A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function

NCT05440344 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 18414J2J-MC-JZLG
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

The main purpose of this study is to measure how much of Imlunestrant (LY3484356) gets into the bloodstream and how long it takes the body to eliminate it in female participants with impaired liver function compared to female participants with normal liver function. The side effects and tolerability of Imlunestrant will also be evaluated. The study may last up to 46 days for each participant.

Conditions

Hepatic Insufficiency; Healthy

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant

  PK: Cmax of Imlunestrant is reported.

  Day 1 (Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post dose)

• PK: Area Under the Concentration-time Curve From 0 to the Last Measurable Concentration (AUC[0-t]) of Imlunestrant

  AUC(0-t) of Imlunestrant is reported.

  Day 1 (Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post dose)

Study Arms (4)

Imlunestrant (Normal Hepatic Function)

EXPERIMENTAL

Participants received a single dose of Imlunestrant 400 milligrams (mg) administered orally on Day 1 in fasted state.

Drug: Imlunestrant

Imlunestrant (Mild Hepatic Impairment)

EXPERIMENTAL

Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.

Drug: Imlunestrant

Imlunestrant (Moderate Hepatic Impairment)

EXPERIMENTAL

Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.

Drug: Imlunestrant

Imlunestrant (Severe Hepatic Impairment)

EXPERIMENTAL

Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state.

Drug: Imlunestrant

Interventions

Imlunestrant DRUG

Administered orally.

Also known as: LY3484356

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

Eligibility Criteria

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

You may qualify if:

• All Participants:
• Women not of childbearing potential may participate and include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy or tubal ligation), congenital anomaly such as mullerian agenesis; or postmenopausal
• Are between the body mass index (BMI) of 18.0 and 42.0 kilograms per meter squared (kg/m²), inclusive, at screening
• Healthy Participants:
• \- Healthy females as determined by medical history, physical examination, and other screening procedures, with normal liver function
• Participants with Impaired Liver Function:
• Females with chronic mild, moderate and severe liver impairment, assessed by Child-Pugh scoring
• Have diagnosis of chronic hepatic impairment (\>6 months), with no clinically significant changes within 90 days prior to study drug administration.

You may not qualify if:

• Women of childbearing potential are excluded from the study.
• Have known allergies to imlunestrant or related compounds
• Have a history of alcoholism or drug/chemical abuse within 2 years prior to check-in
• Have received blood products within 2 months prior to check-in
• Have evidence of HIV infection and/or positive human HIV antibodies
• Have used or intend to use medications that are strong inhibiters or inducers of cytochrome P450 (CYP)3A4
• Who smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e-cigarettes (nicotine and non-nicotine) per day.
• Have a history or presence of cardiovascular (eg, symptomatic bradycardia with resting heart rate of \<60 beats per minute), respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Inland Empire Liver Foundation

Rialto, California, 92377, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

American Research Corporation at Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Related Links

• A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

Imlunestrant

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

08005455979

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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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 27, 2022
• First Posted: June 30, 2022
• Study Start: July 5, 2022
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)