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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3437943; Device: Test; Device: Reference

• Registration Number: NCT06003465
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-22
• Study Start: 2023-08-29
• Primary Completion: 2024-02-08
• Study Completion: 2024-02-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY3437943 - Test	Test	A single dose of LY3437943 administered by subcutaneous (SC) injection via a test device (test formulation)
LY3437943 - Test	LY3437943	A single dose of LY3437943 administered by subcutaneous (SC) injection via a test device (test formulation)
LY3437943 - Reference	LY3437943	A single dose of LY3437943 administered by SC injection via a reference device (reference formulation)
LY3437943 - Reference	Reference	A single dose of LY3437943 administered by SC injection via a reference device (reference formulation)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

ICON Early Phase Services; 🇺🇸 San Antonio, Texas, United States

ICON; 🇺🇸 Salt Lake City, Utah, United States

Qps-Mra, Llc; 🇺🇸 Miami, Florida, United States