Obeticholic Acid in Bariatric and Gallstone Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-04-30

Brief Summary

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By binding to the nuclear receptor FXR, bile acids not only regulate their own turn-over but presumably also pivotal steps in cholesterol, triglyceride and glucose metabolism as shown in laboratory animals. Obeticholic acid (OCA) is a semisynthetic bile acid with very high affinity to FXR. In a pharmacodynamic study the effects of OCA on bile acid, lipid and glucose turn-over are studied in 20 morbidly obese and 20 gallstones patents, respectively, that are administered OCA at 25 mg/day in three weeks before bariatric (BS) or gallstone (GS) surgery where in addition to blood samples also biopsies are taken from the liver and in the case of BS, omental and subcutaneous adipose tissue and in case of GS, gallbladder bile.

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Detailed Description

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In a placebo-controlled double-blind randomized trial, 20 otherwise healthy morbidly obese patients scheduled for bariatric surgery, and 20 otherwise healthy gallstone patients will be administered 25 mg/day INT-747 or placebo for three weeks until the day before surgery. Serum from days 1 and 21 will be analyzed for routine liver tests, bile acids, a complete lipid profile including FA and in addition for 7α-hydroxy-4-cholesten-3-one and FGF-19, markers for bile acid synthesis and its intestinal stimulation. For the evaluation of insulin resistance and possible pre-diabetes, plasma will be taken for the estimation of HOMA index and oral glucose tolerance test (OGTT) will be performed at days 1 and 21. At surgery, a liver biopsy (0.5-1 g) and a white adipose tissue (WAT) specimen (1 cm2) will be taken and immediately frozen in liquid nitrogen for mRNA and protein preparation for quantitative RT-PCR and Western analysis, respectively, histopathological NAFLD grading, and measuring of hepatic and WAT lipase activity. In gallstone patients, gallbladder bile will be sampled for the measurements of biliary lipids (cholesterol, phospholipids, bile acids) and the calculation of the cholesterol saturation index.

Conditions

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Obesity Gallstones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Morbid Obesity OCA

Obeticholic acid 25 mg/day in three weeks

Group Type ACTIVE_COMPARATOR

Obeticholic acid

Intervention Type DRUG

Obeticholic acid 25 mg/day in three weeks

Morbid Obesity Placebo

Obeticholic acid 25 mg/day matching placebo in three weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to obeticholic acid

Gallstones OCA

Obeticholic acid 25 mg/day in three weeks

Group Type ACTIVE_COMPARATOR

Obeticholic acid

Intervention Type DRUG

Obeticholic acid 25 mg/day in three weeks

Gallstones Placebo

Obeticholic acid 25 mg/day matching placebo in three weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to obeticholic acid

Interventions

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Obeticholic acid

Obeticholic acid 25 mg/day in three weeks

Intervention Type DRUG

Placebo

Placebo to obeticholic acid

Intervention Type DRUG

Other Intervention Names

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INT-747 Placebo INT-747

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No