Nonalcoholic Steatohepatitis (NASH)Phase 3ARMORNCT04104321
A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)
A Phase 3 study testing Aramchol free acid in people with Nonalcoholic Steatohepatitis (NASH), run by Galmed Research and Development, Ltd. at 2 sites in United States.
Trial summary
An Open-Label Part was added: This part will enroll in selected sites which are less affected by the COVID-19 pandemic. 150 subjects with NASH and fibrosis confirmed by liver histology (F1-F3) will be randomized into 3 groups according to the post-baseline biopsy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis (NASH)
- What is being tested?
- Aramchol free acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Sep 2019to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 18 to 75 years
- Histological confirmation of NASH on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to randomization or during the screening period)
- Total NAS Score 4 or more with at least 1 in each component of the NAS Score (steatosis ≥1 AND inflammation ≥1 AND ballooning ≥1)
- Fibrosis Stage must be 2 or 3 (Open-Label Part may include up to 30 subjects with fibrosis stage 1)
- Body mass index (BMI) between 25kg/m2 and 40 kg/m2 (Open Label part: BMI <40 kg/m2)
- AST>20 IU/L
Show all 10Show fewer
- Type 2 diabetes mellitus or prediabetes (Open Label Part only: Type 2 diabetes or prediabetes is not an inclusion criteria)
- For subjects with type 2 diabetes, glycemia must be controlled
- Females of childbearing potential must practice a highly effective method of contraception throughout the study period and for 1 month after treatment discontinuation.
- Able to understand the nature of the study and to provide signature of the written informed consent.
Who cannot join
- Histologically documented liver cirrhosis (fibrosis stage 4)
- Inability or unwillingness to undergo a liver biopsy
- Abnormal synthetic liver function
- ALT or AST >5× upper limit of normal (ULN)
- Platelet count < 150,000mm3
- Alkaline phosphatase ≥2× ULN
Show all 19Show fewer
- Known or suspected hepatocellular carcinoma (HCC)
- Model for End-Stage Liver Disease (MELD) score > 12
- Prior history or presence of decompensated liver disease
- Other (acute or chronic) coexisting liver disease based on medical history and/or centralized review of liver histology)
- Known alcohol and/or any other drug abuse or dependence in the last five years
- Weight loss of more than 5% within 3 months prior to screening
- History of bariatric surgery within 5 years of liver biopsy or planned surgery for weight reduction
- Treatment with drugs that may cause NAFLD within 12 months prior to liver biopsy
- Treatment with some anti-diabetic medications; Unless started prior to biopsy (timeframe depending on drug) and stable
- Current or planned treatment with immunosuppressive drugs
- Evidence of any other unstable or untreated clinically significant disease
- Uncontrolled hypertension
- Any other condition that in the opinion of the Investigator warrants exclusion from the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012
The Public Health Trust of Miami-Dade County, Florida, dba the Jackson Health System
Miami, Florida, 33136
About this study
Official title: A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy PK, Kinetics and Safety of Aramchol in Nonalcoholic Steatohepatitis (NASH) With Open-Label Part
An Open-Label Part was added:
This part will enroll in selected sites which are less affected by the COVID-19 pandemic.
Read more
150 subjects with NASH and fibrosis confirmed by liver histology (F1-F3) will be randomized into 3 groups according to the post-baseline biopsy.
The objective of the Open-Label Part is:
- To evaluate the safety and PK of twice daily administration (BID) of Aramchol 300mg in subjects with NASH and liver fibrosis.
- To explore the kinetics of histological outcome measures and Non-Invasive Tests (NITs) associated with NASH and fibrosis for the treatment duration of 24, 48 and 72 weeks.
All patients will be allocated to Aramchol.
Double Blind Part:
This part is double blind, placebo controlled randomized in subjects with NASH and fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes.
The primary objectives of this part of the study are to evaluate the effect of Aramchol as compared to placebo on NASH resolution, fibrosis improvement and clinical outcomes related to progression of liver disease.
Subjects will be randomized to receive Aramchol 300mg BID or matching placebo in a 2:1 randomization ratio.
This double-blind phase of the study will recruit patients once the study will be continued.
Read the detailed description
A total of 150 subjects, including those already randomized to Aramchol 300 mg BID or Placebo, were to be randomized in a ratio of 1:1:1 to receive Aramchol 300 mg BID in the open-label (OL) part according to the grouping below:
Group A: The post-baseline liver biopsy was to be conducted at Week 24 Group B: The post-baseline liver biopsy was to be conducted at Week 48 Group C: The post-baseline liver biopsy was to be conducted at Week 72
In order to more comprehensively explore the kinetics of histological outcome measures (e.g., are there subjects who did not show improvement in outcome at Weeks 24, 48, or 72, but improved with longer duration of treatment), a second post-baseline liver biopsy sample was to be collected for subjects whose post-baseline liver biopsy at Weeks 24 or 48, or 72 did not show at least one stage improvement in fibrosis (fibrosis non-responders). The second post-baseline liver biopsy sample was to be collected one year later (i.e., at Weeks 72 or 96 or 120, respectively).
Subjects already randomized and ongoing in the PC part were given the option to switch to the OL part
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Being tested
- Aramchol free acid, Placebo
- Keywords
- fibrosis, liver fibrosis, diabetes, obesity
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fibrosis, Liver Cirrhosis, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aramchol free acidDrug
Also called Two tablets of Aramchol free acid
Aramchol 300 mg BID
PlaceboDrug
Also called Two tablet of Aramchol matching placebo
Placebo BID
| Study group | Role | What they receive |
|---|---|---|
| Aramchol free acid | Experimental | Aramchol 300 mg oral tablet Receives: Drug: Aramchol free acid |
| Placebo | Placebo comparator | Placebo matching oral tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Open Label Part: Improvement of Fibrosis Based on Liver Biopsy
Improvement of fibrosis was defined by the following:
- One stage or more reduction in fibrosis stage as assesed by the NASH-CRN classification
- Ranked paired assessment between post-baseline compared to baseline biopsies (i,proved, worsened or stable fibrosis)
- Reduction in the the continous phenotypic Fibrosis composite severity (Ph-FCS) score ≥0.3 in absolute value or ≥25% in relative value
Measured: Up to 72 or 120 weeks
Double Blind Part: To Evaluate the Effect of Aramchol Compared to Placebo on Liver Histology by Assessing the Following Primary Endpoints. Study Was Suspended and Thus Results Are Expected 2027
- Resolution of NASH defined as the Proportion (%) of subjects with resolution of NASH (defined by Ballooning of 0 and inflammation 0-1) and no worsening of liver fibrosis, or
- Improvement in Fibrosis defined as the Proportion (%) of subjects with improvement in liver fibrosis greater than or equal to one stage and no worsening of steatohepatitis.
Measured: 72 weeks
Double Blind Part: To Evaluate the Effect of Aramchol Compared to Placebo on Composite Long-term Outcome Study Was Suspended so Results Expected 2027
Proportion (%) of subjects experiencing at least 1 of the following events: All-cause mortality, Liver transplant, Histological progression to cirrhosis, MELD score >15, Hospitalization due to hepatic decompensation event(s).
Measured: at End of Study, latest at 5 years from last subject's randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start23 Sep 2019
- Primary completion8 Dec 2022
- Study completion30 Jun 2027 (estimated)
Why it stopped: Interim analysis results from the open-label part of the study. The double blind portion of the study will be resumed once the study will continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Steatohepatitis (NASH)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- In the Open Label part of the study, there will be a single group of 150 subjects (expected) all receiving Aramchol 300mg BID.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galmed Research and Development, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yossi Gilgun-Sherki, PhD, MBA, Study director, Executive Drug Development Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104321
- Sponsor's protocol ID
- Aramchol-018
- Acronym
- ARMOR
- Status last verified
- Jan 2026
- First submitted
- 18 Sep 2019
- Last updated
- 11 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ratziu V, Yilmaz Y, Lazas D, Friedman SL, Lackner C, Behling C, Cummings OW, Chen L, Petitjean M, Gilgun-Sherki Y, Gorfine T, Kadosh S, Eyal E, Sanyal AJ. Aramchol improves hepatic fibrosis in metabolic dysfunction-associated steatohepatitis: Results of multimodality assessment using both conventional and digital pathology. Hepatology. 2025 Mar 1;81(3):932-946. doi: 10.1097/HEP.0000000000000980. Epub 2024 Jun 25.
PubMed 38916482
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy PK, Kinetics and Safety of Aramchol in Nonalcoholic Steatohepatitis (NASH) With Open-Label Part
- ClinicalTrials.gov ID
- NCT04104321
- Acronym / sponsor ID
- ARMOR / Aramchol-018
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Keywords
- fibrosis, liver fibrosis, diabetes, obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Interim analysis results from the open-label part of the study. The double blind portion of the study will be resumed once the study will continue.
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Galmed Research and Development, Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Sep 2019 (actual)
- Results
- Posted 16 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Open-Label Part was added:
This part will enroll in selected sites which are less affected by the COVID-19 pandemic.
150 subjects with NASH and fibrosis confirmed by liver histology (F1-F3) will be randomized into 3 groups according to the post-baseline biopsy.
The objective of the Open-Label Part is:
- To evaluate the safety and PK of twice daily administration (BID) of Aramchol 300mg in subjects with NASH and liver fibrosis.
- To explore the kinetics of histological outcome measures and Non-Invasive Tests (NITs) associated with NASH and fibrosis for the treatment duration of 24, 48 and 72 weeks.
All patients will be allocated to Aramchol.
Double Blind Part:
This part is double blind, placebo controlled randomized in subjects with NASH and fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes.
The primary objectives of this part of the study are to evaluate the effect of Aramchol as compared to placebo on NASH resolution, fibrosis improvement and clinical outcomes related to progression of liver disease.
Subjects will be randomized to receive Aramchol 300mg BID or matching placebo in a 2:1 randomization ratio.
This double-blind phase of the study will recruit patients once the study will be continued.
Detailed description
A total of 150 subjects, including those already randomized to Aramchol 300 mg BID or Placebo, were to be randomized in a ratio of 1:1:1 to receive Aramchol 300 mg BID in the open-label (OL) part according to the grouping below:
Group A: The post-baseline liver biopsy was to be conducted at Week 24 Group B: The post-baseline liver biopsy was to be conducted at Week 48 Group C: The post-baseline liver biopsy was to be conducted at Week 72
In order to more comprehensively explore the kinetics of histological outcome measures (e.g., are there subjects who did not show improvement in outcome at Weeks 24, 48, or 72, but improved with longer duration of treatment), a second post-baseline liver biopsy sample was to be collected for subjects whose post-baseline liver biopsy at Weeks 24 or 48, or 72 did not show at least one stage improvement in fibrosis (fibrosis non-responders). The second post-baseline liver biopsy sample was to be collected one year later (i.e., at Weeks 72 or 96 or 120, respectively).
Subjects already randomized and ongoing in the PC part were given the option to switch to the OL part
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In the Open Label part of the study, there will be a single group of 150 subjects (expected) all receiving Aramchol 300mg BID.
| Arm | Type | Receives |
|---|---|---|
| Aramchol free acid | Experimental | Drug: Aramchol free acidAramchol 300 mg oral tablet |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching oral tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female age 18 to 75 years
- Histological confirmation of NASH on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to randomization or during the screening period)
- Total NAS Score 4 or more with at least 1 in each component of the NAS Score (steatosis ≥1 AND inflammation ≥1 AND ballooning ≥1)
- Fibrosis Stage must be 2 or 3 (Open-Label Part may include up to 30 subjects with fibrosis stage 1)
- Body mass index (BMI) between 25kg/m2 and 40 kg/m2 (Open Label part: BMI <40 kg/m2)
Key exclusion criteria (19 listed)
- Histologically documented liver cirrhosis (fibrosis stage 4)
- Inability or unwillingness to undergo a liver biopsy
- Abnormal synthetic liver function
- ALT or AST >5× upper limit of normal (ULN)
- Platelet count < 150,000mm3
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 free acidAlso: Two tablets of Aramchol free acidAramchol 300 mg BID | Drug | Aramchol free acid |
| PlaceboAlso: Two tablet of Aramchol matching placeboPlacebo BID | Drug | Placebo |
Primary outcome
Open Label Part: Improvement of Fibrosis Based on Liver Biopsy
Time frame: Up to 72 or 120 weeks
Improvement of fibrosis was defined by the following: 1. One stage or more reduction in fibrosis stage as assesed by the NASH-CRN classification 2. Ranked paired assessment between post-baseline compared to baseline biopsies (i,proved, worsened or stable fibrosis) 3. Reduction in the the continous phenotypic Fibrosis composite severity (Ph-FCS) score ≥0.3 in absolute value or ≥25% in relative value
Double Blind Part: To Evaluate the Effect of Aramchol Compared to Placebo on Liver Histology by Assessing the Following Primary Endpoints. Study Was Suspended and Thus Results Are Expected 2027
Time frame: 72 weeks
* Resolution of NASH defined as the Proportion (%) of subjects with resolution of NASH (defined by Ballooning of 0 and inflammation 0-1) and no worsening of liver fibrosis, or * Improvement in Fibrosis defined as the Proportion (%) of subjects with improvement in liver fibrosis greater than or equal to one stage and no worsening of steatohepatitis.
Double Blind Part: To Evaluate the Effect of Aramchol Compared to Placebo on Composite Long-term Outcome Study Was Suspended so Results Expected 2027
Time frame: at End of Study, latest at 5 years from last subject's randomization
Proportion (%) of subjects experiencing at least 1 of the following events: All-cause mortality, Liver transplant, Histological progression to cirrhosis, MELD score >15, Hospitalization due to hepatic decompensation event(s).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38916482Ratziu V, Yilmaz Y, Lazas D, Friedman SL, Lackner C, Behling C, Cummings OW, Chen L, Petitjean M, Gilgun-Sherki Y, Gorfine T, Kadosh S, Eyal E, Sanyal AJ. Aramchol improves hepatic fibrosis in metabolic dysfunction-associated steatohepatitis: Results of multimodality assessment using both conventional and digital pathology. Hepatology. 2025 Mar 1;81(3):932-946. doi: 10.1097/HEP.0000000000000980. Epub 2024 Jun 25.
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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.
Yossi Gilgun-Sherki, PhD, MBA study director
Executive Drug Development Consultant
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aramchol free acid in people with Nonalcoholic Steatohepatitis (NASH), run by Galmed Research and Development, Ltd. at 2 sites 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 10 inclusion and 19 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: paused, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Open Label Part: Improvement of Fibrosis Based on Liver Biopsy (time frame: Up to 72 or 120 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04104321, which also lists 1 linked publication.
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 11 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.