A Study of LY3437943 in Participants With Impaired and Normal Liver Function

NCT05916560 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18531J1I-MC-GZBT
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 5

Brief Summary

The main purpose of this study is to measure how much of LY3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to healthy participants with normal liver function. The safety and tolerability of LY3437943 will also be evaluated. The study may last up to 9 weeks for each participant including the screening period.

Conditions

Healthy; Hepatic Insufficiency

Keywords

Pharmacokinetics; Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943

  PK: AUC0-∞ of LY3437943

  Predose up to 30 days postdose

• PK: Maximum observed concentration (Cmax) of LY3437943

  PK: Cmax of LY3437943

  Predose up to 30 days postdose

Study Arms (4)

LY3437943 (Normal Hepatic Function)

EXPERIMENTAL

LY3437943 administered subcutaneously (SC).

Drug: LY3437943

LY3437943 (Severe Hepatic Impairment)

EXPERIMENTAL

LY3437943 administered SC.

Drug: LY3437943

LY3437943 (Moderate Hepatic Impairment)

EXPERIMENTAL

LY3437943 administered SC.

Drug: LY3437943

LY3437943 (Mild Hepatic Impairment)

EXPERIMENTAL

LY3437943 administered SC.

Drug: LY3437943

Interventions

LY3437943 DRUG

Administered SC.

LY3437943 (Mild Hepatic Impairment); LY3437943 (Moderate Hepatic Impairment); LY3437943 (Normal Hepatic Function); LY3437943 (Severe Hepatic Impairment)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Participants:
• Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive
• Healthy or various degrees of hepatic impairment depending on the study group

You may not qualify if:

• Participants with hepatic impairment:
• Have or are anticipating an organ transplant within the next 6 months
• Requires needle evacuation of ascites fluid more than 2 times per month
• Have had variceal bleeding within 3 months of check-in, unless the participant has undergone a successful banding procedure; in that case, may check-in from 1 month after the banding procedure

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

Arizona Clinical Trials - Chandler

Chandler, Arizona, 85225, United States

Location

Accel Research Sites- Clinical Research Unit

DeLand, Florida, 32720, United States

Location

Advanced Pharma Clinical Research

Miami, Florida, 33147-4040, United States

Location

American Research Corporation at Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Pinnacle Clinical Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

retatrutide

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

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: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 23, 2023
• Study Start: July 13, 2023
• Primary Completion: March 2, 2025
• Study Completion: March 2, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)