Healthy, Obesity, Overweight
Conditions
Brief summary
The purpose of this study is to see how safe and well-tolerated the drug LY3549492 is and how it behaves in the body, when given in multiple doses to healthy people who are overweight or have obesity. Participation in the study will last approximately 8 weeks.
Interventions
DRUGLY3549492
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Have a hemoglobin A1c level of less than 6.5 percent (%) at screening. * Have a body mass index (BMI) of 25.0 to 45.0 kilogram per square meter (kg/m²), inclusive, at screening * Participants assigned male at birth (AMAB) or participants assigned female at birth (AFAB) who are individual of childbearing potential (INOCBP) Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
* Have obesity induced by endocrine disorders such as Cushing's syndrome or Prader Willi syndrome. * Have any of the following conditions at screening, * supine systolic blood pressure of 160 millimeter of mercury (mmHg) or greater * supine diastolic blood pressure of 100 mmHg or greater, or * resting pulse rate of greater than 95 beats per minute (bpm) or less than 45 bpm. (Note: white-coat hypertension is excluded; therefore, if a repeated measurement of blood pressure after at least 5 minutes shows values within the range, the participant can be included). * Have had any of the following within 6-months prior to screening * myocardial infarction * unstable angina * coronary artery bypass graft * percutaneous coronary intervention. (Note: diagnostic angiograms are permitted) * transient ischemic attack * cerebrovascular accident or decompensated congestive heart failure, or * New York Health Association Class III or IV heart failure. * Have serum triglyceride of 5 millimoles per liter (mmol/L) or greater (442 milligrams per deciliter \[mg/dL\]) at screening * Have had any exposure to glucagon-like peptide-1 (GLP-1) analogs or other related compounds within the 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through end of the Follow-up Period (Week 10) | A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3549492 | Predose on Day 1 through end of the Follow-up Period (Week 10) | PK: Cmax of LY3549492 |
| PK: Observed Drug Trough Concentration (Ctrough) of LY3549492 | Predose on Day 1 through end of the Follow-up Period (Week 10) | PK: Ctrough of LY3549492 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3549492 | Predose on Day 1 through end of the Follow-up Period (Week 10) | PK: AUC of LY3549492 |
Countries
United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed