Hepatic Impairment: Clinical Trials

224 completed, 13 recruiting, 12 unknown, 8 terminated. 258 Phase 1, 3 Phase 4, 2 Not applicable, 2 Phase 2.

By phase and status

Phase	Trials	Status
Phase 1	258	Completed 217, Recruiting 13, Unknown 10, Terminated 8, Not yet recruiting 5, Withdrawn 5
Phase 4	3	Completed 2, Withdrawn 1
Not applicable	2	Completed 2
Phase 2	2	Completed 1, Unknown 1

Follow Hepatic Impairment: new trials by email Literature Review of Hepatic Impairment trials Research Report on Hepatic Impairment

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment Tacabrutideg - Hepatic Impairment, Healthy Adult Participants	Phase 1	Not yet recruiting	BeOne Medicines	24	2026-12-01	2026-11-04
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment Sonrotoclax - Hepatic Impairment, Healthy Adult Participants	Phase 1	Not yet recruiting	BeOne Medicines	12	2026-11-01	2026-10-20
Aleniglipron Hepatic Impairment Study Aleniglipron - Hepatic Impairment	Phase 1	Not yet recruiting	Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics	36	2026-10-01	2026-10-21
A Phase I Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD4144 AZD4144 - Hepatic Impairment	Phase 1	Not yet recruiting	AstraZeneca	30	2026-08-24	2026-08-24
Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function Casdatifan - Healthy Participants, Hepatic Impairment	Phase 1	Recruiting	Arcus Biosciences, Inc.	16	2026-08-14	2026-09-04
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment Treprostinil Palmitil Inhalation Powder - Hepatic Impairment	Phase 1	Recruiting	Insmed Incorporated	30	2026-07-14	2026-11-09
A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease Atirmociclib - Hepatic Impairment, Healthy, Hepatic Insufficiency	Phase 1	Recruiting	Pfizer	28	2026-06-29	2026-08-21
A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems BI 3000202 - Healthy, Hepatic Impairment	Phase 1	Completed	Boehringer Ingelheim	34	2026-05-01	2026-11-12
MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function Midomafetamine HCl - Pharmacokinetics, Hepatic Impairment	Phase 1	Not yet recruiting	Resilient Pharmaceuticals	16	2026-03-29	2024-10-30
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234 AZD6234, AZD9550 - Hepatic Impairment	Phase 1	Recruiting	AstraZeneca	28	2026-03-20	2026-10-22
Radiprodil in Participants With Hepatic Impairment Radiprodil - Hepatic Impairment	Phase 1	Recruiting	GRIN Therapeutics, Inc.	40	2026-03-03	2026-05-08
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function PF-07328948 - Hepatic Impairment, Healthy	Phase 1	Recruiting	Pfizer	26	2025-12-22	2026-07-23
A Study to Assess the Drug Levels and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Different Degrees of Hepatic Impairment BMS-986435 - Healthy Volunteers, Hepatic Impairment	Phase 1	Completed	Bristol-Myers Squibb	69	2025-12-15	2026-09-21
A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) Calderasib - Healthy, Hepatic Impairment	Phase 1	Completed	Merck Sharp & Dohme LLC	32	2025-11-05	2026-08-04
A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015) MK-8527 - Hepatic Impairment, Healthy Participants	Phase 1	Completed	Merck Sharp & Dohme LLC	18	2025-09-19	2026-02-27
Phase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy Controls BPN14770 - Hepatic Impairment	Phase 1	Completed	Shionogi	32	2025-08-30	2026-02-27
A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib Inavolisib - Hepatic Impairment	Phase 1	Completed	Genentech, Inc.	27	2025-08-21	2026-10-23
A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems BI 1291583 - Healthy, Hepatic Impairment	Phase 1	Recruiting	Boehringer Ingelheim	32	2025-07-17	2026-10-13
Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function ITF2357 - Hepatic Impairment	Phase 1	Completed	Italfarmaco	24	2025-05-29	2026-06-18
Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI) Zanzalintinib - Hepatic Impairment, Moderate Hepatic Impairment	Phase 1	Recruiting	Exelixis	20	2025-05-13	2025-06-22

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Narrower conditions

Liver Diseases (15)  ·  Lymphoma, Follicular (9)  ·  Hepatic Insufficiency (5)  ·  Non-alcoholic Fatty Liver Disease (5)  ·  Liver Cirrhosis (4)  ·  Renal Insufficiency (4)  ·  Fibrosis (3)  ·  HIV Infections (3)  ·  Hepatitis C (3)  ·  Acquired Immunodeficiency Syndrome (2)  ·  Hematologic Neoplasms (2)  ·  Liver Failure (2)  ·  Neoplasms (2)  ·  Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (1)  ·  Atrial Fibrillation (1)

Broader conditions

Digestive System Diseases (32)  ·  Liver Diseases (18)  ·  Neoplasms (15)  ·  Pathological Conditions, Signs and Symptoms (14)  ·  Immune System Diseases (13)  ·  Pathologic Processes (12)  ·  Hemic and Lymphatic Diseases (11)  ·  Neoplasms by Histologic Type (11)  ·  Urogenital Diseases (10)  ·  Immunoproliferative Disorders (9)  ·  Lymphatic Diseases (9)  ·  Lymphoma (9)  ·  Lymphoma, Non-Hodgkin (9)  ·  Lymphoproliferative Disorders (9)  ·  Female Urogenital Diseases (7)

Interventions

dolutegravir (3)  ·  AT-511 (2)  ·  Ritonavir (2)  ·  ZD4054 (2)  ·  binimetinib (2)  ·  enasidenib (2)  ·  fedratinib (2)  ·  quizartinib (2)  ·  saroglitazar (2)  ·  seladelpar (2)  ·  telotristat (2)  ·  (2-methyl-4-(5-methyl-2-(4-trifluoromethyl-phenyl)-2H-(1,2,3)triazol-4-ylmethylsulfanyl)phenoxy)acetic acid (1)  ·  (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol (1)  ·  1-(3-(2-(1-benzothiophen-5-yl) ethoxy) propyl)-3-azetidinol maleate (1)  ·  2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid (1)

Sponsors

Novartis Pharmaceuticals (23)  ·  AstraZeneca (14)  ·  Pfizer (13)  ·  Janssen Research & Development, LLC (10)  ·  Bristol-Myers Squibb (8)  ·  Merck Sharp & Dohme LLC (8)  ·  Celgene (6)  ·  Jiangsu HengRui Medicine Co., Ltd. (6)  ·  Amgen (5)  ·  Takeda (5)  ·  Daiichi Sankyo (4)  ·  AbbVie (3)  ·  Astellas Pharma Global Development, Inc. (3)  ·  Biogen (3)  ·  Eisai Inc. (3)

Countries

United States (182)  ·  Germany (25)  ·  China (18)  ·  Slovakia (13)  ·  Czechia (10)  ·  Hungary (8)  ·  Bulgaria (6)  ·  Poland (6)  ·  Russia (6)  ·  Belgium (5)  ·  South Korea (4)  ·  Spain (4)  ·  France (3)  ·  Italy (3)  ·  Japan (3)

Results publications

PMID 10874271, PMID 14677737, PMID 15155313, PMID 18304122, PMID 21414193, PMID 23197081, PMID 24084213, PMID 24374856, PMID 25136024, PMID 25511105, PMID 25603822, PMID 25633714, PMID 25975934, PMID 26405017, PMID 26519231, PMID 27267254, PMID 27570245, PMID 27645244, PMID 27743502, PMID 28365033, PMID 28430430, PMID 29026685, PMID 30052269, PMID 30194585, PMID 30224193, PMID 30704966, PMID 31632000, PMID 32304015, PMID 32648303, PMID 32800532, PMID 33356019, PMID 33749838, PMID 33813736, PMID 34002356, PMID 34046915, PMID 34115385, PMID 34246461, PMID 34324028, PMID 35061234, PMID 36217101, PMID 36352054, PMID 36471222, PMID 36786053, PMID 36977960, PMID 37070852, PMID 37801266, PMID 37917289, PMID 38993026, PMID 39287964, PMID 39358661

NIH funding

2019 (5), 2015 (2), 2017 (2), 2018 (2), 2016 (1), 2023 (1)