A Study to Compare Two Formulations of LY3819469 in Healthy Participants

NCT05932446 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18730J3L-MC-EZEE
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to assess two formulations of LY3819469 based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3819469 will also be evaluated. Screening is required within 28 days prior to the enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening and follow-up periods.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Timepoint with Measurable Concentration (AUC[0-tlast]) of LY3819469

  PK: AUC\[0-tlast\] of LY3819469

  Predose on day 1 up to postdose on day 85

• PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819469

  PK: AUC\[0-∞\] of LY3819469

  Predose on day 1 up to postdose on day 85

• PK: Maximum Observed Concentration (Cmax) of LY3819469

  PK: Cmax of LY3819469

  Predose on day 1 up to postdose on day 85

Study Arms (2)

LY3819469 (Reference)

EXPERIMENTAL

LY3819469 administered subcutaneously (SC).

Drug: LY3819469

LY3819469 (Test)

EXPERIMENTAL

LY3819469 administered SC.

Drug: LY3819469

Interventions

LY3819469 DRUG

Administered SC.

LY3819469 (Reference); LY3819469 (Test)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants who are overtly healthy as determined by medical evaluation
• Have a body mass index (BMI) in the range of 18.5 to 35.0 kilogram per square meter (kg/m²), inclusive at the time of screening
• Are male or women not of childbearing potential

You may not qualify if:

• Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that could affect interpretation of study data
• Have any abnormality in the 12-lead electrocardiogram (ECG)
• Are heavy alcohol drinkers or heavy cigarette smokers
• Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives, or 30 days, whichever is longer, should have passed prior to CRU admission
• Have lost or donated blood of more than 450 mililitres (mL) within 3 months

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Related Publications (1)

• Dimitriadis K, Theofilis P, Iliakis P, Pyrpyris N, Dri E, Sakalidis A, Soulaidopoulos S, Tsioufis P, Fragkoulis C, Chrysohoou C, Tsiachris D, Tsioufis K. Management of dyslipidemia in coronary artery disease: the present and the future. Coron Artery Dis. 2024 Sep 1;35(6):516-524. doi: 10.1097/MCA.0000000000001375. Epub 2024 Apr 29.

  PMID: 38682459 DERIVED

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 6, 2023
• Study Start: June 30, 2023
• Primary Completion: November 7, 2023
• Study Completion: November 7, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)