The Food and Drug Administration (FDA) has granted Fast Track designation for NuSirt Biopharma’s development program involving the triple combination of leucine, metformin and sildenafil for the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).

The program includes a Phase 2 clinical trial, TRIPLN, which initiated enrollment for NASH and NAFLD patients. TRIPLN is a randomized, 16-week, placebo-controlled, double-blind study evaluating the change in liver fat content. Patients will receive two fixed-doses of the triple combination of leucine, metformin and sildenafil. Secondary objectives include assessment of various liver, metabolic, and inflammatory markers. Preliminary results are expected the second quarter of 2016.

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Preclinical studies for this triple combination showed its potential to reverse NAFLD, reduce disease symptoms, and prevent NAFLD and NASH. Researchers previously presented their findings at the American Association for the Study of Liver Diseases (AASLD)’s annual The Liver Meeting in November 2015.

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