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LPCN 1144 Resolves NAFLD in Hypogonadal Males.
Somaya Albhaisi1, Kilyoung Kim2, Jonathan Baker2
1Department of Internal Medicine Virginia Commonwealth University School of Medicine Richmond VA.
Hepatology Communications
|October 7, 2020
Summary
Hypogonadism is linked to fatty liver disease (NAFLD). Treatment with LPCN 1144, an oral testosterone prodrug, improved liver fat in 81% of hypogonadal males, resolving NAFLD in 48% after 16 weeks.
Area of Science:
- Endocrinology
- Hepatology
- Metabolic Disorders
Background:
- Hypogonadism is associated with impaired hepatic lipid metabolism, potentially contributing to nonalcoholic fatty liver disease (NAFLD).
- Understanding NAFLD prevalence in hypogonadal males is crucial for targeted therapeutic strategies.
Purpose of the Study:
- To determine the prevalence of NAFLD in males with hypogonadism.
- To evaluate the efficacy of LPCN 1144, an oral testosterone prodrug, in improving liver fat content and resolving NAFLD in this population.
Main Methods:
- A multicenter, open-label, single-arm trial involving hypogonadal males treated with LPCN 1144.
- Serial magnetic resonance imaging-proton density fat fraction measurements were used to assess liver fat content in a subset of 36 participants.
Main Results:
- NAFLD prevalence was 66% in the study population, defined by liver fat fraction ≥5%.
- LPCN 1144 therapy led to significant reductions in liver fat, with NAFLD resolution in 48% of subjects after 16 weeks (mean relative reduction: 55%).
- Liver fat reduction was more pronounced in individuals with higher baseline liver fat content. Normalization of liver enzymes was also observed.
Conclusions:
- LPCN 1144 effectively resolves NAFLD in a significant proportion of hypogonadal males.
- The oral testosterone prodrug demonstrated a favorable safety profile without major adverse events.
- Further research is warranted to explore the potential of LPCN 1144 in treating nonalcoholic steatohepatitis in this demographic.
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