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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06003465

Enrollment

Registered

2023-08-22

Start date

2023-08-29

Completion date

2024-02-08

Last updated

2024-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGLY3437943

Administered SC

DEVICETest

Used to administer LY3437943 SC

DEVICEReference

Used to administer LY3437943 SC

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943	Predose up to 43 days postdose	PK: Cmax of LY3437943
PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of LY3437943	Predose up to 43 days postdose	PK: AUC\[0-tlast\] of LY3437943
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943	Predose up to 43 days postdose	PK: AUC(0-∞) of LY3437943

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026