Fatty liver disease, morbid obesity, gallstone disease MedDRA version: 14.1 Level: LLT Classification code 10029530 Term: Non-alcoholic fatty liver System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Product Name: Obeticholic acid
Product Code: INT-747
Pharmaceutical Form: Tablet
Sponsors
Sahlgrenska Academy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 20 to 65 years; in the obesity group: BMI =35 kg/m2 in the gallstone group: symptomatic, ultrasound verified gallstone disease Sex Males, pre-, and post-menopausal females Diagnosis Patients eligible to laparoscopic bariatric and gallstone surgery, respectively Consent Patients should have given their written consent to participate in this study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 (a subject who is euthyroid on a stable replacement dose of thyroid hormone is acceptable provided the TSH is within normal range). Other serious disease, including depressive disorders treated by medication Patients who will not comply with the protocol. Pregnancy. Women in childbearing age must adhere to secure anticonception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main trial objectives are to determine whether (i)INT-747 (25 mg/day) improves insulin resistance in patients with non-alcoholic fatty liver disease (NAFLD) (iii)INT-747 alters hepatic and/or white adipose tissue (WAT) lipase activity and fatty acid/triglyceride (FA/TG) content in NAFLD (iv)INT-747 improves hepatobiliary transporter expression in NAFLD and gallstone disease (v)INT-747 improves biliary lipid profiles towards lower cholesterol saturation ;Secondary Objective: Secondary trial objectives are to determine whether (i) INT-747 changes in serum cholesterol and triglycerides (ii) INT-747 changes in energy consumption;Primary end point(s): - relative changes in markers for insulin resistance - relative changes in FA and TG - relative changes in hepatic and adipose tissue lipase expression and activity - relative changes in hepatic apical transport proteins ABCG5/8, BSEP, MDR3, MRP2 - relative changes in hepatic ER stress markers | — |
Countries
Sweden
Outcome results
None listed