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OpenTrials
Completed

NCT Number: NCT06003465

A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices

The main purpose of this study is to look at the amount of the study drug, LY3437943, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of LY3437943 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 16 weeks, including screening.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Qps-Mra, Llc, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures
  • Body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive
  • Have clinical laboratory test results, blood pressure and pulse rate that are acceptable for the study
  • Are agreeable to receiving study treatment by injections under the skin
  • Males who agree to use highly effective/effective methods of contraception and women not of childbearing potential (postmenopausal or oophorectomized)

Exclusion criteria

  • Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
  • Smoke more than the equivalent of 10 cigarettes per day
  • Is a known user of drugs of abuse
  • Have known allergies to LY3437943 or related compounds

Treatment and study plan

LY3437943

Drug

Administered SC

TEST

Device

Used to administer LY3437943 SC

Reference

Device

Used to administer LY3437943 SC

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943

    Time frame: Predose up to 43 days postdose

    PK: Cmax of LY3437943

  2. PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of LY3437943

    Time frame: Predose up to 43 days postdose

    PK: AUC[0-tlast] of LY3437943

  3. PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943

    Time frame: Predose up to 43 days postdose

    PK: AUC(0-∞) of LY3437943

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Relative Bioavailability Study to Compare the Pharmacokinetics of LY3437943 Administered Subcutaneously by a Test Device (Test Formulation) Versus Reference Device (Reference Formulation) in Healthy Participants

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2023
Registry last updated
Mar 29, 2024

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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