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A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)

NCT04104321 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2026-02-11

Study results available
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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.

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.

Conditions

  • Nonalcoholic Steatohepatitis (NASH)

Interventions

DRUG

Aramchol free acid

Aramchol 300 mg BID

DRUG

Placebo

Placebo BID

Sponsors & Collaborators

  • Galmed Research and Development, Ltd.

    lead INDUSTRY

Principal Investigators

  • Yossi Gilgun-Sherki, PhD, MBA · Executive Drug Development Consultant

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-23
Primary Completion
2022-12-08
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04104321 on ClinicalTrials.gov