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Active, Not Recruiting

NCT Number: NCT07232732

A Study of LY3549492 in Healthy Participants and 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit, Daytona Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3549492

Drug

Administered orally

Primary outcomes

  1. 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

Secondary outcomes

  1. 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: Cmax of LY3549492

  2. PK: Observed Drug Trough Concentration (Ctrough) of LY3549492

    Time frame: Predose on Day 1 through end of the Follow-up Period (Week 10)

    PK: Ctrough of LY3549492

  3. 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)

    PK: AUC of LY3549492

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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