A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR) (ARMOR)
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|ClinicalTrials.gov Identifier: NCT04104321|
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : February 17, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Nonalcoholic Steatohepatitis (NASH)||Drug: Aramchol Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
In the Double-Blind part of the study, subjects will be randomized in a ratio of 2:1 to receive Aramchol 300mg BID or matching placebo, respectively.
In the Open Label part of the study, there will be a single group of 150 subjects (expected) all receiving Aramchol 300mg BID.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||September 23, 2019|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||June 2027|
Aramchol 300 mg oral tablet
Aramchol 300 mg BID
Placebo Comparator: Placebo
Placebo matching oral tablet
- 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:
- Improvement in Fibrosis defined as the Proportion (%) of subjects with improvement in liver fibrosis greater than or equal to one stage (NASH CRN fibrosis score) and no worsening of steatohepatitis (defined as no increase in NAS for ballooning, inflammation or steatosis)
- Resolution of NASH defined as the Proportion (%) of subjects with resolution of NASH (defined by ballooning of 0 and inflammation 0-1) and no worsening of liver fibrosis on NASH CRN fibrosis score (≥ 1 stage increase).
- 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 ]
- Resolution of NASH defined as the Proportion (%) of subjects with resolution of NASH (defined by Ballooning of 0 and inflammation 0-1) and no worsening of liver fibrosis, or
- Improvement in Fibrosis defined as the Proportion (%) of subjects with improvement in liver fibrosis greater than or equal to one stage and no worsening of steatohepatitis.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04104321
|United States, Florida|
|The Public Health Trust of Miami-Dade County, Florida, dba the Jackson Health System||Recruiting|
|Miami, Florida, United States, 33136|
|United States, Texas|
|Texas Clinical Research Institute, LLC||Recruiting|
|Arlington, Texas, United States, 76012|