Fatty Liver Clinical Trial
Official title:
An Exploratory Study of INT-747 in Patients With Type 2 Diabetes Mellitus and Presumed Nonalcoholic Fatty Liver Disease
Verified date | April 2012 |
Source | Intercept Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | April 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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11%, patients may be enrolled who have been withdrawn from all other diabetic medications as specified in the protocol, at the discretion of the Principal Investigator. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Profil Institute for Clinical Research, Inc. | Chula Vista | California |
United States | Virginia Commonwelath University | Richmond | Virginia |
United States | Diabetes & Glandular Disease Research Associates, Inc. | San Antonio | Texas |
United States | UC San Diego VAMC | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Intercept Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Insulin Resistance and Glucose Homeostasis | 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). | baseline and 6 weeks | No |
Secondary | Hepatocellular Function | Hepatocellular function as measured by assessment of liver enzymes and biochemical markers of hepatic and metabolic function | baseline and 6 weeks | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05979779 -
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis
|
Phase 2 | |
Recruiting |
NCT06051669 -
Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US
|
||
Not yet recruiting |
NCT05984745 -
Effect of CoQ10 on the Outcome of MAFLD Patients
|
Phase 2 | |
Completed |
NCT02565446 -
Transforming Non-Invasive Liver Disease Detection by MRE: The Hepatogram
|
N/A | |
Not yet recruiting |
NCT01694342 -
Telomere Parameters in Patients With Nonalcoholic Fatty Liver
|
N/A | |
Completed |
NCT01464801 -
Resveratrol in Patients With Non-alcoholic Fatty Liver Disease
|
N/A | |
Completed |
NCT01992809 -
Omega 3 Supplementation in Fatty Liver
|
Phase 3 | |
Completed |
NCT00244569 -
Development of a Breath Test for Monitoring Patients With Liver Disease
|
Phase 3 | |
Completed |
NCT00063635 -
Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
|
Phase 3 | |
Recruiting |
NCT03972319 -
Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study
|
Early Phase 1 | |
Completed |
NCT03141008 -
Evaluation of Liver and Cardiometabolic Health Benefits on Low Carbohydrate Ketogenic Diet
|
||
Completed |
NCT03614039 -
Effect of Probiotic and Smectite Gel on NAFLD
|
N/A | |
Recruiting |
NCT05125757 -
Lifestyle Modification in Psoriatic Patients With Fatty Liver
|
N/A | |
Recruiting |
NCT05370053 -
The Availability of the Enhanced Liver Fibrosis (ELF) Test Affects the Rate of Diagnosis of Nonalcoholic Steatohepatitis (NASH) With Fibrosis in Patients Referred to Hepatology
|
N/A | |
Recruiting |
NCT04371042 -
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
|
||
Completed |
NCT04004273 -
Diabetes, Exercise and Liver Fat (DELIVER)
|
N/A | |
Completed |
NCT02520609 -
Dynamic Post-Prandial Metabolism in Patients With Non-Alcoholic Fatty Liver Disease
|
||
Recruiting |
NCT02265276 -
A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease
|
Phase 3 | |
Completed |
NCT02347007 -
Impact of Almond Supplementation on Body Composition in Overweight/Obese Minority Adults
|
N/A | |
Completed |
NCT01934777 -
Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis
|
Phase 3 |