Status:
SUSPENDED
A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)
Lead Sponsor:
Galmed Research and Development, Ltd.
Conditions:
Nonalcoholic Steatohepatitis (NASH)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
An Open-Label Part was 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 ...
Detailed Description
A total of 150 subjects, including those already randomized to Aramchol 300 mg BID or Placebo, were to be randomized in a ratio of 1:1:1 to receive Aramchol 300 mg BID in the open-label (OL) part acco...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2027
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT04104321
Start Date
September 23 2019
End Date
June 30 2027
Last Update
December 16 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The Public Health Trust of Miami-Dade County, Florida, dba the Jackson Health System
Miami, Florida, United States, 33136
2
Texas Clinical Research Institute, LLC
Arlington, Texas, United States, 76012