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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 is a Phase 2 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 64 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00501592
The ClinicalTrials.gov registry entry for NCT00501592 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intercept Pharmaceuticals, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00501592 reports 0 study locations.
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.
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