A Study to Evaluate the Effectiveness and Safety of Aramchol Versus Placebo in Subjects With NASH (ARMOR)

Overview

About this study

The purpose of this study is to evaluate the effect of Aramchol as compared to placebo on NASH resolution, fibrosis improvement and clinical outcomes related to progression of liver disease (fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes).

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Male or female, age 18 to 75 years old.
  • 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.
  • Body mass index (BMI) between 25kg/m^2 and 40 kg/m^2.
  • AST> 20 IU/L.
  • Type 2 diabetes mellitus or prediabetes.
  • 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.

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 < 150,000mm^3.
  • 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) co-existing 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Alina Allen, M.D.

Open for enrollment

Contact information:

Suzanne Greiner

(507)293-0913

Greiner.Suzanne2@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available