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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01094158
Other study ID # Aramchol NAFLD Phase-II
Secondary ID
Status Completed
Phase Phase 2
First received February 17, 2010
Last updated January 30, 2012
Start date November 2010
Est. completion date January 2012

Study information

Verified date January 2012
Source Galmed Medical Reserch
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 2012
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel Soroka Medical Center Beer Sheva
Israel Hillel Yaffe Medical Center Hadera
Israel Rambam Haifa
Israel The Lady Davis Carmel Medical Center Haifa
Israel Hadassah Ein Kerem M.C Jerusalem
Israel Meir Medical Center Kfar Saba
Israel Holy Family HOSPITAL Nazareth
Israel Belinson,Rabin Medical Center Petah Tikva
Israel Kaplan M.C Rehovot
Israel Safed Ziv Hospital Safed
Israel The Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (12)

Lead Sponsor Collaborator
Galmed Medical Reserch Beilinson Hospital, Petach Tikva,Israel, Hadassah Medical Organization, Hillel Yaffe Medical Center, Holy Family Hospital, Nazareth, Israel, Kaplan Hospital ,Rehovot,Israel, Meir Medical Center, Rambam Hospital, Haifa, Israel, Soroka Hospital,Beer Sheva,Israel, Tel-Aviv Sourasky Medical Center, The Lady Davis Carmel Medical Center, Ziv Hospital

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Gilat T, Leikin-Frenkel A, Goldiner I, Juhel C, Lafont H, Gobbi D, Konikoff FM. Prevention of diet-induced fatty liver in experimental animals by the oral administration of a fatty acid bile acid conjugate (FABAC). Hepatology. 2003 Aug;38(2):436-42. — View Citation

Leikin-Frenkel A, Goldiner I, Leikin-Gobbi D, Rosenberg R, Bonen H, Litvak A, Bernheim J, Konikoff FM, Gilat T. Treatment of preestablished diet-induced fatty liver by oral fatty acid-bile acid conjugates in rodents. Eur J Gastroenterol Hepatol. 2008 Dec;20(12):1205-13. doi: 10.1097/MEG.0b013e3282fc9743. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The difference between initial and final liver triglyceride concentration (measured by NMRS) comparing the Aramchol and placebo treated patients. 3 months Yes
Secondary Comparing secondary variables of liver, metabolic and endothelial functions between the Aramchol and the placebo arms. Comparing liver enzymes, markers of endothelial dysfunction, insulin resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol and the placebo arms 3 months Yes
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