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NCT00650546 · ClinicalTrials.gov registry record · Phase 2
Role of Exenatide in NASH-a Pilot Study
A Phase 2 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT00650546: Completed Phase 2 study, sponsored by Indiana University.
NCT00650546 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00650546, a Phase 2 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
We hypothesize that exenatide (Byetta), a GLP-1 agonist administered subcutaneously for 24-28 weeks improves liver histology in diabetic patients with biopsy-proven NASH.
Primary Outcome
Number of patients with liver histology improved with exenatide. The improvement of liver histology was defined as (1) no worsening of the fibrosis score, (11) improved score by at least one point in hepatocyte ballooning, and (111) either (a) improvement in NAS (NAFLD Activity Score) by two points spread across as least two of the three NAS components, or by (B)post-treatment NAS\<3.
Interventions
- DRUG Exenatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2006-08 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT00650546 record still lists
NCT00650546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Exenatide is the first listed.
NCT00650546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00650546 about?
NCT00650546 is a clinical study titled "Role of Exenatide in NASH-a Pilot Study". We hypothesize that exenatide (Byetta), a GLP-1 agonist administered subcutaneously for 24-28 weeks improves liver histology in diabetic patients with biopsy-proven NASH.
What is the current status of trial NCT00650546?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2006-08. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00650546?
The interventions under investigation include: Exenatide (DRUG).
Who is sponsoring clinical trial NCT00650546?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00650546's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 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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