| Trial ID: | L0507 |
| Source ID: | NCT03459079
|
| Associated Drug: |
Lanifibranor
|
| Title: |
Efficacy, Safety and Mechanism of Action of Lanifibranor (IVA337) in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Fatty Liver Disease (NAFLD);Type 2 Diabetes (T2DM)
|
| Interventions: |
Drug: Lanifibranor;Other: Placebo
|
| Outcome Measures: |
Change in intrahepatic triglycerides (IHTG) quantified by proton magnetic resonance and spectroscopy (??H-MRS)Proportion of patients with a decrease from baseline in IHTG (quantified by ??H-MRS) to week 24 of = 30%.;Proportion of patients with NAFLD resolution, defined as having = 5.5% IHTG (quantified by 1H- MRS).;Improvement in hepatic insulin sensitivity and de novo lipogenesis.;Improvement in adipose tissue insulin sensitivity.;Improvement in muscle insulin sensitivity (Rd).;Change in glycemic control (HbA1c).;Change in plasma lipid profile.;Changes in hepatic fibrosis on imaging.;Change in plasma biomarkers of liver fibrosis.
|
| Sponsor/Collaborators: |
University of Florida
|
| Gender: |
All
|
| Age: |
21 Years75 Years
|
| Phases: |
Phase 2
|
| Enrollment: |
44
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
02/03/2018
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
12 April 2021
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03459079
|
