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

NCT06095986 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: AM-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in serum alkaline phosphatase (ALP)

  The change from Baseline to Week 48 in ALP levels

  48 weeks

Secondary Outcomes (10)

• Change from Baseline in hepatobiliary fibrosis using the Nakanuma staging scale

  48 weeks

• Change from Baseline in Enhanced liver fibrosis (ELF)

  48 weeks

• Change from Baseline in MRCP

  48 weeks

• Change from Baseline in quantitative liver function using Gadoxetate clearance

  48 weeks

• Change from Baseline in 5D-itch scale

  48 weeks

Study Arms (2)

PSC patients administered with Aramchol meglumine

ACTIVE COMPARATOR

Adult subjects with clinically diagnosed PSC that are administered with Aramchol meglumine

Drug: Aramchol meglumine

PSC patients administered with placebo

PLACEBO COMPARATOR

Adult subjects with clinically diagnosed PSC that are administered with matching placebo

Drug: Aramchol meglumine

Interventions

Aramchol meglumine DRUG

Aramchol meglumine is derived from a weak acid (Aramchol) and an amino-sugar (meglumine)

PSC patients administered with Aramchol meglumine; PSC patients administered with placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 18 years and above (inclusive at first screening visit)
• Established diagnosis of large duct PSC based on abnormal cholangiography as assessed by magnetic resonance cholangiopancreatography (MRCP) or Endoscopic retrograde cholangiopancreatography (ERCP)
• Alkaline phosphatase \> 150 IU/l
• Stable inflammatory bowel disease therapy \> 3months for IBD patients
• 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
• Ability to understand the nature of the study and to sign a written informed consent form (ICF)

You may not qualify if:

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

Sponsors & Collaborators

• Galmed Pharmaceuticals Ltd: lead
• Virginia Commonwealth University: collaborator

Study Sites (1)

The Sanyal Institute for Liver Disease &amp; Metabolic Health at VCU

Richmond, Virginia, 23284, United States

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Arun Sanyal, MD

  The Sanyal Institute for Liver Disease & Metabolic Health at VCU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel group analysis

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 23, 2023
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study completion
• Access Criteria: Any person with access to ClinicalTrials.gov

Locations

US (1)