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Aramchol for Non-alcoholic Fatty Liver Disease (ARMOR Trial)

Phase 3
Waitlist Available
Research Sponsored by Galmed Research and Development, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at end of study, latest at 5 years from last subject's randomization
Awards & highlights

ARMOR Trial Summary

This trial is testing a new drug, Aramchol, on patients with NASH (non-alcoholic steatohepatitis) and fibrosis. The study will have two parts: an open-label part, where all patients will receive the drug, and a double-blind part, where some patients will receive a placebo. The primary objectives of the study are to evaluate the safety and efficacy of Aramchol on NASH resolution, fibrosis improvement, and clinical outcomes related to liver disease progression.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

ARMOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ARMOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at end of study, latest at 5 years from last subject's randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and at end of study, latest at 5 years from last subject's randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Double Blind Part: To evaluate the effect of Aramchol compared to placebo on composite long-term outcome
Double Blind Part: To evaluate the effect of Aramchol compared to placebo on liver histology by assessing the following primary endpoints
Open label part: Kinetics of histological outcome measures

Side effects data

From 2018 Phase 2 trial • 247 Patients • NCT02279524
15%
Headache
13%
Urinary tract infection
10%
Pruritus
9%
Nausea
8%
Constipation
6%
Abdominal pain upper
6%
Abdominal distension
6%
Bronchitis
6%
Diarrhea
6%
Nasopharyngitis
5%
Asthenia
5%
Back Pain
5%
Cough
5%
Dyspepsia
5%
Influenza
4%
Abdominal pain
4%
Arthralgia
4%
Upper Respiratory Tract Infection
3%
Vomiting
3%
Fatigue
1%
Abdominal wall haematoma
1%
Femur fracture
1%
Lymphoma
1%
Confusional state
1%
Radicular syndrome
1%
Lumbar radiculopathy .
1%
Chest pain
1%
Humerus fracture
1%
Intervertebral disc protrusion
1%
Depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aramchol 600mg
Aramchol 400mg
Placebo

ARMOR Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AramcholExperimental Treatment1 Intervention
Aramchol 300 mg oral tablet
Group II: PlaceboPlacebo Group1 Intervention
Placebo matching oral tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aramchol
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Galmed Research and Development, Ltd.Lead Sponsor
3 Previous Clinical Trials
327 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
247 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Utah
How old are they?
18 - 65
What site did they apply to?
Texas Clinical Research Institute, LLC
What portion of applicants met pre-screening criteria?
Met criteria
~258 spots leftby Dec 2024