A Phase 3/4 Clinical Study to Evaluate the Efficacy and Safety of Aramchol Versus Placebo in Subjects With NASH (ARMOR) (ARMOR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04104321|
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : November 4, 2019
A double-blind placebo controlled randomized Phase 3/4 study in subjects with nonalcoholic steatohepatitis (NASH) and fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes.
The primary objectives 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|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3/4, Multinational, Multicenter, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With Nonalcoholic Steatohepatitis (NASH) The ARMOR Study|
|Actual Study Start Date :||September 23, 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||December 2024|
Aramchol 300 mg oral tablet
Aramchol 300 mg BID
Placebo Comparator: Placebo
Placebo matching oral tablet
- To evaluate the effect of Aramchol compared to placebo on liver histology by assessing the following primary endpoints: [ Time Frame: 52 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.
- 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, Texas|
|Texas Clinical Research Institute, LLC||Recruiting|
|Arlington, Texas, United States, 76012|