A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia

Summary

This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of LPCN 1148 in men with cirrhosis of the liver and sarcopenia.

Timeline

Start

2021-11-30

Primary completion

2023-12-18

Completion

2023-12-18

Outcome

Met primary endpoint

release “Met primary endpoint: treatment with LPCN 1148 increased L3 skeletal muscle index (L3-SMI) relative to placebo (P <0.01)” lipocine.com ↗

release “LPCN 1148 Phase 2 study in patients with cirrhosis. The study met primary and hepatic encephalopathy endpoints” lipocine.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LPCN 1148	Unknown	—	Oral

Indications