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NCT05440344 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy and Hepatic Insufficiency, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target
3
Study locations

NCT05440344: Completed Phase 1 study of Healthy and Hepatic Insufficiency, sponsored by Eli Lilly and Company.

NCT05440344 is a Phase 1 study of Healthy and Hepatic Insufficiency that has completed, run by Eli Lilly and Company. The registered enrollment target is 27 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05440344, a Phase 1 study of Healthy and Hepatic Insufficiency, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target
3
Study locations

Study 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.

Primary Outcome

PK: Cmax of Imlunestrant is reported.

Interventions

  • DRUG Imlunestrant

Study Locations (3)

California

  • Inland Empire Liver Foundation - Rialto

Florida

  • Orlando Clinical Research Center - Orlando

Texas

  • American Research Corporation at Texas Liver Institute - San Antonio

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2022-07-05
Est. Completion 2024-02-28
Phase Phase 1
Eli Lilly and Company

1,341 total trials

What the finished NCT05440344 record still lists

NCT05440344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).

The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Imlunestrant is the first listed.

NCT05440344 reports a single indexed study location in California, Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT05440344 about?

NCT05440344 is a clinical study titled "A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function". 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...

What is the current status of trial NCT05440344?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2022-07-05. Estimated completion is 2024-02-28.

What conditions does trial NCT05440344 study?

This clinical trial studies the following conditions: Healthy, Hepatic Insufficiency.

What interventions are being tested in trial NCT05440344?

The interventions under investigation include: Imlunestrant (DRUG).

Who is sponsoring clinical trial NCT05440344?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05440344 being conducted?

This trial has 3 study locations across California, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05440344's enrollment target sits among peer trials

27 752nd of 1090 higher than 332 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05440344, the US trial registry maintained by the National Library of Medicine. NCT05440344 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.