NCT01094158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

February 17, 2010

Last Update Submit

January 30, 2012

Conditions

Non-Alcoholic Fatty Liver DiseaseNonalcoholic SteatohepatitisMetabolic Syndrome

Keywords

NAFLDNASHFatty LiverMetabolic SyndromeEndothelial DysfunctionInsulin ResistanceLiver Fat

Outcome Measures

Primary Outcomes (1)

  • The difference between initial and final liver triglyceride concentration (measured by NMRS) comparing the Aramchol and placebo treated patients.

    3 months

Secondary Outcomes (1)

  • Comparing secondary variables of liver, metabolic and endothelial functions between the Aramchol and the placebo arms.

    3 months

Study Arms (3)

high dose

EXPERIMENTAL

Aramchol 300 mg daily (high dose)

Drug: Aramchol

low dose

EXPERIMENTAL

100 mg daily (low dose)

Drug: Aramchol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AramcholDRUG

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

Also known as: Arachidyl amido cholanoic acid
low dose
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Soroka Medical Center

Beersheba, 84101, Israel

Location

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Rambam

Haifa, 31096, Israel

Location

The Lady Davis Carmel Medical Center

Haifa, 34362, Israel

Location

Hadassah Ein Kerem M.C

Jerusalem, 91120, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Holy Family HOSPITAL

Nazareth, Israel

Location

Belinson,Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Kaplan M.C

Rehovot, 76100, Israel

Location

Safed Ziv Hospital

Safed, 13100, Israel

Location

The Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (3)

  • 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.

    PMID: 18989145BACKGROUND

  • 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. doi: 10.1053/jhep.2003.50348.

    PMID: 12883488BACKGROUND

  • Safadi R, Konikoff FM, Mahamid M, Zelber-Sagi S, Halpern M, Gilat T, Oren R; FLORA Group. The fatty acid-bile acid conjugate Aramchol reduces liver fat content in patients with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2014 Dec;12(12):2085-91.e1. doi: 10.1016/j.cgh.2014.04.038. Epub 2014 May 9.

    PMID: 24815326DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseMetabolic SyndromeFatty LiverInsulin Resistance

Interventions

aramchol

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ran Oren, Doctor

    Liver & Gastroenterology Department,The Tel Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 17, 2010

First Posted

March 26, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

IL(11)