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A Phase 2, Randomized Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia

Trial Profile

A Phase 2, Randomized Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 22 Nov 2024

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At a glance

  • Drugs LPCN 1148 (Primary)
  • Indications Liver cirrhosis; Non-alcoholic steatohepatitis; Sarcopenia
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Lipocine

Most Recent Events

  • 18 Nov 2024 According to a Lipocine media release, Company announced the publication of results from this trial in the journal Hepatology and discussion of a manuscript at The Liver Meeting (AASLD) 2024 Editor's Cut: Clinical Study Session held on November 16, 2024.
  • 08 Aug 2024 According to a Lipocine media release, Research and development expenses were $4.7 million and $5.6 million, respectively, for the six months ended June 30, 2024 and 2023. The decrease was a result of a decrease in contract research organization expense and outside consulting costs related to the wind down of our LPCN 1148 study in 2024.
  • 08 Aug 2024 According to a Lipocine media release, Research and development expenses were $1.9 million and $2.5 million, respectively, for the quarters ended June 30, 2024 and 2023. The decrease was a result of a decrease in contract research organization expense and outside consulting costs related to the wind down of our LPCN 1148 study in 2024.

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