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cholestatic liver disease

Total Trials
3
Recruiting Now
3
Trial Phases
Phase 1

Liver disease clinical trials span a spectrum from non-alcoholic steatohepatitis (MASH/NASH) β€” where the FDA approved resmetirom in 2024 in a landmark first β€” to alcoholic hepatitis, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis, and hepatocellular carcinoma. MASH has become one of the most active areas in all of clinical medicine, driven by its rising global prevalence, progression to cirrhosis, and the now-validated principle that histological improvement is achievable.

Active MASH trials investigate THR-Ξ² agonists (resmetirom, MGL-3196), GLP-1/FGF21 combinations, FXR agonists, Pan-PPAR agonists (lanifibranor), and multi-target approaches combining metabolic and anti-fibrotic mechanisms. Hepatocellular carcinoma trials test atezolizumab plus bevacizumab combinations, lenvatinib plus pembrolizumab, and novel VEGF bispecifics. Liver fibrosis biomarkers (FIB-4, MRE-determined liver stiffness) are standard enrollment and response tools.

MASH trials typically require biopsy-confirmed NASH with fibrosis stage F1–F3 and NAS ≥4; end-stage liver disease (Child-Pugh C) is often an exclusion criterion.

Frequently Asked Questions — cholestatic liver disease Clinical Trials

How many clinical trials are currently recruiting for cholestatic liver disease?
ClinicalMetric currently tracks 3 actively recruiting clinical trials for cholestatic liver disease, sourced in real time from ClinicalTrials.gov. The total number of registered studies—including those not yet enrolling or in active follow-up—is 3. Trial availability changes daily as new studies open enrollment and existing ones reach capacity.
What trial phases are available for cholestatic liver disease?
cholestatic liver disease research spans Phase 1 (1 trial). Phase 1 studies evaluate safety and dosing in small groups, Phase 2 studies assess preliminary efficacy in 100–300 participants, and Phase 3 trials compare the new treatment against the standard of care in 300–3,000+ patients. Phase 4 post-approval studies monitor long-term outcomes in real-world populations.
How do I find out if I qualify for a cholestatic liver disease clinical trial?
Eligibility criteria for cholestatic liver disease trials vary by study and typically specify age range, disease stage or severity, prior treatment history, and specific diagnostic or laboratory parameters. Each listing on ClinicalMetric links to the full protocol on ClinicalTrials.gov, where inclusion and exclusion criteria are documented. Contact the sponsoring site's research coordinator directly to confirm your eligibility—your treating physician or specialist can also help identify the most appropriate trial based on your medical history and current treatment status.
Trial Phases
Phase 1
1
Top Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna 2 trials
Zydus Therapeutics Inc. 1 trial

Recruiting Clinical Trials

NCT06781242
Recruiting

Genotype-phenotype Relationship Between Cryptogenic Cholestasis and Familial Intrahepatic Cholestasis

Enrollment
300 pts
Location
Italy
Sponsor
IRCCS Azienda Ospedaliero-Univ...
View Trial →
NCT06825559 Phase 1
Recruiting

Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease

Enrollment
6 pts
Location
United States
Sponsor
Zydus Therapeutics Inc.
View Trial →
NCT06777914
Recruiting

Familial Intrahepatic Cholestasis-related Genes Associated with Disease Susceptibility in Hepato-biliary Cancers

Enrollment
600 pts
Location
Italy
Sponsor
IRCCS Azienda Ospedaliero-Univ...
View Trial →
ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology