Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-02-25 @ 4:14 AM
Study NCT ID:
NCT02532335
Status:
UNKNOWN
Last Update Posted:
2020-08-25
First Post:
2015-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obeticholic Acid in Morbidly Obese Patients and Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C464660', 'term': 'obeticholic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-22', 'studyFirstSubmitDate': '2015-08-21', 'studyFirstSubmitQcDate': '2015-08-24', 'lastUpdatePostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ChIP-assay in biopsies as a measure of Activation of FXR-dependent genes in small intestine', 'timeFrame': 'Three weeks', 'description': 'ChIP-assay in biopsies'}], 'secondaryOutcomes': [{'measure': 'Shot-gun metagenomics as a measure of Impact of FXR activation on gut microbiota', 'timeFrame': 'Three weeks', 'description': 'Shot-gun metagenomics'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FXR', 'bile acids', 'FGF19', 'C4', 'gut microbiota', 'Pharmacodynamics of FXR activation in the small bowel'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'OCAPUSH (EudraCT 2014-002313-33) is a double-blind placebo-controlled parallel-arms study of the effects of obeticholic acid on farnesoid X receptor expression in jejunum and on gut microbiota in morbidly obese patients and healthy volunteers. Obeticholic acid (OCA, 6-ethyl-chenodeoxycholic acid, INT-747) is a semi-synthetic derivative of the major human bile acid chenodeoxycholic acid and will be administered orally at a dose of 25 mg/day during three weeks to 20 morbidly obese patients awaiting Roux-en-Y gastric bypass and to 20 healthy volunteers. On the days before the first and after the last dose faeces and blood are sampled for the analyses of bile acids and the gut microbiota. On the day after the last dose a push-enteroscopy is performed in conscious sedation for biopsy taking in the jejunum.These procedures are repeated 6 month after surgery in the morbid obese patients. Inclusion criteria are male or female gender, 20-65 years of age and morbid obesity (BMI \\>35 kg/m2) eligible for bariatric surgery. Exclusion criteria are liver diseases other that fatty liver disease, other significant morbidity, medications known to interact with OCA, pregnancy, uncertainty about safe and reliable contraception, and problems to understand or adhere to the protocol. The primary objectives of this pharmacodynamic trial are the study of the effect of OCA on the expression of FXR in the jejunum and small intestinal permeability, and on fecal bile acids and gut microbiota. The secondary objectives are the study of the effects of OCA on the genome-wide FXR DNA binding sites (cistromics) with the global gene expression profile (transcriptomics) in human jejunum.', 'detailedDescription': 'Obeticholic acid will be administered orally at a dose of 25 mg/day during three weeks to 20 morbidly obese patients awaiting Roux-en-Y gastric bypass and to 20 healthy volunteers. On the days before the first and after the last dose faeces and blood are sampled for the analyses of bile acids and the gut microbiota. On the day after the last dose a push-enteroscopy is performed in conscious sedation for biopsy taking in the jejunum. These procedures are repeated 6 month after surgery in the morbid obese patients. Inclusion criteria are male or female gender, 20-65 years of age and morbid obesity (BMI \\>35 kg/m2) eligible for bariatric surgery. Exclusion criteria are liver diseases other that fatty liver disease, other significant morbidity, medications known to interact with OCA, pregnancy, uncertainty about safe and reliable contraception, and problems to understand or adhere to the protocol. The primary objectives of this pharmacodynamic trial are the study of the effect of OCA on the expression of FXR in the jejenum and small intestinal permeability, and on fecal bile acids and gut microbiota. The secondary objectives are the study of the effects of OCA on the genome-wide FXR DNA binding sites (cistromics) with the global gene expression profile (transcriptomics) in human jejunum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMorbid obesity awaiting gastric bypass surgery, ≥35 kg/m2\n\nMale subjects, pre-, and post-menopausal female subjects\n\nWomen of childbearing potential can only be included if a safe and reliable contraception is used, e.g., oral contraceptives\n\nPatients eligible to laparoscopic bariatric surgery\n\nPatients must give their signed and dated written consent to participate in this study based on written information of all pertinent aspects of the trial provided at least 24 hours before undertaking any trial related activity.\n\nExclusion Criteria:\n\nChronic liver disease other than NAFLD (viral hepatitis, autoimmune liver disease, hemochromatosis, homozygous alpha1-antitrypsin deficiency and Wilson disease)\n\nPrevious gastric or small bowel surgery\n\nInflammatory bowel disease\n\nUncontrolled diabetes mellitus (fasting blood glucose \\>6.7 mmol/L), hypothyroidism or hyperthyroidism, or other significant endocrine disease.\n\nPregnancy. A urine pregnancy test will be performed the day before start of medication. Women of childbearing potential can only be included if a safe and reliable contraception is used, e.g., oral contraceptives.\n\nElevations of transaminases (ALAT/ASAT) or alkaline phosphatase or bilirubin above 2xULN (upper limit of normal) the day before start of medication.\n\nOther serious disease, including depressive disorders treated by medication\n\nPatients who will not comply with the protocol.\n\nHypothyroidism, unless the subject is clinically euthyroid, receiving a stable dose thyroid hormone replacement therapy and serum TSH is within the normal range.'}, 'identificationModule': {'nctId': 'NCT02532335', 'acronym': 'OCAPUSH', 'briefTitle': 'Obeticholic Acid in Morbidly Obese Patients and Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Study of the Effects of Obeticholic Acid on Farnesoid X Receptor Expression in Jejunum and on Gut Microbiota in Morbidly Obese Patients and Healthy Volunteers', 'orgStudyIdInfo': {'id': 'OCAPUSH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Morbid Obesity OCA', 'description': 'Obeticholic acid 25 mg/day in three weeks', 'interventionNames': ['Drug: Obeticholic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Morbid Obesity Placebo', 'description': 'Obeticholic acid 25 mg/day matching placebo in three weeks', 'interventionNames': ['Drug: Obeticholic acid', 'Drug: Obeticholic acid placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Volunteers OCA', 'description': 'Obeticholic acid Obeticholic acid 25 mg/day in three weeks', 'interventionNames': ['Drug: Obeticholic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Healthy volunteers Placebo', 'description': 'Obeticholic acid 25 mg/day matching placebo in three weeks', 'interventionNames': ['Drug: Obeticholic acid', 'Drug: Obeticholic acid placebo']}], 'interventions': [{'name': 'Obeticholic acid', 'type': 'DRUG', 'otherNames': ['INT-747'], 'description': 'active drug', 'armGroupLabels': ['Healthy Volunteers OCA', 'Healthy volunteers Placebo', 'Morbid Obesity OCA', 'Morbid Obesity Placebo']}, {'name': 'Obeticholic acid placebo', 'type': 'DRUG', 'otherNames': ['INT-747 placebo'], 'description': 'matching placebo', 'armGroupLabels': ['Healthy volunteers Placebo', 'Morbid Obesity Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '411 31', 'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Hanns-Ulrich Marschall', 'role': 'CONTACT', 'email': 'hanns-ulrich.marschall@gu.se', 'phone': '+4670774073'}, {'name': 'Hanns-Ulrich Marschall, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hanns-Ulrich Marschall', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Gothenburg', 'status': 'ENROLLING_BY_INVITATION', 'country': 'Sweden', 'facility': 'Sahlgrenska Academy', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Hanns-Ulrich Marschall, MD, PhD, MSc', 'role': 'CONTACT', 'email': 'hanns-ulrich.marschall@gu.se', 'phone': '+46708774073'}], 'overallOfficials': [{'name': 'Hanns-Ulrich Marschall', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical Hepatology, Sponsor', 'investigatorFullName': 'Hanns-Ulrich Marschall', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}