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Non-Alcoholic Fatty Liver DiseasePhase 2Aramchol003NCT01094158

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

A Phase 2 study testing Aramchol in people with Non-Alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by Galmed Medical Reserch at 11 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Aramchol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
11 sitesIsrael
Study dates
Nov 2010to Jan 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Israel11 sites

  • Soroka Medical Center

    Beersheba, 84101

  • Hillel Yaffe Medical Center

    Hadera, 38100

  • Rambam

    Haifa, 31096

  • The Lady Davis Carmel Medical Center

    Haifa, 34362

  • Hadassah Ein Kerem M.C

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 44281

  • Holy Family HOSPITAL

    Nazareth

  • Belinson,Rabin Medical Center

    Petah Tikva, 49100

  • Kaplan M.C

    Rehovot, 76100

  • Safed Ziv Hospital

    Safed, 13100

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

About this study

Official title: A Phase II Placebo Controlled Randomised Study of Aramchol on Liver Triglyceride in Patients With Steatosis Due to NAFLD or NASH

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.

Read the 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.

Being tested
Aramchol, Placebo
Keywords
NAFLD, NASH, Fatty Liver, Metabolic Syndrome, Endothelial Dysfunction, Insulin Resistance, Liver Fat
Medical subject headings
Non-alcoholic Fatty Liver Disease, Metabolic Syndrome, Fatty Liver, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AramcholDrug

    Also called Arachidyl amido cholanoic acid

    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

  • AramcholDrug

    Also called Arachidyl amido cholanoic acid

    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

  • PlaceboDrug

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

Study groups in NCT01094158
Study groupRoleWhat they receive
high doseExperimentalAramchol 300 mg daily (high dose)
Receives: Drug: Aramchol
low doseExperimental100 mg daily (low dose)
Receives: Drug: Aramchol
PlaceboPlacebo comparatorPlacebo and two doses will be compared. The Aramchol: placebo ratio is of 2:1.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months

Secondary outcomes (1)

  1. 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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionNov 2011
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01094158
Sponsor's protocol ID
Aramchol NAFLD Phase-II
Acronym
Aramchol003
Status last verified
Jan 2012
First submitted
17 Feb 2010
Last updated
31 Jan 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18989145

  • 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.

    PubMed 12883488

  • 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.

    PubMed 24815326

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aramchol in people with Non-Alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by Galmed Medical Reserch at 11 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference between initial and final liver triglyceride concentration (measured by NMRS) comparing the Aramchol and placebo treated patients. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01094158, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2012; AzTrials last refreshed its copy on 8 Nov 2026.

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