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NCT00794716 · ClinicalTrials.gov registry record · Phase 2
PK of NRL972 in Patients with Nonalcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD)
A Phase 2 study, sponsored by Norgine.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
NCT00794716: Completed Phase 2 study, sponsored by Norgine.
NCT00794716 is a Phase 2 study that has completed, run by Norgine. The registered enrollment target is 125 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00794716, a Phase 2 study, has completed, sponsored by Norgine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
Study Summary
This study is to evaluate the predictive value of NRL972 pharmacokinetics in the diagnosis of steatohepatitis using fatty liver disease as the comparator group. In addition, the sensitivity and specificity of NRL972 pharmacokinetics as a diagnostic tool will be compared to results from the standard laboratory tests, elastography, tests of metabolic markers and serum fibrosis markers frequently used in the evaluation of clinically predicted NAFLD patients. Patients will be included if they have clinical evidence of fatty liver disease and have been referred to the clinic for a diagnostic work-up, including a liver biopsy, blood tests and scans of the liver.
Primary Outcome
The primary efficacy variable was the NRL972 fractional retention ratio for 10 and 30 minutes post-dose (C30/C10) for different populations with NAFLD.
Interventions
- DRUG NRL972
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2008-06 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT00794716 record still lists
NCT00794716 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which NRL972 is the first listed.
NCT00794716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00794716 about?
NCT00794716 is a clinical study titled "PK of NRL972 in Patients with Nonalcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD)". This study is to evaluate the predictive value of NRL972 pharmacokinetics in the diagnosis of steatohepatitis using fatty liver disease as the comparator group. In addition, the sensitivity and specificity of NRL972 pharmacokinetics as a diagnostic tool will be compared to results from the standard ...
What is the current status of trial NCT00794716?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2008-06. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00794716?
The interventions under investigation include: NRL972 (DRUG).
Who is sponsoring clinical trial NCT00794716?
This trial is sponsored by Norgine, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00794716's enrollment target sits among peer trials
125 558th of 2000 higher than 1,437 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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