Shares of Lipocine (NASDAQ: LPCN) traded slightly higher on Monday after the company reported that it had completed enrollment into its Phase 2 study to evaluate the therapeutic potential of LPCN 1148.

The company said that the Phase 2 proof-of-concept study is planned to be a randomized, placebo-controlled clinical trial conducted in male sarcopenic cirrhotic patients across two stages.

During the first stage, subjects will be randomly assigned to either a treatment group that receives an oral dose of LPCN 1148 or a placebo group. The primary endpoint of the study is the change in skeletal muscle index at week 24.

Other important secondary endpoints will include measuring changes in the liver frailty index and myosteatosis, rates of breakthrough HE (a type of hepatic encephalopathy), and the number of waitlist events, including all-cause mortality.

The total duration of treatment in the study, including both the placebo-controlled first stage and the single-active arm open-label extension of the second stage, is planned for 52 weeks.

The company said that it expects to have initial 24-week topline data by mid-2023.

LPCN 1148 is a new prodrug that is designed to be taken orally and activates the androgen receptor to improve liver and muscle function.

It is intended to improve the quality of life of individuals with liver cirrhosis while they are waiting for a liver transplant, reduce the number of hospital admissions, and prevent or reduce the occurrence and recurrence of decompensation events. The drug is believed to have a multifaceted mechanism of action that is expected to be beneficial in these ways.

Decompensated liver cirrhosis is a serious condition that is estimated to affect more than 500,000 Americans, with men being affected at twice the rate of women. It is a leading cause of death with approximately 45,000 deaths occurring each year. The only current cure for the condition is a liver transplant.

Lipocine also reported that it intends to exploration collaboration opportunities for LPCN 1148.

Shares of Lipocine trade on the NASDAQ under the ticker symbol LPCN. For more information visit www.lipocine.com.