Who is sponsoring NCT06095986?

NCT06095986 is sponsored by Galmed Pharmaceuticals Ltd.

What drugs are being tested in NCT06095986?

Interventions in NCT06095986: Aramchol meglumine.

What condition does NCT06095986 study?

NCT06095986 studies Primary Sclerosing Cholangitis.

Is NCT06095986 still recruiting?

NCT06095986 is currently withdrawn. Last updated 10 June 2025.

Last reviewed 2025-06-10 · How we verify

NCT06095986

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Withdrawn Phase 2 Last updated 10 June 2025

What this trial tests

Phase 2 trial testing Aramchol meglumine in Primary Sclerosing Cholangitis. Withdrawn.

Timeline

1 June 2025

Primary endpoint
1 September 2026

1 December 2027

Quick facts

Lead sponsor	Galmed Pharmaceuticals Ltd
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Start date	1 June 2025
Primary completion	1 September 2026
Estimated completion	1 December 2027
Sites	1 location across United States

Drugs / interventions tested

Aramchol meglumine — full drug profile →

Conditions studied

Primary Sclerosing Cholangitis — all drugs for Primary Sclerosing Cholangitis →

Sponsor

Galmed Pharmaceuticals Ltd — full company profile →

Who can join

18 and older, any sex, with Primary Sclerosing Cholangitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change from Baseline in serum alkaline phosphatase (ALP)
Time frame: 48 weeks
The change from Baseline to Week 48 in ALP levels

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Bile Acids-Based Therapies for Primary Sclerosing Cholangitis: Current Landscape and Future Developments.
Fiorucci S, Urbani G, Di Giorgio C, Biagioli M, et al · · 2024 · cited 9× · PMID 39404413 · DOI 10.3390/cells13191650
Biliary fibrosis is an important but neglected pathological feature in hepatobiliary disorders: from molecular mechanisms to clinical implications.
Zhao J, Yue P, Mi N, Li M, et al · · 2024 · cited 5× · PMID 39135601 · DOI 10.1515/mr-2024-0029
Fatty Acid Metabolism in Health and Cancer: From Fundamental Mechanisms to Therapeutic Application.
Hang N, Zhao R, Zhang F, Guo D, et al · · 2026 · PMID 42164655 · DOI 10.1002/mco2.70749

Verify or expand the search:

Other recruiting trials for Primary Sclerosing Cholangitis

Currently open trials in the same condition.

NCT07229911 — A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC) · Phase 1 · recruiting
NCT06905054 — Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation · Phase 2 · recruiting
NCT06455280 — A Study of SIPLIZUMAB in AILD and LT Patients · Phase 1 · recruiting
NCT06519162 — Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome · recruiting
NCT06351696 — The Effects of Bromelain Supplement in Patients With Ulcerative Colitis · NA · recruiting

Other Galmed Pharmaceuticals Ltd trials

Trials by the same sponsor.

NCT07251712 — Single and Multiple Dose Pharmacokinetics (PK) of Aramchol From an Aramchol Meglumine Tablet · Phase 1 · recruiting
NCT05857215 — A First-in-Human Study of Single and Multiple Doses of Amilo-5MER in Healthy Subjects · Phase 1 · completed
NCT05874336 — An Open-Label, Two-Part Study Designed to Assess the Absolute Bioavailability and Mass Balance of Aramchol · Phase 1 · completed
NCT03774173 — Comparison of Aramchol Concentrations With Once or Twice Daily Dosing · Phase 1 · completed
NCT03760848 — Study of Potential for Drug Interactions Mediated by CYP3A4 Inhibition With Aramchol in Healthy Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06095986 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Galmed Pharmaceuticals Ltd
Last refreshed: 10 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06095986.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing