A Study of LY3549492 in Healthy Participants and Participants With Overweight or Obesity

Not Applicable

Recruiting

• Conditions: Healthy; Obesity; Overweight
• Interventions: Drug: LY3549492

• Registration Number: NCT07232732
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-10-27
• Status Verified: 2025-11
• Study First Submitted: 2025-11-14
• Study First Submitted QC: 2025-11-14
• Last Update Submitted: 2025-11-14
• Study First Posted: 2025-11-18
• Last Update Posted: 2025-11-18
• Primary Completion: 2026-02
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3549492 (Treatment Group 1)	LY3549492	LY3549492 administered orally.
LY3549492 (Treatment Group 2)	LY3549492	LY3549492 administered orally.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	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 Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3549492	Predose on Day 1 through end of the Follow-up Period (Week 10)	PK: Cmax of LY3549492
PK: Observed Drug Trough Concentration (Ctrough) of LY3549492	Predose on Day 1 through end of the Follow-up Period (Week 10)	PK: Ctrough of LY3549492
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3549492	Predose on Day 1 through end of the Follow-up Period (Week 10)	PK: AUC of LY3549492

Trial Locations

Locations (1)

Fortrea Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States