LPCN - Lipocine announces completion of enrollment in the LPCN 1144 lift study

Lipocine (LPCN) -1.2% announced that the last patient has been enrolled in its LiFT Phase 2 clinical study.LPCN 1144, an oral prodrug of endogenous testosterone has shown meaningful reductions of liver fat in our proof of concept liver fat imaging study in hypogonadal males and has demonstrated treatment potential in a pre-clinical NASH and hepatic fibrosis rabbit model.Moreover, no notable tolerability issues have been seen in 700+ hypogonadal subjects with up to 52-week exposure. There is a growing body of preclinical and clinical evidence supporting the relationship between testosterone deficiency and NAFLD/NASH. The majority of biopsy-confirmed NASH male patients reportedly have low testosterone and the levels of free T decrease significantly with increased fibrosis. Lipocine expects to report top-line change in liver fat data measured by MRI-PDFF (primary endpoint), in January 2021.Subsequently, 36-week biopsy and MRI-PDFF data are expected mid-2021.  For more information, refer to NCT04134091.

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Lipocine announces completion of enrollment in the LPCN 1144 lift study