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A Study of LY3819469 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04914546
Recruitment Status : Completed
First Posted : June 4, 2021
Last Update Posted : November 21, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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 disease Intervention/treatment Phase
Healthy Drug: LY3819469 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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 : June 14, 2021
Actual Primary Completion Date : November 9, 2022
Actual Study Completion Date : November 9, 2022
Arms and Interventions
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Arm Intervention/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
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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 [ 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 Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3819469 [ Time Frame: Predose through Day 15 ]
    PK: AUC[0-∞] of LY3819469

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

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04914546


Locations
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United States, California
Altasciences Clinical Los Angeles, Inc
Cypress, California, United States, 90630
United States, Florida
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014
Qps-Mra, Llc
Miami, Florida, United States, 33143
United States, Texas
Endeavor Clinical Trials
San Antonio, Texas, United States, 78229
Singapore
Lilly Centre for Clinical Pharmacology
Singapore, Singapore, 138623
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04914546    
Other Study ID Numbers: 18075
J3L-MC-EZEA ( Other Identifier: Eli Lilly and Company )
First Posted: June 4, 2021    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No