- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04104321
A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR) (ARMOR)
A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With Nonalcoholic Steatohepatitis (NASH) With Open-Label Part to Evaluate the Safety, PK and Treatment Response Kinetics of Aramchol. The ARMOR Study
An Open-Label Part is 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- The Public Health Trust of Miami-Dade County, Florida, dba the Jackson Health System
-
-
Texas
-
Arlington, Texas, United States, 76012
- Texas Clinical Research Institute, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- 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
- 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.
Key Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aramchol
Aramchol 300 mg oral tablet
|
Aramchol 300 mg BID
|
Placebo Comparator: Placebo
Placebo matching oral tablet
|
Placebo BID
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Open label part: Kinetics of histological outcome measures
Time Frame: Up to 72 or 120 weeks
|
The primary endpoints are the kinetics of the following histological outcome measures for treatment duration of 24, 48 and 72 weeks and potentially following a 2nd post-baseline biopsy at weeks 72 or 96 or 120, respectively:
|
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:
Time Frame: 72 weeks
|
|
72 weeks
|
Double Blind Part: To evaluate the effect of Aramchol compared to placebo on composite long-term outcome
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).
|
at End of Study, latest at 5 years from last subject's randomization
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aramchol-018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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