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NCT00501592 · ClinicalTrials.gov registry record · Phase 2
Study of INT-747 in Patients With Diabetes and Presumed NAFLD
A Phase 2 study, sponsored by Intercept Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT00501592: Completed Phase 2 study, sponsored by Intercept Pharmaceuticals.
NCT00501592 is a Phase 2 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00501592, a Phase 2 study, has completed, sponsored by Intercept Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following: * The safety and tolerability of multiple doses of INT 747; * The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and glucose homeostasis; * Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function and inflammation, and; * Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic acid (6-EDCA) and tauro 6-ECDCA.
Primary Outcome
The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline (Day 0) and at the end of 6 weeks of treatment (Day 43).
Interventions
- DRUG Placebo
- DRUG INT-747
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2007-07 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
What the finished NCT00501592 record still lists
NCT00501592 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00501592 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00501592 about?
NCT00501592 is a clinical study titled "Study of INT-747 in Patients With Diabetes and Presumed NAFLD". The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following: * The safety and tolerability of multiple doses of INT 747; * The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin...
What is the current status of trial NCT00501592?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2007-07. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00501592?
The interventions under investigation include: Placebo (DRUG), INT-747 (DRUG).
Who is sponsoring clinical trial NCT00501592?
This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00501592's enrollment target sits among peer trials
64 996th of 2000 higher than 992 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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