Study of INT-747 in Patients With Diabetes and Presumed NAFLD

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intercept Pharmaceuticals
• Treatments: Chenodeoxycholic Acid

Criteria

Inclusion Criteria:

• Type 2 diabetes, defined by the American Diabetes Association (ADA), as one of the following criteria:

• Symptoms of diabetes plus casual plasma glucose concentration >200 mg/dL (11.1 mmol/L) or

• Fasting plasma glucose >126 mg/dL (7.0 mmol/L) or

• 2-hour post-load glucose >200 mg/dL (11.1 mmol/L) during a 75 g oral glucose tolerance test (GTT).

• Presumed NAFLD, defined by one of the following criteria:

• Alanine aminotransferase (ALT) ≥47 U/L for females and ≥56 U/L for males

• Aspartate aminotransferase (AST) ≥47 U/L for females and ≥60 U/L for males

• Enlarged liver (demonstrated by ultrasound or other imaging technique)

• Diagnostic histological findings shown on prior biopsy (in the last 5 years).

Exclusion Criteria:

• Bilirubin >2 × ULN

• ALT >155 U/L for females and >185 U/L for males.

• AST >155 U/L for females and >200 U/L for males.

• Patients taking any antidiabetic medications, with the exception of metformin and sulfonylureas. If the HbA1c is <11%, patients may be enrolled who have been withdrawn from all other diabetic medications as specified in the protocol, at the discretion of the Principal Investigator.