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This study evaluates a drug called Obeticholic acid, compared with placebo, in people with obesity or gallstone disease. It enrolled people with a body mass index of 35 or higher and people with symptomatic, ultrasound-confirmed gallstones. The study was carried out in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * In the obesity group: BMI ≥35 kg/m2 * In the gallstone group: symptomatic, ultrasound verified gallstone disease Exclusion Criteria: * Chronic liver disease other than NAFLD (viral hepatitis, autoimmune liver disease, hemochromatosis, homozygous alpha1-antitrypsin deficiency and Wilson disease) * Previous gastric or small bowel surgery * Inflammatory bowel disease * Uncontrolled diabetes mellitus (fasting blood glucose \>6.7 mmol/L), hypothyroidism or hyperthyroidism, or other significant endocrine disease. * Pregnancy. 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. * Elevations of transaminases (ALAT/ASAT) or alkaline phosphatase or bilirubin above 2xULN (upper limit of normal) the day before start of medication. * Other serious disease, including depressive disorders treated by medication * Patients who will not comply with the protocol. * A subject who is euthyroid on a stable replacement dose of thyroid hormone is acceptable provided the TSH is within normal range.