Overview

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11%, patients may be enrolled who have been withdrawn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.