NCT04685993

A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial

An Open Label Extension Study of the Safety and Tolerability of LPCN 1144 for the Treatment of Subjects With Nonalcoholic Steatohepatitis (NASH) Who Have Completed the LPCN 1144-18-002 Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Lipocine Inc. · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.

Detailed description

This is a multicenter, open-label extension protocol to provide LPCN 1144, an investigational drug, to subjects with NASH who have completed the LPCN 1144-18-002 protocol. Enrolled subjects will be given LPCN 1144 for up to 36 weeks. Subjects will be seen periodically to evaluate safety clinical laboratory tests, tolerability of LPCN 1144, adverse events, and overall subject health. Subjects will be given the option of having a liver biopsy performed at Week 36.

Conditions

• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	LPCN 1144	Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).

Timeline

• Start date: 2020-11-11
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2020-12-28
• Last updated: 2024-07-17
• Results posted: 2024-07-17

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study