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Norursodeoxycholic acid vs placebo in the treatment of non-alcoholic fatty liver disease: A double-blind, randomised, placebo-controlled, phase 2 dose-finding trial

The Lancet: Gastroenterology & Hepatology Jul 27, 2019

Traussnigg S, et al. - Researchers conducted this multicentre, double-blind, placebo-controlled, randomised, phase 2 dose-finding clinical trial in tertiary referral hospitals and medical centres in Austria (n=6) and Germany (n=23) to evaluate the effectiveness of two doses of norursodeoxycholic acid vs placebo for the treatment of non-alcoholic fatty liver disease. The study sample consisted of patients with non-alcoholic fatty liver disease with or without diabetes. When compared with placebo, norursodeoxycholic acid at 1500 mg led in a significant reduction in serum alanine aminotransferase within 12 weeks of therapy. Norursodeoxycholic acid was safe and well-tolerated promoting additional studies. Headache, gastrointestinal disorders, diarrhoea, abdominal pain, nasopharyngitis were the most frequent adverse events.
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