Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501592
Status:
COMPLETED
Last Update Posted:
2012-04-20
First Post:
2007-07-13
Brief Title:
Study of INT-747 in Patients With Diabetes and Presumed NAFLD
Sponsor:
Intercept Pharmaceuticals
Organization:
Intercept Pharmaceuticals
Study Overview
Official Title:
An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This is a multi-center double-blind randomized placebo-controlled multiple-dose parallel-group study Three 3 cohorts of 12 patients each will receive either placebo 25 mg INT-747 or 50 mg INT-747 by mouth daily for 6 weeks
The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline Day 0 and at the end of 6 weeks of treatment Day 43 Other endpoints will be evaluated by monitoring adverse experiences vital signs clinical laboratory values plasma drug and metabolite concentrations and general health and well-being
The primary objective of assessing changes in insulin resistance and glucose homeostasis will be attained by performing a euglycemic clamp procedure at baseline Day 0 and at the end of 6 weeks of treatment Day 43 Other endpoints will be evaluated by monitoring adverse experiences vital signs clinical laboratory values plasma drug and metabolite concentrations and general health and well-being
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None