An investigational testosterone prodrug resulted in improvements in skeletal muscle mass and quality, and lowered rates of hepatic encephalopathy in men with cirrhosis and sarcopenia, according to a small phase II pilot study. In a modified intention-to-treat analysis, men with cirrhosis had an increase in the L3-skeletal muscle index (L3-SMI) of 4.1 cm /m after 24 weeks of treatment with LPCN 1148, compared with a drop of 0.
6 cm /m in the L3-SMI among those who received a placebo ( <0.01), reported Arun Sanyal, MD, of the Virginia Commonwealth University in Richmond, at the in Milan. The result represented a placebo-adjusted 9.
9% increase in the L3-SMI in the LPCN 1148 group, and the increase was maintained through week 48, Sanyal told attendees. Also, when the six participants in the placebo group switched to treatment with LPCN 1148 at week 24, their L3-SMI increased significantly by 8.1 cm /m , or 16.
7%, at week 48 ( <0.01). "Sarcopenia is common in cirrhosis and impacts clinically meaningful outcomes," he noted.
"In addition, it increases healthcare resource utilization." "There are multiple mechanisms that contribute to sarcopenia in cirrhosis," Sanyal pointed out. "Of these, several pathways are impacted by androgens, which are linked to muscle mass inhibit myostatin.
Of men with cirrhosis, 90% have low-free testosterone." LPCN 1148 is an oral ester prodrug of bioidentical testosterone, . "It's not an exogenous testosterone analog," Sanyal emphasized.
Based on its andr.