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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Device: Test; Device: Reference; Drug: LY3437943

Study type: Interventional

Funder types: Industry

Identifiers

NCT06003465

18530

J1I-MC-GZBX (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

LY3437943 - Test

Experimental group

Description:

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

Treatment:

Drug: LY3437943

Device: Test

LY3437943 - Reference

Active Comparator group

Description:

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

Treatment:

Drug: LY3437943

Device: Reference