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Hepatic impairment

Part of Liver disease

2 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for hepatic impairment

42 trials tracked for hepatic impairment: 2 in phase 3 or 4 and 1 with published results. The most-cited published study has 36 citations.

42Trials tracked

2Phase 3 & 4

0Recruiting

1With published results

Phase distribution

Phase 4 2 Phase 2 1 Phase 1 39

Phase 4 Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects Completed · 36 cited
Phase 4 An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild and Moderate Hepatic Insufficiency and Healthy Volunteers Completed
Phase 2 A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers Completed
Phase 1 Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014) Completed
Phase 1 PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers Completed
Phase 1 A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014) Completed

Show 36 more trials

Phase 1 Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib Completed
Phase 1 A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers Completed
Phase 1 A Study to Investigate the Influence of Hepatic Impairment on Elpipodect (MK-8189) Treatment (MK-8189-012) Completed
Phase 1 A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants. Completed
Phase 1 Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment Completed
Phase 1 An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) Completed
Phase 1 Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects Completed
Phase 1 Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite Completed
Phase 1 Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment Completed
Phase 1 Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects Completed
Phase 1 Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function Completed
Phase 1 A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction Completed
Phase 1 A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function Completed
Phase 1 A Study to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics (PK) of Intravenous TAK-954 Completed
Phase 1 Effect of Hepatic Impairment on M2951 (BTK Inhibitor) PK Completed
Phase 1 Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment Completed
Phase 1 Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects Completed
Phase 1 Phase I Open-label Study to Evaluate Pharmacokinetics of TAK-272 in Participants With Renal or Hepatic Impairment Completed
Phase 1 A Phase 1 Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function Completed
Phase 1 Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment Completed
Phase 1 Study of Nalbuphine ER in Participants With Hepatic Impairment Completed
Phase 1 A Study of Effects of Selpercatinib in Hepatically Impaired Participants and Healthy Participants Completed
Phase 1 Tepotinib Hepatic Impairment Trial Completed
Phase 1 Pharmacokinetics of BAF312 in Patients With Hepatic Impairment Completed
Phase 1 Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment Completed
Phase 1 Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients Completed
Phase 1 A Study to Evaluate Molnupiravir (MK-4482) in Participants With Moderate Hepatic Impairment (MK-4482-016) Completed
Phase 1 STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT Completed
Phase 1 A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT Completed
Phase 1 Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332 Completed
Phase 1 Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function Completed
Phase 1 A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function Completed
Phase 1 A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030) Completed
Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, and PK of Aramchol in Subjects With Hepatic Impairment Completed
Phase 1 A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment Completed
Phase 1 A Hepatic Impairment Study for PF-04965842. Completed

Showing the 42 most-cited and recently-updated of 42 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Hepatic impairment: what the trials found

In patients with hepatic impairment, established evidence from phase 4 trials shows that 2.0 mg buprenorphine/0.5 mg naloxone ⁵ and Ferriprox® ⁶ have been studied, but no specific outcome data are provided in these trials.

Recent phase 1 trials provide new safety data for several agents in hepatic impairment. For seladelpar, treatment-emergent adverse events (TEAEs) and study drug-related TEAEs were reported in 0% to 40% of participants across hepatic function groups, with grade 3 or 4 TEAEs in 0% to 40% and TEAEs of special interest in 0% to 20% ². For bulevirtide, TEAEs occurred in 9.1% to 27.3% of participants, and laboratory abnormalities in 62.5% to 100% ⁴. For M2951, changes from baseline in prothrombin international normalized ratio ranged from -0.029 to 0.021 ⁸.

Several other phase 1 trials have been conducted in hepatic impairment with agents including enlicitide ¹, nalbuphine ER ³, efinopegdutide ⁹, and others, but no outcome data are available from these trials.

Recent results — preliminary, needs further review

Seladelpar: TEAEs and drug-related TEAEs ranged from 0% to 40% across hepatic function groups; grade 3 or 4 TEAEs 0% to 40%; TEAEs of special interest 0% to 20% ².
Bulevirtide: TEAEs 9.1% to 27.3%; laboratory abnormalities 62.5% to 100% ⁴.
M2951: Change in prothrombin INR from baseline ranged from -0.029 to 0.021 ⁸.
Enlicitide, nalbuphine ER, and efinopegdutide have been studied but no outcome data reported ¹³⁹.

For the clinician treating this condition

In hepatic impairment, recent phase 1 trials of seladelpar and bulevirtide show variable rates of TEAEs and laboratory abnormalities, suggesting the need for monitoring.
For M2951, minimal changes in prothrombin INR were observed, indicating limited impact on coagulation in this population.
Many newer agents (e.g., enlicitide, nalbuphine ER, efinopegdutide) lack published safety data in hepatic impairment, highlighting the need for further study.

AI synthesis of 8 cited trials, updated Jun 26, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.