A Study of LY3549492 in Healthy Weight Adult Participants
- 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
- 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
-
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
Group Intervention Description LY3549492 Dose 1 LY3549492 Participants will receive LY3549492 orally LY3549492 Dose 2 LY3549492 Participants will receive LY3549492 orally Placebo Placebo Participants will receive placebo orally
- Primary Outcome Measures
Name Time Method Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration Baseline 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
Name Time Method 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
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 StatesBrandon LawrencePrincipal Investigator
