A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3841136 in Healthy and Overweight Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Study Overview
Brief Summary
The main purpose of this study is to evaluate the safety and tolerability of LY3841136 in healthy and overweight participants. Blood tests will be performed to check how much LY3841136 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and may last up to 14 and 28 weeks for each participant and may include 7 and 19 visits in parts A and B, respectively.
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
- •Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential
- •Have had a stable weight for the last 3 months
- •Have a body mass index (BMI) in the range of 18.5 to 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of 27 to 40 kg/m², both inclusive (in Part B)
Exclusion Criteria
- •Are women who are lactating
- •Have known allergies to related compounds of LY3841136 or any components of the formulation
- •Have a history of significant atopy (severe or multiple allergic manifestations), or clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
- •Have been diagnosed with Type 1 or Type 2 diabetes mellitus
- •Have a history of chronic medical conditions involving the heart, liver, or kidneys
Arms & Interventions
LY3841136 (Part A)
Single ascending doses of LY3841136 administered subcutaneously (SC).
Intervention: LY3841136 (Drug)
LY3841136 (Part B)
Multiple ascending doses of LY3841136 administered SC.
Intervention: LY3841136 (Drug)
Placebo (Part A)
Placebo administered SC.
Intervention: Placebo (Drug)
Placebo (Part B)
Placebo administered SC.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame: Predose up to 14 weeks (Part A) & 28 weeks (Part B)
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcomes
- PK: Maximum Observed Concentration (Cmax) of LY3841136(Predose through week 14 (Part A) & week 28 (Part B))
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136(Predose through week 14 (Part A) & week 28 (Part B))
- Pharmacodynamics (PD): Change From Baseline in Body Weight(Predose through week 28)