A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3819469
Overview
- Phase
- Phase 1
- Intervention
- LY3819469
- Conditions
- Healthy
- Sponsor
- Eli Lilly and Company
- Enrollment
- 66
- Locations
- 5
- Primary Endpoint
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a 2-part study. In Part A, the main purpose is to evaluate the safety and tolerability of the study drug LY3819469 in healthy participants with high lipoprotein (a) [Lp(a)] levels. How the body processes the study drug and the effect of the study drug on blood Lp(a) levels will also be investigated. Part B will mainly evaluate the safety and tolerability of LY3819469 as well as how the body processes the study drug in Japanese participants. The study may last up to 53 and 29 weeks for each participant in Parts A and B, respectively.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female participants must not be able to get pregnant and male participants must agree to adhere to contraception restrictions
- •Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²)
- •For Part B, participants should be of first-generation Japanese origin
Exclusion Criteria
- •Are currently participating in or completed a clinical trial within the last 30 days
- •Are heavy alcohol drinkers or heavy cigarette smokers
- •Have donated blood of more than 500 milliliters (mL) in the last 3 months
Arms & Interventions
LY3819469 (Part A)
Single ascending doses of LY3819469 administered subcutaneously (SC).
Intervention: LY3819469
LY3819469 (Part B)
Single doses of LY3819469 administered SC in Japanese Participants.
Intervention: LY3819469
Placebo (Part A)
Placebo administered SC.
Intervention: Placebo
Placebo (Part B)
Placebo administered SC.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame: Baseline up to Week 49
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcomes
- Pharmacodynamics (PD): Change From Baseline in Fasting Lp(a)(Baseline up to Week 49)
- PK: Maximum Observed Drug Concentration (Cmax) of LY3819469(Predose through Day 15)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3819469(Predose through Day 15)