Overview

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

Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Intercept Pharmaceuticals
Treatments:
Chenodeoxycholic Acid