CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
INT-747 +1 moredrug
Likely dose
INT-747 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00501592
NCT00501592Phase 2Completed
CompareCT.gov

An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease

Intercept Pharmaceuticals·interventional·Posted Jul 16, 2007·Updated Apr 20, 2012

In Brief

A Phase 2 clinical trial evaluating INT-747 and Placebo for Diabetes Mellitus, Type II and Fatty Liver. Completed, enrolled 64 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type II, Fatty Liver
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 16, 2007
Enrollment StartJul 1, 2007
Primary CompletionFeb 1, 2009
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.0 years ago

Interventions

INT-747drug

25 mg by mouth once daily, 50 mg by mouth once daily

Placebodrug

Placebo