A Study of LY3549492 in Healthy Weight Adult Participants

Phase 2TerminatedNCT07085468

Eli Lilly and Company1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

LY3549492DRUG

Administered orally

PlaceboDRUG

Administered orally

Eligibility

Sex: ALLMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (21)

Headlands Research - Scottsdale

Scottsdale, Arizona, United States

Valley Clinical Trials, Inc.

Outcomes

Primary Outcomes

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.

Time frame: Baseline through Week 48

Secondary Outcomes

Percent Change from Baseline in Body Weight

Time frame: Baseline, Week 24, Week 48

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

Time frame: Baseline through Week 48

Data from ClinicalTrials.gov

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