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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-29

Study Completion Date

2024-02-08

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3437943 - Test

A single dose of LY3437943 administered by subcutaneous (SC) injection via a test device (test formulation)

Group Type EXPERIMENTAL

LY3437943

Intervention Type DRUG

Administered SC

Test

Intervention Type DEVICE

Used to administer LY3437943 SC

LY3437943 - Reference

A single dose of LY3437943 administered by SC injection via a reference device (reference formulation)

Group Type ACTIVE_COMPARATOR

LY3437943

Intervention Type DRUG

Administered SC

Reference

Intervention Type DEVICE

Used to administer LY3437943 SC

Interventions

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LY3437943

Administered SC

Intervention Type DRUG

Test

Used to administer LY3437943 SC

Intervention Type DEVICE

Reference

Used to administer LY3437943 SC

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes