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A Study of LY3549492 in Healthy Weight Adult Participants

Not Applicable
Terminated
Conditions
Healthy
Interventions
Drug: Placebo
Registration Number
NCT07085468
Lead Sponsor
Eli Lilly and Company
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
1
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LY3549492 Dose 1LY3549492Participants will receive LY3549492 orally
LY3549492 Dose 2LY3549492Participants will receive LY3549492 orally
PlaceboPlaceboParticipants will receive placebo orally
Primary Outcome Measures
NameTimeMethod
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug AdministrationBaseline through Week 48

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.

Secondary Outcome Measures
NameTimeMethod
Percent Change from Baseline in Body WeightBaseline, Week 24, Week 48
Number of Participants with Adverse Events Leading to Permanent Discontinuation of Study Intervention or WithdrawalBaseline through Week 48

Trial Locations

Locations (19)

Headlands Research - Scottsdale

🇺🇸

Scottsdale, Arizona, United States

Valley Clinical Trials, Inc.

🇺🇸

Northridge, California, United States

Peninsula Research Associates

🇺🇸

Rolling Hills Estates, California, United States

Artemis Institute for Clinical Research

🇺🇸

San Diego, California, United States

JEM Research Institute

🇺🇸

Atlantis, Florida, United States

Clinical Research Atlanta

🇺🇸

Stockbridge, Georgia, United States

Great Lakes Clinical Trials - Andersonville

🇺🇸

Chicago, Illinois, United States

Alliance for Multispecialty Research, LLC

🇺🇸

Norman, Oklahoma, United States

Trial Management Associates

🇺🇸

Myrtle Beach, South Carolina, United States

Viacar Recherche Clinique

🇨🇦

Greenfield Park, Canada

Scroll for more (9 remaining)
Headlands Research - Scottsdale
🇺🇸Scottsdale, Arizona, United States
Brandon Lawrence
Principal Investigator

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