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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 is a Phase 2 study that has completed, run by Lipocine. The registered enrollment target is 56 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04134091
The ClinicalTrials.gov registry entry for NCT04134091 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lipocine, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04134091 reports 0 study locations.
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.
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