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A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis

A Proof of Concept, Prospective, Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients With Primary Sclerosing Cholangitis

NCT06095986•Galmed Pharmaceuticals Ltd

View on ClinicalTrials.gov

Summary

The objectives of this study is to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients with Primary Sclerosing Cholangitis

Detailed Description

The objectives of this study are to: * Establish the safety and tolerability of once daily (QD) Aramchol meglumine in patients with PSC * Examine whether once daily (QD) Aramchol meglumine has any effect on serum alkaline phosphatase * Provide a comprehensive readout of clinical efficacy following once daily (QD) Aramchol meglumine administration

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female age 18 years and above (inclusive at first screening visit)
•2. Established diagnosis of large duct PSC based on abnormal cholangiography as assessed by magnetic resonance cholangiopancreatography (MRCP) or Endoscopic retrograde cholangiopancreatography (ERCP)
•3. Alkaline phosphatase \> 150 IU/l
•4. Stable inflammatory bowel disease therapy \> 3months for IBD patients
•5. If receiving treatment with Ursodeoxycholic acid (UDCA; ursodiol), therapy is at a dose of \<20 mg/kg/day, has been stable for at least 6 months before screening
•6. Ability to understand the nature of the study and to sign a written informed consent form (ICF)

Exclusion Criteria

•1. Other causes of liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically
•2. Active Crohn's disease (CDAI \> 40) or ulcerative colitis (Mayo IBD score \> 4) or active non-hemorrhoidal rectal bleeding
•3. Small bowel resection \> 100 cm
•4. Cirrhosis (clinically evident or by biopsy)
•5. Prior hepatic decompensation event
•6. Recent (\< 6 weeks) acute cholangitis or hospitalization for PSC or IBD
•7. Bleeding diathesis or other contraindication for liver biopsy
•8. Known GI or hepatobiliary malignancy
•9. Prior liver transplantation
•10. Prior exposure to study drug
+1 more criteria

Locations (1)

The Sanyal Institute for Liver Disease & Metabolic Health at VCU

Richmond, Virginia, United States

Key Dates

Start Date

June 1, 2025

Primary Completion Date

September 1, 2026

Completion Date

December 1, 2027

Last Updated

June 12, 2025

Conditions

Primary Sclerosing Cholangitis

Interventions

Aramchol meglumine

DRUG

Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients

NCT04753996

Primary Sclerosing CholangitisPSC+1 more

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RECRUITING

A-LiNK: Improving Outcomes in Autoimmune Liver Disease

NCT05750498

Autoimmune HepatitisPrimary Sclerosing Cholangitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis

Inclusion Criteria

Exclusion Criteria

Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients

A-LiNK: Improving Outcomes in Autoimmune Liver Disease

Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

Liver Cirrhosis Network Cohort Study

S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)

Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)