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

NCT07232732 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27786J3H-MC-GZNJ
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy; Obesity; Overweight

Outcome Measures

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

  A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

  Baseline through end of the Follow-up Period (Week 10)

Secondary Outcomes (3)

• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3549492

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

• PK: Observed Drug Trough Concentration (Ctrough) of LY3549492

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

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY3549492

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

Study Arms (4)

LY3549492 (Treatment Group 1)

EXPERIMENTAL

LY3549492 administered orally.

Drug: LY3549492

LY3549492 (Treatment Group 2)

EXPERIMENTAL

LY3549492 administered orally.

Drug: LY3549492

LY3549492 (Treatment Group 3)

EXPERIMENTAL

LY3549492 administered orally.

Drug: LY3549492

LY3549492 (Treatment Group 4)

EXPERIMENTAL

LY3549492 administered orally.

Drug: LY3549492

Interventions

LY3549492 DRUG

Administered orally

LY3549492 (Treatment Group 1); LY3549492 (Treatment Group 2); LY3549492 (Treatment Group 3); LY3549492 (Treatment Group 4)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

RECRUITING

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

RECRUITING

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

COMPLETED

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)