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NCT03436420 · ClinicalTrials.gov registry record · Phase 2
Gemcabene for the Treatment of Pediatric NAFLD
A Phase 2 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT03436420: Clinical Trial Phase 2 study, sponsored by Emory University.
NCT03436420 is a Phase 2 study that was terminated before completion, run by Emory University. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03436420, a Phase 2 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a multicenter, prospective, open-label, Phase 2, proof of concept study to test preliminary efficacy and safety of gemcabene in children with established nonalcoholic fatty liver disease (NAFLD) incompletely treated by lifestyle changes. The hypothesis of the study is that 300 mg of gemcabene once a day for 12 weeks will reduce alanine aminotransferase (ALT), hepatic steatosis, dyslipidemia and down regulate de novo lipogenesis in children with NAFLD.
Primary Outcome
Percent change in alanine aminotransferase (ALT) from baseline to 12 weeks was examined. ALT elevation is the most common screening test used for detecting NAFLD. The normal range for ALT varies by age, sex, and the specific assay used but is approximately 9-23 units/Liter (U/L) for boys and girls aged 1-18. Children with a sustained ALT ≥ 80 U/L are twice as likely to have nonalcoholic steatohepatitis (NASH), which is a severe form of NAFLD characterized by inflammation and liver cell damage.
Interventions
- DRUG Gemcabene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-03-29 |
| Est. Completion | 2019-08-27 |
| Phase | Phase 2 |
Why NCT03436420 stopped before completion
NCT03436420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Gemcabene is the first listed.
NCT03436420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03436420 about?
NCT03436420 is a clinical study titled "Gemcabene for the Treatment of Pediatric NAFLD". This is a multicenter, prospective, open-label, Phase 2, proof of concept study to test preliminary efficacy and safety of gemcabene in children with established nonalcoholic fatty liver disease (NAFLD) incompletely treated by lifestyle changes. The hypothesis of the study is that 300 mg of gemcaben...
What is the current status of trial NCT03436420?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2018-03-29. Estimated completion is 2019-08-27.
What interventions are being tested in trial NCT03436420?
The interventions under investigation include: Gemcabene (DRUG).
Who is sponsoring clinical trial NCT03436420?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03436420's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 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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