Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01094158
Status:
COMPLETED
Last Update Posted:
2012-01-31
First Post:
2010-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C455117', 'term': 'aramchol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-30', 'studyFirstSubmitDate': '2010-02-17', 'studyFirstSubmitQcDate': '2010-03-25', 'lastUpdatePostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference between initial and final liver triglyceride concentration (measured by NMRS) comparing the Aramchol and placebo treated patients.', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Comparing secondary variables of liver, metabolic and endothelial functions between the Aramchol and the placebo arms.', 'timeFrame': '3 months', 'description': 'Comparing liver enzymes, markers of endothelial dysfunction, insulin resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol and the placebo arms'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NAFLD', 'NASH', 'Fatty Liver', 'Metabolic Syndrome', 'Endothelial Dysfunction', 'Insulin Resistance', 'Liver Fat'], 'conditions': ['Non-Alcoholic Fatty Liver Disease', 'Nonalcoholic Steatohepatitis', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '18989145', 'type': 'BACKGROUND', '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.'}, {'pmid': '12883488', 'type': 'BACKGROUND', 'citation': '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': '24815326', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol versus the placebo arm following three month treatment.\n\nSecondary 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.', 'detailedDescription': '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\n\nThe purpose of the study is to test whether Aramchol will reduce safely and effectively liver fat concentration in patients with NAFLD and NASH.\n\nAramchol 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\n\nPrimary purpose: Compare the changes in liver triglycerides concentration in the Aramchol versus the placebo arm following three month treatment.\n\nSecondary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically proven NAFLD or NASH based on a biopsy performed during the preceding 18 months fulfilling the following criteria:\n\n * At least 15% of hepatocytes showing steatosis,with Fibrosis of not more than stage 3, with at most bridging fibrosis.\n\nPatients 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.\n\n* Triglycerides concentration in the liver of 6% or more as measured by NMRS.\n* At least two elevated serum ALT levels in the previous six months, with latest test within 2 months of trial.\n* Normal or only slightly impaired synthetic liver function (serum albumin \\>3.5gm%, INR 0.8-1.3)\n* Male or female aged 18-75 years.\n* Negative pregnancy test at study entry for females of child bearing potential.\n* Females of child bearing potential practicing reliable contraception throughout the study period.\n* Signature of the written informed consent\n\nExclusion Criteria:\n\n* Evidence of cirrhosis on liver biopsy.\n* Evidence of fibrosis of more than stage 3 on liver biopsy.\n* 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.\n* BMI \\> 35 or \\>130 kg body weight\n* Any other concomitant, significant: metabolic, infectious, inflammatory, neoplastic, or other non-liver disease.\n* Various concomitant diseases requiring chronic steroid administration.\n* Use of warfarin, metformin, thiaglitazones, insulin or current steroid therapy of more than 3 days.\n* Use of other investigational agents \\< 30 days prior to the study.\n* Pregnancy\n* Daily alcohol intake \\> 10gm/day.\n* 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.\n* Performance status: WHO performance status ≥4.'}, 'identificationModule': {'nctId': 'NCT01094158', 'acronym': 'Aramchol003', 'briefTitle': 'Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galmed Medical Reserch'}, 'officialTitle': 'A Phase II Placebo Controlled Randomised Study of Aramchol on Liver Triglyceride in Patients With Steatosis Due to NAFLD or NASH', 'orgStudyIdInfo': {'id': 'Aramchol NAFLD Phase-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high dose', 'description': 'Aramchol 300 mg daily (high dose)', 'interventionNames': ['Drug: Aramchol']}, {'type': 'EXPERIMENTAL', 'label': 'low dose', 'description': '100 mg daily (low dose)', 'interventionNames': ['Drug: Aramchol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo and two doses will be compared. The Aramchol: placebo ratio is of 2:1.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aramchol', 'type': 'DRUG', 'otherNames': ['Arachidyl amido cholanoic acid'], 'description': '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', 'armGroupLabels': ['low dose']}, {'name': 'Aramchol', 'type': 'DRUG', 'otherNames': ['Arachidyl amido cholanoic acid'], 'description': '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', 'armGroupLabels': ['high dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'tablets packaged in bottles given orally once a day in the morning within approximately 10 minutes after breakfast', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '34362', 'city': 'Haifa', 'country': 'Israel', 'facility': 'The Lady Davis Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Ein Kerem M.C', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '44281', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'city': 'Nazareth', 'country': 'Israel', 'facility': 'Holy Family HOSPITAL', 'geoPoint': {'lat': 32.70087, 'lon': 35.29719}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Belinson,Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '76100', 'city': 'Rehovot', 'country': 'Israel', 'facility': 'Kaplan M.C', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '13100', 'city': 'Safed', 'country': 'Israel', 'facility': 'Safed Ziv Hospital', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'The Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Ran Oren, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liver & Gastroenterology Department,The Tel Aviv Sourasky Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galmed Medical Reserch', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, {'name': 'Beilinson Hospital, Petach Tikva,Israel', 'class': 'UNKNOWN'}, {'name': 'Meir Medical Center', 'class': 'OTHER'}, {'name': 'Kaplan Hospital ,Rehovot,Israel', 'class': 'UNKNOWN'}, {'name': 'Soroka Hospital,Beer Sheva,Israel', 'class': 'UNKNOWN'}, {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, {'name': 'Rambam Hospital, Haifa, Israel', 'class': 'UNKNOWN'}, {'name': 'The Lady Davis Carmel Medical Center', 'class': 'UNKNOWN'}, {'name': 'Holy Family Hospital, Nazareth, Israel', 'class': 'OTHER'}, {'name': 'Ziv Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Doctor Ran Oren', 'oldOrganization': 'Liver unit, Department of Gastroenterology and Hepatology, Sourasky Medical Center. Tel Aviv.'}}}}