Journal
CONTEMPORARY CLINICAL TRIALS
Volume 84, Issue -, Pages -Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2019.06.017
Keywords
Farnesoid X receptor; Nonalcoholic fatty liver disease; Nonalcoholic steatohepatitis; NASH; Obeticholic acid
Funding
- Intercept Pharmaceuticals, Inc., United States
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Background: Nonalcoholic steatohepatitis (NASH) is a chronic, progressive, and severe form of nonalcoholic fatty liver disease. In FLINT, obeticholic acid (OCA) treatment improved multiple histological NASH features. The design and endpoints of REGENERATE, an ongoing phase 3 study, further evaluate OCA treatment in patients with fibrosis due to NASH. Aims: The Month 18 interim analysis assesses the effect of OCA on liver histology, defined as improvement of fibrosis by >= 1 stage with no worsening of NASH or resolution of NASH with no worsening of fibrosis. The end of -study analyses evaluate the effect of OCA on mortality, liver-related clinical outcomes, and long-term safety. Methods: REGENERATE is a pivotal, long-term study of similar to 2400 patients with NASH, including similar to 2100 patients with stage 2 or 3 liver fibrosis. Additionally, similar to 300 patients with stage 1 fibrosis and a >= 1 accompanying comorbidity are included to gather information on the safety of OCA and liver disease progression. Patients are randomised 1:1:1 to receive placebo or OCA (10 or 25 mg). A liver biopsy evaluation occurs at screening, Months 18 and 48, and end of study. The duration of the study is dependent upon accrual of a predetermined number of clinical outcome events. Conclusions: REGENERATE is designed in conjunction with regulatory authorities to support regulatory approvals in NASH. This robust phase 3 study assesses the effect of OCA on liver histology as a surrogate for transplant-free survival and liver-related outcomes, including progression to cirrhosis and mortality, and will ultimately assess clinical benefit through specific evaluation of these outcomes.
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