Clinical Edge

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Obeticholic acid reversed NASH liver fibrosis in phase 3 trial

Key clinical point: Obeticholic acid is the first drug to have a beneficial impact on nonalcoholic steatohepatitis patients in a phase 3 trial.

Major finding: Liver fibrosis regressed in 23% of patients on 25 mg obeticholic acid daily and in 12% of control patients.

Study details: REGENERATE, an international, phase 3 trial with 931 patients.

Disclosures: REGENERATE was sponsored by Intercept, the company that markets obeticholic acid (Ocaliva). Dr. Younossi is a consultant to and has received research funding from Intercept. He has also been a consultant to Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Novartis, Novo Nordisk, Quest, Siemens, Terns Pharmaceutical, and Viking Therapeutics. Dr. Newsome has been a consultant or speaker for Intercept as well as Boehringer Ingelheim, Dignity Sciences, Johnson & Johnson, Novo Nordisk, and Shire, and he has received research funding from Pharmaxis and Boehringer Ingelheim.