Lipocine Inc. announced that the first patient has been dosed in its Phase 2 proof-of-concept clinical study (NCT04874350) for the management of liver cirrhosis. The Phase 2 study is a multi-center, randomized, placebo-controlled 52-week study in sarcopenic cirrhotic patients that are on the liver transplant list. The primary endpoint is change from baseline in Skeletal Muscle Index ("SMI") via computed tomography in LPCN 1148 treated subjects compared to placebo at week 24, and key secondary endpoints include measures of frailty (liver frailty index), change in waitlist events, myosteatosis, rate of hospital admissions, all-cause mortality, and decompensation events (including all cause and liver related mortalities and clinically significant worsening) and rates of breakthrough hepatic encephalopathy. Primary endpoint topline results are expected in the second half of 2022.  Decompensated liver cirrhosis is estimated to affect more than 630,000 Americans, with men affected at twice the rate as women, and results in approximately 45,000 deaths every year. The only cure, liver transplant, has a high economic burden (~$812,500/transplant).  The hypothalamus-pituitary-gonadal axis is profoundly altered in advanced cirrhotic patients, leading to endocrine dysfunction. Testosterone levels fall progressively with increased chronic liver disease severity. Low testosterone levels, reported in the majority of male cirrhotic patients, is known to be associated with increased rates of adverse outcomes including varices in the gastrointestinal tract with internal bleeding, ascites, major infections, hepatic decompensation, and worsening of quality of life while awaiting transplant About Compromised Muscle in Cirrhosis: The presence of sarcopenia (loss of muscle mass/area) in 40-70% of cirrhotic men and frailty (a state of decreased physiological reserve/functionality) are associated with increased risk of hospitalization and hepatic decompensation events, a two-fold increase in waitlist mortality, and poor post-transplant outcomes. Moreover, myosteatosis (an excess of fat in muscle tissue) is recognized to negatively correlate with muscle mass, strength, and mobility, an increased MELD score, worse median survival, and higher rates of mortality in cirrhotic patients. About Hepatic Encephalopathy ("HE"): HE is a metabolically induced, potentially reversible, functional disturbance of the brain condition leading to "brain fog" due to the liver's (primary organ) and muscle's (secondary organ) inability to eliminate myo/neuro toxic ammonia from the systemic circulation and is a significant decompensation event associated with cirrhosis. HE is the most potent risk factor for hospitalization, accidental trauma, and mortality. Clinically overt HE is significantly more prevalent in cirrhotic patients with muscle depletion or decreased muscle strength. Reports suggest low testosterone and fat-free mass depletion are predictors of HE in cirrhotic liver transplant candidates. About LPCN 1148: LPCN 1148 is a novel prodrug of testosterone, testosterone laurate ("TL"), for oral administration with compelling potential unique mode of action to improve liver and muscle function, resulting in improved Quality of Life (QOL) while awaiting transplant, decreased hospital admissions, and prevention of progression of decompensation events.