Adults 18 to 75, any sex, with Nonalcoholic Steatohepatitis (NASH). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Open Label Part: Improvement of Fibrosis Based on Liver BiopsyPrimary· 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
Fibrosis improvement (relative FCS reduction by ≥25% AI cutoff)
Group
Value
95% CI
Aramchol
41.2
27.6 – 55.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 124 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Patients Randomized to the OL Part of the ARMOR Study
Serious: 1/154 (1%)
Deaths: 154/154
Serious adverse events (19 terms)
Reaction
System
Patients Randomized to the…
coronary artery disease
Cardiac disorders
—
Coronary artery stenosis
Cardiac disorders
—
Retinal detachment
Eye disorders
—
Non-cardiac chest pain
General disorders
—
Cholecystitis acute
Hepatobiliary disorders
—
Cholecystitis chronic
Hepatobiliary disorders
—
COVID-19
Infections and infestations
—
COVID-19 pneumonia
Infections and infestations
—
Pneumonia
Infections and infestations
—
Lumbar vertebral fracture
Injury, poisoning and procedural complications
—
Post-procedural complication
Injury, poisoning and procedural complications
—
Post-procedural haemorrhage
Injury, poisoning and procedural complications
—
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
—
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Other recruiting trials for Nonalcoholic Steatohepatitis (NASH)
Currently open trials in the same condition.
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· recruiting
NCT05842512 — Study of ADI-PEG 20 Versus Placebo in Subjects With NASH
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· recruiting
NCT05692492 — A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NAS
· Phase 2
· active not recruiting
NCT03572465 — Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis
· recruiting
Other Galmed Research and Development, Ltd. trials
Trials by the same sponsor.
NCT04480827 — Open-Label Study to Evaluate the Safety, Tolerability, and PK of Aramchol in Subjects With Hepatic Impairment
· Phase 1
· completed
NCT02279524 — A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH
· Phase 2
· completed
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 Research and Development, Ltd.
Last refreshed: 11 February 2026
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/NCT04104321.