is safe and how the body handles it when given in multiple doses to healthy adults who are overweight or have obesity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 3 sites (Daytona Beach, Florida and 2 other locations) |
| Trial ID | NCT07232732 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study gives multiple doses of LY3549492 to adults with a body mass index of 25.0–45.0 kg/m² to measure safety, tolerability, and how the drug is absorbed, distributed, metabolized, and eliminated. Participation lasts about eight weeks and includes screening, dosing, and follow-up visits. Eligible participants must have hemoglobin A1c under 6.5% and meet specified blood pressure and resting pulse limits, while people with endocrine causes of obesity are excluded. The study is sponsored by Eli Lilly and conducted at Fortrea clinical research units in Florida, Texas, and Wisconsin.
Who should consider this trial
Good fit: Ideal candidates are otherwise healthy adults with a BMI of 25.0–45.0 kg/m², hemoglobin A1c <6.5%, who meet the study's blood pressure, pulse, and contraception requirements.
Not a fit: People with obesity caused by endocrine disorders (for example Cushing's or Prader-Willi), uncontrolled hypertension or abnormal resting pulse, diabetes (HbA1c ≥6.5%), pregnant people, or those unable to attend the study sites are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, LY3549492 could become a new medication option that supports weight management by showing acceptable safety and predictable handling in the body.
How similar studies have performed: Early-phase multiple-dose studies of other investigational obesity medications have helped identify safe dosing and supported later successes, but LY3549492 itself is being tested here with limited prior human data reported publicly.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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
Where this trial is running
Daytona Beach, Florida and 2 other locations
- Fortrea Clinical Research Unit — Daytona Beach, Florida, United States (Recruiting)
- Fortrea Clinical Research Unit — Dallas, Texas, United States (Recruiting)
- Fortrea Clinical Research Unit — Madison, Wisconsin, United States (Completed)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.