A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: LY3437943

• Registration Number: NCT03841630
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This study is being conducted to determine the side effects related to LY3437943 given as a single injection under the skin to healthy participants. Blood tests will be performed to check how much LY3437943 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3437943 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: 2019-02-13
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Study Start: 2019-03-13
• Primary Completion: 2019-07-25
• Study Completion: 2019-07-25
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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• Have previously completed or withdrawn from this study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
Placebo	Placebo	Matching placebo administered as an injection under the skin in healthy participants
LY3437943	LY3437943	Escalating doses of LY3437943 administered as an injection under the skin in healthy participants

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: Maximum Concentration (Cmax) of LY3437943	Baseline through final follow-up at approximately Day 43	Pharmacokinetics: Cmax of LY3437943
Pharmacokinetics: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3437943	Baseline through final follow-up at approximately Day 43	Pharmacokinetics: AUC(0-inf) of LY3437943
Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY3437943	Baseline through final follow-up at approximately Day 43	Pharmacokinetics: Tmax of LY3437943

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore