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Completed

NCT Number: NCT05959096

A Study of LY3437943 in Healthy Participants With a High Body Mass Index

The study is conducted in two parts (Part A and B). The main purpose of this study is to look at the amount of the LY3437943 that gets into the blood stream and how long it takes the body to get rid of it when given subcutaneously (SC, under the skin) in the upper arm and thigh compared to the abdomen in healthy participants with high body mass index (BMI) in Part A. In Part B, the participants receive LY3437943 intravenously (IV, through a vein) where the safety and tolerability of LY3437943 are evaluated and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 157 days and 99 days for Part A and Part B, respectively.

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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

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
  • Body mass index (BMI) between 27.0 and 45.0 kilograms per meter squared (kg/m²), inclusive
  • Are agreeable to receiving study treatment by injections under the skin or through a vein.

Exclusion criteria

  • Have a history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form)
  • Have a significant history of, or presence of, any of the following disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
  • Have known allergies to LY3437943, related compounds, or any components of the formulation
  • Smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e cigarettes (nicotine and non nicotine) per day.
  • Is a known user of drugs of abuse

Treatment and study plan

LY3437943

Drug

Administered SC

Primary outcomes

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

    Time frame: Predose on Day 1 up to 43 days postdose (Part A)

    Part A: PK: AUC(0-∞) of LY3437943

  2. Part A: PK: Maximum Concentration (Cmax) of LY3437943

    Time frame: Predose on Day 1 up to 43 days postdose (Part A)

    Part A: PK: Cmax of LY3437943

Secondary outcomes

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

    Time frame: Predose on Day 1 up to 71 days postdose (Part B)

    Part B: PK: AUC(0-∞) of LY3437943

  2. Part B: PK: Maximum Concentration (Cmax) of LY3437943

    Time frame: Predose on Day 1 up to 71 days postdose (Part B)

    Part B: PK: Cmax of LY3437943

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Effect of Injection Site on the Relative Bioavailability of a Single Dose of LY3437943 in Healthy Participants With a High Body Mass Index

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2023
Registry last updated
Oct 1, 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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