A Study of LY3819469 in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04914546
• Collaborator: (none)
• Enrollment: 66
• Locations: 5
• Arms: 4
• Anticipated Duration (Months): 16.8
• Patients Per Site: 13.2
• Patients Per Site Per Month: 0.8

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 Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3819469; Drug: Placebo	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: Nov 8, 2022
• Anticipated Study Completion Date: Nov 8, 2022

Arms and Interventions

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

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

	Site	City	State	Country	Postal Code
1	Altasciences Clinical Los Angeles, Inc	Cypress	California	United States	90630
2	Clinical Pharmacology of Miami	Miami	Florida	United States	33014
3	Qps-Mra, Llc	Miami	Florida	United States	33143
4	Endeavor Clinical Trials	San Antonio	Texas	United States	78229
5	Lilly Centre for Clinical Pharmacology	Singapore		Singapore	138623

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: Jul 21, 2022
• Last Verified: Jul 1, 2022

• 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 Jul 21, 2022