Lipocine Inc. announced that results of its Phase 2 study evaluating LPCN 1148 are being presented at The American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting 2023, taking place in Boston MA. The results are featured in a late-breaking oral presentation and e-poster by Dr. Arun Sanyal, MD, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University, advisor to Lipocine. The Phase 2 proof of concept study (NCT # 04874350) is a 52-week ongoing randomized placebo-controlled study in sarcopenic male patients with cirrhosis on the liver transplant waitlist.

After week 24, all patients enter a single arm open-label extension (OLE) stage of the study and receive LPCN 1148. The purposes of the OLE are 1) to evaluate the safety and efficacy of continued exposure with LPCN 1148 in this population, and 2) to increase the number of participants on LPCN 1148 treatment.