NCT06095986

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Galmed Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Primary Sclerosing Cholangitis

Interventions

Type	Name	Description
DRUG	Aramchol meglumine	Aramchol meglumine is derived from a weak acid (Aramchol) and an amino-sugar (meglumine)

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-09-01
• Completion: 2027-12-01
• First posted: 2023-10-23
• Last updated: 2025-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study