A Study to Compare Two Formulations of LY3819469 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3819469

• Registration Number: NCT05932446
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-06-28
• Study Start: 2023-06-30
• Study First Posted: 2023-07-06
• Primary Completion: 2023-11-07
• Study Completion: 2023-11-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3819469 (Reference)	LY3819469	LY3819469 administered subcutaneously (SC).
LY3819469 (Test)	LY3819469	LY3819469 administered SC.

Primary Outcome Measures

Name	Time	Method
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819469	Predose on day 1 up to postdose on day 85	PK: AUC\[0-∞\] of LY3819469
PK: Maximum Observed Concentration (Cmax) of LY3819469	Predose on day 1 up to postdose on day 85	PK: Cmax of LY3819469
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Timepoint with Measurable Concentration (AUC[0-tlast]) of LY3819469	Predose on day 1 up to postdose on day 85	PK: AUC\[0-tlast\] of LY3819469

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore