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2026 data Public-data reference. official source

Hepatic Impairment

Open-data reference.

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49 US clinical trials · 13 currently recruiting

Active & Recent Trials

RECRUITING Phase 1 144 participants

Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434

Vir Biotechnology

NCT05484206
RECRUITING Phase 1 58 participants

A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)

Merck Sharp & Dohme

NCT07219550
RECRUITING Phase 1 48 participants

An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage

Alumis

NCT06952634
RECRUITING Phase 1 40 participants

Phase 1 Open-Label Study of Radiprodil Pharmacokinetics, Safety, and Tolerability in Hepatically Impaired Participants

GRIN Therapeutics

NCT07457229
RECRUITING Phase 1 32 participants

A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems

Boehringer Ingelheim

NCT07023354
RECRUITING Phase 1 32 participants

Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib

SpringWorks Therapeutics

NCT06997276
RECRUITING Phase 1 32 participants

A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib

Genentech

NCT07144111
RECRUITING Phase 1 30 participants

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

Zydus Therapeutics

NCT05045482
RECRUITING Phase 1 28 participants

Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function

Atea Pharmaceuticals

NCT06911320
RECRUITING Phase 1 26 participants

A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function

Pfizer

NCT07269301
RECRUITING Phase 1 24 participants

A Study to Compare the Blood Levels and Safety of Tazemetostat in Participants With Advanced Cancer and Moderate/Severe Liver Impairment to Participants With Advanced Cancer and Normal Liver Function

Epizyme

NCT04241835
RECRUITING Phase 1 20 participants

Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)

Exelixis

NCT06962332
RECRUITING Phase 1 12 participants

Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

Daiichi Sankyo

NCT06740799
COMPLETED Phase 1 118 participants

A Study to Evaluate the Pharmacokinetics of AFQ056 in Subjects With Hepatic Impairment Compared to Healthy Subjects

Novartis Pharmaceuticals

NCT01456663
COMPLETED Phase 1 98 participants

Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function

Zydus Therapeutics

NCT04469920
COMPLETED Phase 1 87 participants

Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects

Madrigal Pharmaceuticals

NCT04643795
COMPLETED Phase 1 74 participants

Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function

Gilead Sciences

NCT05765344
COMPLETED Phase 1 39 participants

Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function

Atea Pharmaceuticals

NCT05724693
COMPLETED Phase 1 38 participants

A Single-dose, Open-label, Pharmacokinetic Study of Belapectin (GR-MD-02) in Subjects With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment

Galectin Therapeutics

NCT04332432
COMPLETED Phase 1 38 participants

Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment

Novartis Pharmaceuticals

NCT05599932
COMPLETED Phase 1 36 participants

A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function

Takeda

NCT05098054
COMPLETED Phase 1 32 participants

Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients

Jazz Pharmaceuticals

NCT01887301
COMPLETED Phase 1 32 participants

Pharmacokinetics of AGO178 in Participants With Liver Impairment

Novartis Pharmaceuticals

NCT01531309
COMPLETED Phase 1 32 participants

The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist

Portola Pharmaceuticals

NCT03397888
COMPLETED Phase 1 32 participants

A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects

Novartis Pharmaceuticals

NCT02857868
COMPLETED Phase 1 31 participants

A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.

Celgene

NCT03290443
COMPLETED Phase 1 30 participants

A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment

Insmed Incorporated

NCT05517525
COMPLETED Phase 1 30 participants

A Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Relacorilant

Corcept Therapeutics

NCT06094725
COMPLETED Phase 1 30 participants

Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients

Genfit

NCT03765671
COMPLETED Phase 1 30 participants

Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone

AstraZeneca

NCT06388616
COMPLETED Phase 1 29 participants

Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment

Vanda Pharmaceuticals

NCT01271387
COMPLETED Phase 1 28 participants

Study of Single-dose DS-3201b in Participants With Hepatic Impairment

Daiichi Sankyo

NCT04276662
COMPLETED Phase 1 28 participants

A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.

Basilea Pharmaceutica

NCT05582187
COMPLETED Phase 1 25 participants

A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants

Shionogi

NCT05409911
COMPLETED Phase 1 25 participants

A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment

Amgen

NCT05481411
COMPLETED Phase 1 24 participants

A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function

Akebia Therapeutics

NCT03799848
COMPLETED Phase 1 24 participants

A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants With Mild or Moderate Hepatic Impairment

Amgen

NCT06004934
COMPLETED Phase 1 24 participants

A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction

Pfizer

NCT05478603
COMPLETED Phase 1 24 participants

Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects

Eisai

NCT03440424
COMPLETED Phase 1 24 participants

Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects

Pfizer

NCT04091061
COMPLETED Phase 1 21 participants

Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment

Bristol-Myers Squibb

NCT00162097
COMPLETED Phase 1 20 participants

Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment

Amgen

NCT04887064
COMPLETED Phase 1 18 participants

Tepotinib Hepatic Impairment Trial

EMD Serono Research & Development Institute

NCT03546608
COMPLETED Phase 1 18 participants

PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function

NewAmsterdam Pharma

NCT06048302
COMPLETED Phase 1 18 participants

A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function

Janssen Research & Development

NCT04154774
COMPLETED Phase 1 17 participants

Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332

Pfizer

NCT05005312
COMPLETED Phase 1 16 participants

A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function

Institut de Recherches Internationales Servier

NCT05674474
COMPLETED Phase 1 16 participants

Surufatinib Hepatic Impairment Study

Hutchison Medipharma Limited

NCT04755075
COMPLETED Phase 1 16 participants

Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment

Mylan

NCT02581592

Phase Distribution

PhaseTrial count
Early Phase 1 49

Top Sponsors

Pfizer 4 trials
Novartis Pharmaceuticals 4 trials
Amgen 3 trials
Daiichi Sankyo 2 trials
Atea Pharmaceuticals 2 trials
Zydus Therapeutics 2 trials
Galectin Therapeutics 1 trials
Hutchison Medipharma Limited 1 trials
Mylan 1 trials
Portola Pharmaceuticals 1 trials

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Hepatic Impairment Trial Landscape

ClinicalTrials.gov lists 49 US studies indexed under Hepatic Impairment, and 13 of those are currently open to recruitment — roughly 27% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

The phase distribution for Hepatic Impairment shows 0 late-stage studies (Phase 3 and Phase 4 combined) alongside 49 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

Top sponsor activity for Hepatic Impairment is led by Pfizer with 4 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 49 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Hepatic Impairment?

PlainTrial tracks 49 US clinical trials for Hepatic Impairment, of which 13 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Hepatic Impairment?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

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Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Read our methodology — how this data is sourced, computed, and verified.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2024 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

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