Healthy
Conditions
Keywords
Elderly, Body Weight, Body Composition
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.
Interventions
DRUGLY3549492
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada, United States
Outcome results
None listed