Lipocine completed patient enrollment in a proof-of-concept clinical study of LPCN 1144 for the treatment of nonalcoholic steatohepatitis, according to a press release.
The study will assess liver fat changes in men with hypogonadism and fatty liver who are at risk for developing NASH using magnetic resonance imaging-proton density fat fraction after treatment with LPCN 1144, an oral prodrug of bioidentical testosterone.
“Assessing the impact of LPCN 1144 treatment on liver fat changes in hypogonadal men with confirmed fatty liver would enable us to understand the underappreciated association between hypogonadism and nonalcoholic fatty liver disease,” Mahesh Patel, PhD, chairman, president and CEO of Lipocine, said in the release. Additionally, the outcome from this clinical study will be an important foundation for designing future clinical studies of LPCN 1144 for the treatment for NAFLD/NASH.”
The researchers enrolled 36 patients and expect complete study results in the first quarter of 2019.