A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants

Eli Lilly and Company33 enrolled

Overview

This study is being conducted to determine the side effects related to LY3493269 given as a single injection to healthy participants. Blood tests will be performed to check how much LY3493269 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3493269 or placebo. The study will last up to approximately 71 days for each participant, including screening.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

LY3493269 - SCDRUG

Administered SC

Placebo - SCDRUG

Administered SC

LY3493269 - IVDRUG

Administered IV

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Overtly healthy male or a female who cannot get pregnant * Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening * Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study * Have veins suitable for ease of blood sampling Exclusion Criteria: * Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study * Have previously completed or withdrawn from this study * Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study * Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study * Have been treated with weight loss medications within 3 months of screening

Locations (1)

Lilly Centre for Clinical Pharmacology

Singapore, Singapore

Outcomes

Primary Outcomes

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Time frame: Baseline through final follow-up (Up To Day 43)

Secondary Outcomes

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269

Pharmacokinetics (PK): Area Under the Concentration time curve from time zero to infinity (AUC 0-∞) of LY3493269

Time frame: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 and early termination

PK: Maximum Concentration (Cmax) of LY3493269

PK: Time to Maximum Concentration (Tmax) of LY3493269

Data from ClinicalTrials.gov

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