Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis (Aramchol003)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01094158
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : January 31, 2012
Sponsor:
Collaborators:
Tel-Aviv Sourasky Medical Center
Beilinson Hospital, Petach Tikva,Israel
Meir Medical Center
Kaplan Hospital ,Rehovot,Israel
Soroka Hospital,Beer Sheva,Israel
Hadassah Medical Organization
Hillel Yaffe Medical Center
Rambam Hospital, Haifa, Israel
The Lady Davis Carmel Medical Center
Holy Family Hospital, Nazareth, Israel
Ziv Hospital
Information provided by:
Galmed Medical Reserch

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.


Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Metabolic Syndrome Drug: Aramchol Drug: Placebo Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Placebo Controlled Randomised Study of Aramchol on Liver Triglyceride in Patients With Steatosis Due to NAFLD or NASH
Study Start Date : November 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
Experimental: high dose
Aramchol 300 mg daily (high dose)
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 Name: Arachidyl amido cholanoic acid

Experimental: low dose
100 mg daily (low dose)
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 Name: Arachidyl amido cholanoic acid

Placebo Comparator: Placebo
Placebo and two doses will be compared. The Aramchol: placebo ratio is of 2:1.
Drug: Placebo
tablets packaged in bottles given orally once a day in the morning within approximately 10 minutes after breakfast




Primary Outcome Measures :
  1. The difference between initial and final liver triglyceride concentration (measured by NMRS) comparing the Aramchol and placebo treated patients. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Comparing secondary variables of liver, metabolic and endothelial functions between the Aramchol and the placebo arms. [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT01094158


Locations
Layout table for location information
Israel
Soroka Medical Center
Beer Sheva, Israel, 84101
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Rambam
Haifa, Israel, 31096
The Lady Davis Carmel Medical Center
Haifa, Israel, 34362
Hadassah Ein Kerem M.C
Jerusalem, Israel, 91120
Meir Medical Center
Kfar Saba, Israel, 44281
Holy Family HOSPITAL
Nazareth, Israel
Belinson,Rabin Medical Center
Petah Tikva, Israel, 49100
Kaplan M.C
Rehovot, Israel, 76100
Safed Ziv Hospital
Safed, Israel, 13100
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Galmed Medical Reserch
Tel-Aviv Sourasky Medical Center
Beilinson Hospital, Petach Tikva,Israel
Meir Medical Center
Kaplan Hospital ,Rehovot,Israel
Soroka Hospital,Beer Sheva,Israel
Hadassah Medical Organization
Hillel Yaffe Medical Center
Rambam Hospital, Haifa, Israel
The Lady Davis Carmel Medical Center
Holy Family Hospital, Nazareth, Israel
Ziv Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ran Oren, Doctor Liver & Gastroenterology Department,The Tel Aviv Sourasky Medical Center

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Doctor Ran Oren, Liver unit, Department of Gastroenterology and Hepatology, Sourasky Medical Center. Tel Aviv.
ClinicalTrials.gov Identifier: NCT01094158     History of Changes
Other Study ID Numbers: Aramchol NAFLD Phase-II
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Galmed Medical Reserch:
NAFLD
NASH
Fatty Liver
Metabolic Syndrome
Endothelial Dysfunction
Insulin Resistance
Liver Fat

Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Cholic Acids
Gastrointestinal Agents