At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
LPCN 1144drug
Likely dose
LPCN 1144 450 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating LPCN 1144 for NASH - Nonalcoholic Steatohepatitis. Completed, enrolled 25 participants across 10 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNASH - Nonalcoholic Steatohepatitis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartNov 2020
First PostedDec 2020
Primary CompletionMar 2022
TodayJul 2026
First PostedDec 28, 2020
Enrollment StartNov 11, 2020
Primary CompletionMar 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.5 years ago
Interventions
LPCN 1144drug
Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).