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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT05959096 (opens ClinicalTrials.gov in a new tab)Other id18532Other idJ1I-MC-GZBS
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Overview

Status
Completed
Phase
Phase 1
Enrollment
85 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
18 Jul 2023
Primary completion
25 Jul 2024
Completion
25 Jul 2024
First posted
25 Jul 2023
Last update posted
1 Oct 2024
Conditions
Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 1

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

    NCT05959096

    18 Jul 2023 to 25 Jul 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LY3437943Drug
  • LY3437943Drug

Arms2

  • Experimental

    LY3437943 (Part A)

    LY3437943 administered subcutaneously (SC) in either thigh, upper arm, or abdomen

  • Experimental

    LY3437943 (Part B)

    LY3437943 administered intravenously (IV)

Primary outcomes2

Outcomes the sponsor listed as primary.

  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)

    Registry description

    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)

    Registry description

    Part A: PK: Cmax of LY3437943

Secondary outcomes(2)

  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)

    Registry description

    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)

    Registry description

    Part B: PK: Cmax of LY3437943

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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