Hepatic InsufficiencyPhase 1NCT05440344

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

A Phase 1 study testing Imlunestrant in people with Hepatic Insufficiency and Healthy, run by Eli Lilly and Company at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Hepatic Insufficiency, Healthy
What is being tested?: Imlunestrant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 3 sitesUnited States
Study dates: 5 Jul 2022to 28 Feb 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Orlando Clinical Research Center
Orlando, Florida, 32809
Inland Empire Liver Foundation
Rialto, California, 92377
American Research Corporation at Texas Liver Institute
San Antonio, Texas, 78215

Other trials in United States

About this study

Official title: Pharmacokinetics of Imlunestrant in Participants With Hepatic Impairment

Conditions: Hepatic Insufficiency, Healthy
Being tested: Imlunestrant
Medical subject headings: Hepatic Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ImlunestrantDrug
Also called LY3484356
Administered orally.

Study groups in NCT05440344
Study group	Role	What they receive
Imlunestrant (Normal Hepatic Function)	Experimental	Participants received a single dose of Imlunestrant 400 milligrams (mg) administered orally on Day 1 in fasted state. Receives: Drug: Imlunestrant
Imlunestrant (Mild Hepatic Impairment)	Experimental	Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state. Receives: Drug: Imlunestrant
Imlunestrant (Moderate Hepatic Impairment)	Experimental	Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state. Receives: Drug: Imlunestrant
Imlunestrant (Severe Hepatic Impairment)	Experimental	Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state. Receives: Drug: Imlunestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant
PK: Cmax of Imlunestrant is reported.
Measured: 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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jul 202228 Feb 2024

First posted30 Jun 2022
Study start5 Jul 2022
Primary completion28 Feb 2024
Study completion28 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05440344
Sponsor's protocol ID: 18414
Other IDs: J2J-MC-JZLG
Status last verified: Oct 2025
First submitted: 27 Jun 2022
Last updated: 12 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
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RecruitingObservational study
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All Hepatic Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of Imlunestrant in Participants With Hepatic Impairment
ClinicalTrials.gov ID: NCT05440344
Acronym / sponsor ID: 18414
Conditions: Hepatic Insufficiency, Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 5 Jul 2022 (actual)
Primary completion: 28 Feb 2024 (actual)
Study completion: 28 Feb 2024 (actual)
First posted: 30 Jun 2022 (actual)
Results: Posted 12 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Imlunestrant (Normal Hepatic Function)	Experimental	Drug: ImlunestrantParticipants received a single dose of Imlunestrant 400 milligrams (mg) administered orally on Day 1 in fasted state.
Imlunestrant (Mild Hepatic Impairment)	Experimental	Drug: ImlunestrantParticipants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
Imlunestrant (Moderate Hepatic Impairment)	Experimental	Drug: ImlunestrantParticipants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
Imlunestrant (Severe Hepatic Impairment)	Experimental	Drug: ImlunestrantParticipants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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 females as determined by medical history, physical examination, and other screening procedures, with normal 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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ImlunestrantAlso: LY3484356Administered orally.	Drug	Imlunestrant (Mild Hepatic Impairment), Imlunestrant (Moderate Hepatic Impairment), Imlunestrant (Normal Hepatic Function), Imlunestrant (Severe Hepatic Impairment)

Primary outcome

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant
Time frame: 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: Cmax of Imlunestrant is reported.
PK: Area Under the Concentration-time Curve From 0 to the Last Measurable Concentration (AUC[0-t]) of Imlunestrant
Time frame: 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)
AUC(0-t) of Imlunestrant is reported.

Results and safety

Results posted to the registry on 12 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Imlunestrant (Normal Hepatic Function)	9	9
Imlunestrant (Mild Hepatic Impairment)	6	6
Imlunestrant (Moderate Hepatic Impairment)	6	6
Imlunestrant (Severe Hepatic Impairment)	6	6

Primary outcome: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant

Time frame: 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). Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	Imlunestrant (Normal Hepatic Function) n = 9	Imlunestrant (Mild Hepatic Impairment) n = 6	Imlunestrant (Moderate Hepatic Impairment) n = 6	Imlunestrant (Severe Hepatic Impairment) n = 6
Value	58.0 (56)	74.9 (47)	87.6 (51)	46.2 (49)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

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

Measure	Imlunestrant (Normal Hepatic Function) n = 9	Imlunestrant (Mild Hepatic Impairment) n = 6	Imlunestrant (Moderate Hepatic Impairment) n = 6	Imlunestrant (Severe Hepatic Impairment) n = 6
Value	1970 (51)	2410 (27)	4320 (50)	2820 (47)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Adverse events

Time frame: Baseline up to 18 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Imlunestrant (Normal Hepatic Function)	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Imlunestrant (Mild Hepatic Impairment)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Imlunestrant (Moderate Hepatic Impairment)	1 of 6 (16.7%)	2 of 6 (33.3%)	0 of 6
Imlunestrant (Severe Hepatic Impairment)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver FunctionLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Hepatic Insufficiency

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Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Imlunestrant in people with Hepatic Insufficiency and Healthy, run by Eli Lilly and Company at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05440344.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.