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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3437943; Device: Test; Device: Reference

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143-4875
      • Qps-Mra, Llc
  • Texas
    • San Antonio, Texas, United States, 78209
      • ICON Early Phase Services
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • ICON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3437943 - Test; A single dose of LY3437943 administered by subcutaneous (SC) injection via a test device (test formulation)	Drug: LY3437943; Administered SC; Device: Test; Used to administer LY3437943 SC
Active Comparator: LY3437943 - Reference; A single dose of LY3437943 administered by SC injection via a reference device (reference formulation)	Drug: LY3437943; Administered SC; Device: Reference; Used to administer LY3437943 SC

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2023
• Primary Completion (Actual): February 8, 2024
• Study Completion (Actual): February 8, 2024

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 18530; J1I-MC-GZBX (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes