A Study to Compare Two Formulations of LY3819469 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3819469

Study type: Interventional

Funder types: Industry

Identifiers

NCT05932446

J3L-MC-EZEE (Other Identifier)

18730

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

27 participants in 2 patient groups

LY3819469 (Reference)

Experimental group

Description:

LY3819469 administered subcutaneously (SC).

Treatment:

Drug: LY3819469

LY3819469 (Test)

Experimental group

Description:

LY3819469 administered SC.

Treatment:

Drug: LY3819469