Primary Sclerosing CholangitisPhase 2NCT06095986
A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis
A Phase 2 study testing Aramchol meglumine in people with Primary Sclerosing Cholangitis, run by Galmed Pharmaceuticals Ltd at 1 site in United States.
Trial summary
The objectives of this study is to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients with Primary Sclerosing Cholangitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- Aramchol meglumine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sanyal Institute for Liver Disease & Metabolic Health at VCU
Richmond, Virginia, 23284
About this study
Official title: 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
The objectives of this study is to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients with Primary Sclerosing Cholangitis
Read the 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
- Being tested
- Aramchol meglumine
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aramchol meglumineDrug
Aramchol meglumine is derived from a weak acid (Aramchol) and an amino-sugar (meglumine)
| Study group | Role | What they receive |
|---|---|---|
| PSC patients administered with Aramchol meglumine | Active comparator | Adult subjects with clinically diagnosed PSC that are administered with Aramchol meglumine Receives: Drug: Aramchol meglumine |
| PSC patients administered with placebo | Placebo comparator | Adult subjects with clinically diagnosed PSC that are administered with matching placebo Receives: Drug: Aramchol meglumine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in serum alkaline phosphatase (ALP)
The change from Baseline to Week 48 in ALP levels
Measured: 48 weeks
Secondary outcomes (10)
Change from Baseline in hepatobiliary fibrosis using the Nakanuma staging scale
Change from Baseline to Week 48 in liver histology using the Nakanuma stage classification. A score of 0 is classified as stage 1 (no or minimal disease progression), while 1 score 5 or 6 is classified as stage 4 (advanced disease progression).
Measured: 48 weeks
Change from Baseline in Enhanced liver fibrosis (ELF)
Change from Baseline to Week 48 in Enhanced liver fibrosis (ELF) test. Score below 7.7 indicate no to mild fibrosis, and score higher than 11.3 indicate cirrhosis.
Measured: 48 weeks
Change from Baseline in MRCP
Change from Baseline to Week 48 in magnetic resonance cholangiopancreatography (MRCP)
Measured: 48 weeks
Change from Baseline in quantitative liver function using Gadoxetate clearance
Change from Baseline to Week 48 in quantitative liver function using Gadoxetate clearance
Measured: 48 weeks
Change from Baseline in 5D-itch scale
Change from Baseline to Week 48 in the 5 dimension itch scale (5d-itch scale) measuring pruritus (the 5 dimensions are degree, duration, direction, disability and distribution). Higher degree mean worse outcome <8 on rating scale mean no pruritus, and >22 on rating scale indicate severe pruritus
Measured: 48 weeks
Change from Baseline to Week 48 in Patient-Reported Outcomes Measurement Information System (PROMIS)-19 score
Change from Baseline to Week 48 in the Patient-Reported Outcomes Measurement Information System (PROMIS)-19 questionnaire score. The average score for Physical Function is 50, with a score of 40 considered below average and a score of 60 considered above average
Measured: 48 weeks
Change from Baseline in the Mayo IBD symptom severity score
Change from Baseline to Week 48 in the Mayo Inflammatory bowel disease (IBD) symptom severity score. A score of 3 to 5 points indicates mildly active disease and a score of 11 to 12 points indicates severely active bowel disease
Measured: 48 weeks
Change from Baseline in the revised Mayo risk score (rMRS)
Change from Baseline to Week 48 in the revised Mayo risk score (rMRS). The score provide the estimated probability of survival (%) based on age, bilirubin, AST, and history of bleeding
Measured: 48 weeks
Change from Baseline in the UK-PSC score
Change from Baseline to Week 48 in the united kingdom primary sclerosing cholangitis (UK-PSC) score. The score provide the estimated probability of survival (%) based on age, bilirubin, albumin, platelets, hemoglobin and ALP
Measured: 48 weeks
Change from Baseline in the PSC risk estimate tool (PREsTo)
Change from Baseline to Week 48 in the PSC risk estimate tool (PREsTo). The tool consists of bilirubin, albumin, ALP, platelets, AST, hemoglobin, sodium, patient age and the number of years since PSC was diagnosed, and it predicts short-term and long-term need for liver transplantation or death.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study startJun 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Operational and clinical reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group analysis
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galmed Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Virginia Commonwealth University
- Responsible party
- Sponsor
- Investigators
- Arun Sanyal, MD, Principal investigator, The Sanyal Institute for Liver Disease & Metabolic Health at VCU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095986
- Sponsor's protocol ID
- AM-002
- Status last verified
- Jun 2025
- First submitted
- 11 Oct 2023
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share the study protocol and SAP
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06095986
- Acronym / sponsor ID
- AM-002
- Conditions
- Primary Sclerosing Cholangitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Operational and clinical reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Galmed Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Collaborators
- Virginia Commonwealth University
- Study start
- Jun 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group analysis
| Arm | Type | Receives |
|---|---|---|
| PSC patients administered with Aramchol meglumine | Active comparator | Drug: Aramchol meglumineAdult subjects with clinically diagnosed PSC that are administered with Aramchol meglumine |
| PSC patients administered with placebo | Placebo comparator | Drug: Aramchol meglumineAdult subjects with clinically diagnosed PSC that are administered with matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aramchol meglumineAramchol meglumine is derived from a weak acid (Aramchol) and an amino-sugar (meglumine) | Drug | PSC patients administered with Aramchol meglumine, PSC patients administered with placebo |
Primary outcome
Change from Baseline in serum alkaline phosphatase (ALP)
Time frame: 48 weeks
The change from Baseline to Week 48 in ALP levels
10 secondary outcomes
Change from Baseline in hepatobiliary fibrosis using the Nakanuma staging scale
Time frame: 48 weeks
Change from Baseline in Enhanced liver fibrosis (ELF)
Time frame: 48 weeks
Change from Baseline in MRCP
Time frame: 48 weeks
Change from Baseline in quantitative liver function using Gadoxetate clearance
Time frame: 48 weeks
Change from Baseline in 5D-itch scale
Time frame: 48 weeks
Change from Baseline to Week 48 in Patient-Reported Outcomes Measurement Information System (PROMIS)-19 score
Time frame: 48 weeks
Change from Baseline in the Mayo IBD symptom severity score
Time frame: 48 weeks
Change from Baseline in the revised Mayo risk score (rMRS)
Time frame: 48 weeks
Change from Baseline in the UK-PSC score
Time frame: 48 weeks
Change from Baseline in the PSC risk estimate tool (PREsTo)
Time frame: 48 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: Yes. Share the study protocol and SAP
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Sanyal, MD principal investigator
The Sanyal Institute for Liver Disease & Metabolic Health at VCU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aramchol meglumine in people with Primary Sclerosing Cholangitis, run by Galmed Pharmaceuticals Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in serum alkaline phosphatase (ALP) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.