Obeticholic Acid in Bariatric and Gallstone Disease
OCABSGS
Effects of Obeticholic Acid on Hepatic Fatty Acid/Triglyceride Metabolism and Hepatobiliary Detoxification/Elimination in Morbidly Obese and Gallstone Patients
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 obesity
Started Sep 2013
Typical duration for phase_2 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2012
CompletedFirst Posted
Study publicly available on registry
June 21, 2012
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedOctober 18, 2016
October 1, 2016
2.6 years
June 19, 2012
October 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effects of OCA on FXR-dependent metabolism
Primary endpoints * 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
Day 21
Secondary Outcomes (1)
Effects of OCA on serum lipid levels
21 days
Study Arms (4)
Morbid Obesity OCA
ACTIVE COMPARATORObeticholic acid 25 mg/day in three weeks
Morbid Obesity Placebo
PLACEBO COMPARATORObeticholic acid 25 mg/day matching placebo in three weeks
Gallstones OCA
ACTIVE COMPARATORObeticholic acid 25 mg/day in three weeks
Gallstones Placebo
PLACEBO COMPARATORObeticholic acid 25 mg/day matching placebo in three weeks
Interventions
Obeticholic acid 25 mg/day in three weeks
Placebo to obeticholic acid
Eligibility Criteria
You may qualify if:
- In the obesity group: BMI ≥35 kg/m2
- In the gallstone group: symptomatic, ultrasound verified gallstone disease
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sahlgrenska University Hospitallead
- Medical University of Viennacollaborator
Study Sites (1)
Hanns-Ulrich Marschall
Gothenburg, 411 31, Sweden
Related Publications (1)
Al-Dury S, Wahlstrom A, Panzitt K, Thorell A, Stahlman M, Trauner M, Fickert P, Backhed F, Fandriks L, Wagner M, Marschall HU. Obeticholic acid may increase the risk of gallstone formation in susceptible patients. J Hepatol. 2019 Nov;71(5):986-991. doi: 10.1016/j.jhep.2019.06.011. Epub 2019 Jun 27.
PMID: 31254596DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hanns-Ulrich Marschall, MD, PhD
Sahlgrenska University Hospital Gothenburg
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Clinical Hepatology
Study Record Dates
First Submitted
June 19, 2012
First Posted
June 21, 2012
Study Start
September 1, 2013
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
October 18, 2016
Record last verified: 2016-10