The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment (FLINT) Trial
Treatment of obeticholic acid on fatty liver disease as measured by changes in NAFLD activity score and enzyme levels
PI: Rohit Loomba
The FLINT trial is a multi-center, randomized, double-masked, placebo-controlled, phase 2b clinical trial of treatment with either obeticholic acid or placebo in patients with NASH. The trial aims to determine if administration of the farnesoid X receptor (FXR) ligand obeticholic acid (OCA) for 72 weeks to subjects with biopsy evidence of nonalcoholic steatohepatitis (NASH) will result in improvement in their liver disease as measured by changes in the NAFLD activity score (NAS). The study drug being tested in the FLINT Trial, obeticholic acid, is a modified bile acid that changes the body’s metabolism of lipids and might be beneficial for NASH. Bile acids are made by your liver to help digest food and then recycled by your body to be used again.
This treatment trial study consists of follow up visits every three months upon start of study medication. We plan to recruit a total of 35 patients for the UC San Diego site. Patients will be recruited from NAFLD/NASH clinics and by referrals from other physicians.
For each subject, the screening visit take approximately 2 hours, with each follow-up visits ranging from 1-1.5 hours. Patients will get a baseline MRI scan to determine liver fat content level as well as a baseline oral glucose tolerance test. These baseline values will be analyzed against end-of study values to see the effects of the bile acid on the body’s lipid metabolism and insulin resistance. Study participants will be asked to come in a fasting state for the blood draw and will receive a physical exam and undergo imaging (magnetic resonance techniques and ultrasound). In addition, participants will be asked questions about alcohol consumption and medication use.
Currently UC San Diego is one of the top NASH CRN recruiting sites for FLINT patient recruitment
Note: We are currently enrolling patients for this study.
Informed Consent Forms:
For more information please see ClinicalTrials.gov
For additional questions regarding this study please contact:
Clinical Research Coordinator
200 West Arbor drive, MC 8413
San Diego, CA 92103-8413
Phone: (619) 543-5459
Fax: (619) 543-2160