| Trial ID: | L0602 |
| Source ID: | NCT03451279
|
| Associated Drug: |
A4250
|
| Title: |
Use of A4250, a Nonabsorbable Ileal Apical Sodium-Dependent Bile Acid Transporter Inhibitor for Nonalcoholic Steatohepatitis (BRAVO-1)
|
| Acronym: |
BRAVO-1
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis (NASH);Nonalcoholic Fatty Liver Disease (NAFLD)
|
| Interventions: |
Drug: A4250;Drug: Placebo
|
| Outcome Measures: |
Change in serum alanine aminotransferase (ALT) levelsChange in gamma-glutamyl transpeptidase (GGT) levels;Change in aspartate aminotransferase (AST) levels;Change in HOMA-IR levels;Change in fasting serum LDL cholesterol level;Change in hepatic steatosis as evaluated by Fibroscan??;Change in hepatic stiffness measurements by Fibroscan??;Change in fasting serum HDL cholesterol
|
| Sponsor/Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
All
|
| Age: |
18 Yearsnan
|
| Phases: |
Phase 2
|
| Enrollment: |
0
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
| Start Date: |
08/09/2015
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
26 March 2018
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03451279
|
