Trials & Filings

Intercept Halts NASH Trial

Interim analysis shows primary endpoint met

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Intercept Pharmaceuticals has halted the FLINT trial of obeticholic acid (OCA) for the treatment of nonalcoholic steatohepatitis (NASH) for efficacy, based on a planned interim analysis showing that the primary endpoint of the trial has been met. FLINT is a multi-center, double-blind, placebo-controlled clinical trial assessing the safety and efficacy of a 25 mg oral dose of OCA administered daily to biopsy-proven adult NASH patients during a 72-week treatment period. The decision to stop the t...

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