Clinical Trial Details

Trial ID: L0129
Source ID: NCT01265498
Associated Drug: Obeticholic Acid
Title: The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)
Acronym: FLINT
Status: Completed
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT01265498/results
Conditions: Nonalcoholic Fatty Liver Disease (NAFLD)|Nonalcoholic Steatohepatitis (NASH)
Interventions: Drug: obeticholic acid|Drug: placebo
Outcome Measures: Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)|Resolution of NASH Diagnosis|Fibrosis: Patient With Improvement|Fibrosis: Change in Score|Total NAFLD Activity Score: Change in Score|Hepatocellular Ballooning: Patients With Improvement|Hepatocellular Ballooning: Change in Score|Steatosis: Patients With Improvement|Steatosis: Change in Score|Lobular Inflammation: Patients With Improvement|Lobular Inflammation: Change in Score|Portal Inflammation: Patients With Improvement|Portal Inflammation: Change in Score|Change in Alanine Aminotransferase|Change in Asparate Aminotransferase|Change in Alkaline Phosphatase|Change in ??-glutamyl Transpeptidase|Change in Total Bilirubin|Change in Total Cholesterol|Change in HDL Cholesterol|Change in LDL Cholesterol|Change in Triglycerides|Change in Haemoglobin|Change in Haematocrit|Change in Mean Corpuscular Volume|Change in White Blood Cell Count|Change in Platelet Count|Change in Bicarbonate|Change in Calcium|Change in Phosphate|Change in Creatinine|Change in Uric Acid|Change in Albumin|Change in Total Protein|Change in Prothrombin Time|Change in International Normalised Ratio|Change in Fasting Serum Glucose|Change in Insulin|Change in HOMA-IR|Change in Glycated Haemoglobin A1c|Change in Weight|Change in Body-mass Index|Change in Waist Circumference|Change in Waist-to-hip Ratio|Change in Systolic Blood Pressure|Change in Diastolic Blood Pressure|Change in SF-36 Quality of Life Physical Component Summary|Change in SF-36 Quality of Life Mental Component Summary
Sponsor/Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 283
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
Start Date: March 2011
Completion Date: September 2014
Results First Posted: August 21, 2015
Last Update Posted: April 6, 2018
Locations: University of California, San Diego, San Diego, California, United States|University of California, San Francisco, San Francisco, California, United States|Indiana University, Indianapolis, Indiana, United States|St. Louis University, Saint Louis, Missouri, United States|Duke University Medical Center, Durham, North Carolina, United States|Case Western Reserve University, Cleveland, Ohio, United States|Cleveland Clinic Foundation, Cleveland, Ohio, United States|Virginia Commonwealth University, Richmond, Virginia, United States|Virginia Mason Medical Center, Seattle, Washington, United States
URL: https://ClinicalTrials.gov/show/NCT01265498

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D248 Obeticholic Acid Chemical drug DB05990 NR1H4 activator; NR1H4 agonist; FXR agonist Enhance lipid metabolism Approval rejected Details
D055 Calcium Chemical drug DB01373 CAST; COMP; CP; BMP4; MGP -- Under clinical trials Details
D094 Cysteamine Chemical drug DB00847 GSS stimulant Renal drug Under clinical trials Details
D095 Cysteamine bitartrate Chemical drug DB00847 -- -- Under clinical trials Details
D182 Insulin Biological drug DB00030 INSR agonist; CPE modulator&product of -- Under clinical trials Details
D199 L-alanine Chemical drug DB00160 KYNU -- Failed in clinical trials Details
D328 Serine Chemical drug DB00133 SRR Improve insulin resistance Under clinical trials Details