A Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4167586 in Participants With Obesity or Overweight Who Are Otherwise Healthy
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Number and Incidence of Serious Adverse Events (SAEs)
Study Overview
Brief Summary
The purpose of this study is to look at how safe and well-tolerated LY4167586 is in participants with obesity or overweight who are otherwise healthy. Blood tests will be performed to check how much LY4167586 gets into the bloodstream and how long it takes the body to eliminate it following a single administration. Participation in the study will last approximately 7 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participant must be 21 for Singapore site
- •Have a body mass index (BMI) between 27.0 kilogram per square meter (kg/m²) and 35.0 kg/m², inclusive
- •Have had a self-reported stable weight for 3 months prior to screening (less than approximately 5 percent [%] body weight change)
Exclusion Criteria
- •Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study drug, or of interfering with the interpretation of data.
- •Is an individual of childbearing potential (IOCBP)
Arms & Interventions
LY4167586 (Cohort B)
LY4167586 administered intravenously (IV)
Intervention: LY4167586 (Drug)
LY4167586 (Cohorts A1 to A6)
LY4167586 administered subcutaneously (SC)
Intervention: LY4167586 (Drug)
Placebo (Cohorts A1 to A6)
Placebo administered SC
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number and Incidence of Serious Adverse Events (SAEs)
Time Frame: Baseline to study completion (up to 29 weeks)
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcomes
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax)(Predose on Day 1 through end of the Follow-up Period (Week 25))
- PK: Time of Maximum Drug Concentration (tmax)(Predose on Day 1 through end of the Follow-up Period (Week 25))
- PK: Area Under the Concentration Versus Time Curve (AUC)(Predose on Day 1 through end of the Follow-up Period (Week 25))