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NCT04685993 · ClinicalTrials.gov registry record · Phase 2
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
A Phase 2 study of NASH - Nonalcoholic Steatohepatitis, sponsored by Lipocine.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 10
- Study locations
NCT04685993: Completed Phase 2 study of NASH - Nonalcoholic Steatohepatitis, sponsored by Lipocine.
NCT04685993 is a Phase 2 study of NASH - Nonalcoholic Steatohepatitis that has completed, run by Lipocine. The registered enrollment target is 25 participants, below the 261-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (90% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04685993, a Phase 2 study of NASH - Nonalcoholic Steatohepatitis, has completed, sponsored by Lipocine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
Number of subjects presenting with a treatment-emergent adverse events
Conditions Studied
Interventions
- DRUG LPCN 1144
Study Locations (10)
Texas
- R&H Clinical Research - Katy
- Sun Research Institute - San Antonio
- Endeavor Clinical Trials - San Antonio
- Pioneer Research Soultions - Sugar Land
Utah
- Advanced Clinical Research - Gut Whisperer - Riverton
- Granger Medical Clinic - West Valley City
California
- Clinical Trials Research - Roseville
Florida
- Sensible Healthcare, LLC - Ocoee
Nevada
- Jubilee Clinical Research, Inc. - Las Vegas
Virginia
- Manassas Clinical Research Center - Manassas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-11-11 |
| Est. Completion | 2022-03-01 |
| Phase | Phase 2 |
What the finished NCT04685993 record still lists
NCT04685993 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 261-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (90% lower).
The record links to 1 condition, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 1 intervention - of which LPCN 1144 is the first listed.
NCT04685993 lists 10 locations in 6 states (Texas, Utah, California).
Frequently Asked Questions
What is clinical trial NCT04685993 about?
NCT04685993 is a clinical study titled "A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial". 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.
What is the current status of trial NCT04685993?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2020-11-11. Estimated completion is 2022-03-01.
What conditions does trial NCT04685993 study?
This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT04685993?
The interventions under investigation include: LPCN 1144 (DRUG).
Who is sponsoring clinical trial NCT04685993?
This trial is sponsored by Lipocine, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04685993 being conducted?
This trial has 10 study locations across California, Florida, Nevada, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04685993's enrollment target sits among peer trials
25 26th of 28 higher than 3 of 28 other NASH - Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NASH - Nonalcoholic Steatohepatitis 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.
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