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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3493269 - SC; Drug: Placebo - SC; Drug: LY3493269 - IV

• Registration Number: NCT04178733
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-26
• Study Start: 2020-01-10
• Status Verified: 2020-05
• Primary Completion: 2020-05-11
• Study Completion: 2020-05-11
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

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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• Have previously completed or withdrawn from this study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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3493269 - Subcutaneous (SC)	LY3493269 - SC	LY3493269 administered SC.
Placebo - SC	Placebo - SC	Placebo administered SC.
LY3493269 - Intravenous (IV)	LY3493269 - IV	LY3493269 administered IV.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through final follow-up at approximately Day 43	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3493269	Baseline through final follow-up at approximately Day 43	PK: AUC of LY3493269
PK: Maximum Concentration (Cmax) of LY3493269	Baseline through final follow-up at approximately Day 43	PK: Cmax of LY3493269
PK: Time to Maximum Concentration (Tmax) of LY3493269	Baseline through final follow-up at approximately Day 43	PK: Tmax of LY3493269

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore