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

NCT06003465 | Completed Phase 1 FDA Drug FDA Device

• 2 other identifiers: 18530J1I-MC-GZBX
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

LY3437943 - Test

EXPERIMENTAL

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

Drug: LY3437943; Device: Test

LY3437943 - Reference

ACTIVE COMPARATOR

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

Drug: LY3437943; Device: Reference

Interventions

LY3437943 DRUG

Administered SC

LY3437943 - Reference; LY3437943 - Test

Test DEVICE

Used to administer LY3437943 SC

LY3437943 - Test

Reference DEVICE

Used to administer LY3437943 SC

LY3437943 - Reference

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Qps-Mra, Llc

Miami, Florida, 33143-4875, United States

Location

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

ICON

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

retatrutide

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 22, 2023
• Study Start: August 29, 2023
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)