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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at end of study, latest at 5 years from last subject's randomization
Awards & highlights
Pivotal 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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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%
Nasopharyngitis
6%
Abdominal distension
6%
Diarrhea
6%
Abdominal pain upper
6%
Bronchitis
5%
Influenza
5%
Back Pain
5%
Asthenia
5%
Dyspepsia
5%
Cough
4%
Upper Respiratory Tract Infection
4%
Abdominal pain
4%
Arthralgia
3%
Fatigue
3%
Vomiting
1%
Abdominal wall haematoma
1%
Lumbar radiculopathy .
1%
Depression
1%
Confusional state
1%
Chest pain
1%
Femur fracture
1%
Lymphoma
1%
Intervertebral disc protrusion
1%
Humerus fracture
1%
Radicular syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aramchol 600mg
Placebo
Aramchol 400mg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
328 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
247 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~0 spots leftby Dec 2024
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