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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01094158

Acronym

Aramchol003

Enrollment

Registered

2010-03-26

Start date

2010-11-30

Completion date

2012-01-31

Last updated

2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Non-Alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

Keywords

NAFLD, NASH, Fatty Liver, Metabolic Syndrome, Endothelial Dysfunction, Insulin Resistance, Liver Fat

Brief summary

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.

Detailed description

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.

Interventions

DRUGAramchol

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The difference between initial and final liver triglyceride concentration (measured by NMRS) comparing the Aramchol and placebo treated patients.	3 months

Secondary

Measure	Time frame	Description
Comparing secondary variables of liver, metabolic and endothelial functions between the Aramchol and the placebo arms.	3 months	Comparing liver enzymes, markers of endothelial dysfunction, insulin resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol and the placebo arms

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026