A Study of Single and Repeated Doses of LY3556050 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: LY3556050

Study type: Interventional

Funder types: Industry

Identifiers

NCT05341102

J2P-MC-LXBB (Other Identifier)

18327

Details and patient eligibility

About

The main purpose of this study is to conduct blood tests to measure how much LY3556050 is in the bloodstream and to determine if any age, gender, or food effects exist. The study will also evaluate the safety of LY3556050. This is a 2-part study. In Part 1, single increasing doses of LY3556050 will be given orally and participants will be confined for a 5-day period. In Part 2, multiple increasing doses of LY3556050 will be given orally and participants will be confined for a 14-day period.

Enrollment: 106 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Are overtly healthy as determined by medical evaluation.
• Participants with a body mass index (BMI) of 18.0 to 35.0 kilograms per square meter (kg/m²) and have body weight of 50 kg or more.

Exclusion criteria

• Has any history of or active cardiac disease, including congestive heart failure, angina, any arrhythmia, or clinically significant findings on Electrocardiogram (ECG).
• Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy.
• Has asthma or other severe respiratory disease.
• Is pregnant, lactating, or planning a pregnancy.
• Has active alcohol or substance abuse or history of alcohol or substance abuse within the 6 months prior to randomization.
• Any abnormal laboratory finding or vital signs outside specified parameters.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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106 participants in 4 patient groups

LY3556050 (Part 1)

Experimental group

Description:

Participants will receive single ascending doses of LY3556050 orally.

Treatment:

Drug: LY3556050

Placebo (Part 1)

Experimental group

Description:

Participants will receive placebo orally.

Treatment:

Drug: Placebo

LY3556050 (Part 2)

Experimental group

Description:

Participants will receive multiple ascending doses of LY3556050 orally.

Treatment:

Drug: LY3556050

Placebo (Part 2)

Experimental group

Description:

Participants will receive placebo orally.

Treatment:

Drug: Placebo