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Completed

NCT Number: NCT03841630

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

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.

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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously completed or withdrawn from this study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

Treatment and study plan

LY3437943

Drug

Administered subcutaneously (SC)

Placebo

Drug

Administered SC

Primary outcomes

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

    Time frame: 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 outcomes

  1. Pharmacokinetics: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3437943

    Time frame: Baseline through final follow-up at approximately Day 43

    Pharmacokinetics: AUC(0-inf) of LY3437943

  2. Pharmacokinetics: Maximum Concentration (Cmax) of LY3437943

    Time frame: Baseline through final follow-up at approximately Day 43

    Pharmacokinetics: Cmax of LY3437943

  3. Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY3437943

    Time frame: Baseline through final follow-up at approximately Day 43

    Pharmacokinetics: Tmax of LY3437943

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3437943 in Healthy Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2019
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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