Title

Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis
A Phase II Placebo Controlled Randomised Study of Aramchol on Liver Triglyceride in Patients With Steatosis Due to NAFLD or NASH
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    aramchol ...
  • Study Participants

    60
Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol versus the placebo arm following three month treatment.

Secondary purpose: Comparing liver enzymes, markers of endothelial dysfunction, insulin resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol and the placebo arms.
A Phase II, multicenter, double blind, randomized, placebo controlled study on the effect of Aramchol on liver triglycerides concentration in patients with steatosis due to NAFLD or NASH

The purpose of the study is to test whether Aramchol will reduce safely and effectively liver fat concentration in patients with NAFLD and NASH.

Aramchol inhibits the liver enzyme Stearoyl Coenzyme A Desaturase (SCD). It reduces fatty acid synthesis while increasing fatty acid oxidation. It was shown to reduce liver fat in animal models with diet induced Fatty Liver. It has also marked hypocholesterolemic effects, mainly via upregulation of theABCA1 cholesterol transporter. It thus causes(incomplete) SCD inhibition while being antiatherogenic

Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol versus the placebo arm following three month treatment.

Secondary purpose: Comparing liver enzymes, markers of endothelial dysfunction, insulin resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol and the placebo arms.
Study Started
Nov 30
2010
Primary Completion
Nov 30
2011
Study Completion
Jan 31
2012
Last Update
Jan 31
2012
Estimate

Drug Aramchol

100mg/d tablets packaged in bottles given orally once a day in the morning within 10 minutes after breakfast for a total period time of 3 months

  • Other names: Arachidyl amido cholanoic acid

Drug Aramchol

300 mg/d tablets packaged in bottles given orally once a day in the morning within 10 minutes after breakfast for a total period time of 3 months

  • Other names: Arachidyl amido cholanoic acid

Drug Placebo

tablets packaged in bottles given orally once a day in the morning within approximately 10 minutes after breakfast

high dose Experimental

Aramchol 300 mg daily (high dose)

low dose Experimental

100 mg daily (low dose)

Placebo Placebo Comparator

Placebo and two doses will be compared. The Aramchol: placebo ratio is of 2:1.

Criteria

Inclusion Criteria:

Patients with histologically proven NAFLD or NASH based on a biopsy performed during the preceding 18 months fulfilling the following criteria:

At least 15% of hepatocytes showing steatosis,with Fibrosis of not more than stage 3, with at most bridging fibrosis.

Patients with a NAFLD activity score 0-2 will be considered to have NAFLD. Biopsies with an activity score of 3 or more will be considered NASH.

Triglycerides concentration in the liver of 6% or more as measured by NMRS.
At least two elevated serum ALT levels in the previous six months, with latest test within 2 months of trial.
Normal or only slightly impaired synthetic liver function (serum albumin >3.5gm%, INR 0.8-1.3)
Male or female aged 18-75 years.
Negative pregnancy test at study entry for females of child bearing potential.
Females of child bearing potential practicing reliable contraception throughout the study period.
Signature of the written informed consent

Exclusion Criteria:

Evidence of cirrhosis on liver biopsy.
Evidence of fibrosis of more than stage 3 on liver biopsy.
Patient with liver disease due to acute or chronic hepatitis A, B,C, HIV, and all other liver diseases affecting liver function. Patients with cysts, hemangiomas, or similar abnormalities, are accepted.
BMI > 35 or >130 kg body weight
Any other concomitant, significant: metabolic, infectious, inflammatory, neoplastic, or other non-liver disease.
Various concomitant diseases requiring chronic steroid administration.
Use of warfarin, metformin, thiaglitazones, insulin or current steroid therapy of more than 3 days.
Use of other investigational agents < 30 days prior to the study.
Pregnancy
Daily alcohol intake > 10gm/day.
Patients with symptoms of significant mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent.
Performance status: WHO performance status ≥4.
No Results Posted