A Study of LY3549492 in Healthy Weight Adult Participants

NCT07085468 | Terminated Phase 2 FDA Drug

• 2 other identifiers: 27357J3H-MC-GZNI
• Study Type: interventional
• Target: 1
• Locations: 2 countries
• Sites: 21

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in adult participants with a healthy body max index (BMI) of 22 to 25 kilograms per square meter (kg/m2). Participation in the study will last about 13 months.

Conditions

Healthy

Keywords

Elderly; Body Weight; Body Composition

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration

  A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

  Baseline through Week 48

Secondary Outcomes (2)

• Percent Change from Baseline in Body Weight

  Baseline, Week 24, Week 48

• Number of Participants with Adverse Events Leading to Permanent Discontinuation of Study Intervention or Withdrawal

  Baseline through Week 48

Study Arms (3)

LY3549492 Dose 1

EXPERIMENTAL

Participants will receive LY3549492 orally

Drug: LY3549492

LY3549492 Dose 2

EXPERIMENTAL

Participants will receive LY3549492 orally

Drug: LY3549492

Placebo

PLACEBO COMPARATOR

Participants will receive placebo orally

Drug: Placebo

Interventions

LY3549492 DRUG

Administered orally

LY3549492 Dose 1; LY3549492 Dose 2

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a body mass index (BMI) within the range of 22 to 25 kilograms per square meter (kg/m2)
• Have had a stable body weight for 3 months prior to screening

You may not qualify if:

• Have type 1 diabetes, latent autoimmune diabetes in adults, or a history of ketoacidosis or hyperosmolar coma
• Have:
• type 2 diabetes and on antidiabetic therapy (except type 2 diabetes being managed with diet and/or stable dose of metformin)
• rare forms of diabetes mellitus, or
• hemoglobin A1c (HbA1c) \>8%
• Have poorly controlled hypertension
• Have any of the following cardiovascular conditions within 12 months prior to screening:
• acute myocardial infarction
• stroke
• unstable angina, or
• hospitalization due to congestive heart failure.
• Have a history of New York Heart Association Functional Classification III or IV congestive heart failure
• Have signs and symptoms of liver disease
• Have a history of pancreatitis
• Have taken medications or alternative remedies for weight loss or weight gain within 3 months prior to screening

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (21)

Headlands Research - Scottsdale

Scottsdale, Arizona, 85260, United States

Location

Valley Clinical Trials, Inc.

Covina, California, 91723, United States

Location

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

Location

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois, 60640, United States

Location

Alliance for Multispecialty Research, LLC

Lexington, Kentucky, 40509, United States

Location

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, 73069, United States

Location

Trial Management Associates

Myrtle Beach, South Carolina, 29572, United States

Location

Viacar Recherche Clinique

Greenfield Park, J4V 2G8, Canada

Location

Apex Trials

Guelph, N1G 0B4, Canada

Location

OCT Research ULC

Kelowna, V1Y 1Z9, Canada

Location

Clinique Mémoire de Montréal

Montreal, H3G 1H9, Canada

Location

Ottawa Memory Clinic

Ottawa, K1Z 1G3, Canada

Location

Richmond Clinical Trials

Richmond, V6V 2L1, Canada

Location

Q&T Research Sherbrooke Inc.

Sherbrooke, J1J 2G2, Canada

Location

Toronto Memory Program

Toronto, M3B 2S7, Canada

Location

BioPharma Services

Toronto, M9L 3A2, Canada

Location

Diex Recherche Trois-Rivieres

Trois-Rivières, G9A 4P3, Canada

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: July 21, 2025
• Primary Completion: August 14, 2025
• Study Completion: August 14, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

CA (10); US (11)