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Randomised clinical trial: A leucine-metformin-sildenafil combination (NS-0200) vs placebo in patients with non-alcoholic fatty liver disease

Alimentary Pharmacology and Therapeutics May 03, 2018

Chalasani N, et al. - The purpose of this study was to illustrate the results from a Phase 2, randomised clinical trial of NS-0200 in 91 subjects with non-alcoholic fatty liver disease (NAFLD) (liver fat ≥15% by magnetic resonance imaging-proton-density fat fraction (MRI-PDFF)). Subjects were randomised to placebo, low-dose (1.1 g leucine/0.5 g metformin/0.5 mg sildenafil) or high-dose NS-0200 (1.1 g leucine/0.5 g metformin/1.0 mg sildenafil) BD for 16 weeks. Findings displayed that high dose NS-0200 reduced hepatic fat by 15.7% (relative change from baseline) in the high alanine aminotransferase (ALT) group. On the other hand, low dose NS-0200 and placebo did not notably change hepatic fat.
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