A Study of LY3819469 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04914546
Collaborator
(none)
66
Enrollment
5
Locations
4
Arms
16.4
Anticipated Duration (Months)
13.2
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3819469
Actual Study Start Date :
Jun 14, 2021
Anticipated Primary Completion Date :
Oct 25, 2022
Anticipated Study Completion Date :
Oct 25, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: LY3819469 (Part A)

Single ascending doses of LY3819469 administered subcutaneously (SC).

Drug: LY3819469
Administered SC.

Experimental: LY3819469 (Part B)

Single doses of LY3819469 administered SC in Japanese Participants.

Drug: LY3819469
Administered SC.

Placebo Comparator: Placebo (Part A)

Placebo administered SC.

Drug: Placebo
Administered SC.

Placebo Comparator: Placebo (Part B)

Placebo administered SC.

Drug: Placebo
Administered SC.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [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 Outcome Measures

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3819469 [Predose through Day 15]

    PK: AUC[0-∞] of LY3819469

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY3819469 [Predose through Day 15]

    PK: Cmax of LY3819469

  3. Pharmacodynamics (PD): Change From Baseline in Fasting Lp(a) [Baseline up to Week 49]

    PD: Change From Baseline in Fasting Lp(a)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1WCCT GlobalCypressCaliforniaUnited States90630
2Clinical Pharmacology of MiamiMiamiFloridaUnited States33014
3Qps-Mra, LlcMiamiFloridaUnited States33143
4Endeavor Clinical TrialsSan AntonioTexasUnited States78229
5Lilly Centre for Clinical PharmacologySingaporeSingapore138623

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04914546
Other Study ID Numbers:
  • 18075
  • J3L-MC-EZEA
First Posted:
Jun 4, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 18, 2021