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NCT04134091 · ClinicalTrials.gov registry record · Phase 2
The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis
A Phase 2 study, sponsored by Lipocine.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT04134091: Completed Phase 2 study, sponsored by Lipocine.
NCT04134091 is a Phase 2 study that has completed, run by Lipocine. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04134091, a Phase 2 study, has completed, sponsored by Lipocine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH.
Primary Outcome
The change in magnetic resonance imaging derived proton fat fraction (MRI-PDFF) from baseline to week 12 in LPCN 1144 treated subjects and subjects given placebo.
Interventions
- DRUG Placebo
- DRUG LPCN 1144 Formulation A
- DRUG LPCN 1144 Formulation B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2019-08-27 |
| Est. Completion | 2021-06-24 |
| Phase | Phase 2 |
What the finished NCT04134091 record still lists
NCT04134091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04134091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04134091 about?
NCT04134091 is a clinical study titled "The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis". This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH.
What is the current status of trial NCT04134091?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2019-08-27. Estimated completion is 2021-06-24.
What interventions are being tested in trial NCT04134091?
The interventions under investigation include: Placebo (DRUG), LPCN 1144 Formulation A (DRUG), LPCN 1144 Formulation B (DRUG).
Who is sponsoring clinical trial NCT04134091?
This trial is sponsored by Lipocine, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04134091's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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