Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03459079 | Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease | PHASE2 | COMPLETED | 128 | — | — | Aug 14, 2018 | Jun 1, 2023 | Sep 19, 2024 | 1 | United States |
Changes from baseline (Adjusted LS means) in absolute percent for change in intrahepatic triglycerides (IHTG) quantified by proton magnetic resonance and spectroscopy (¹H-MRS)are reported in each arms.
| Arm | Type | Description |
|---|---|---|
| lanifibranor arm | ACTIVE_COMPARATOR | Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day. |
| Placebo | PLACEBO_COMPARATOR | Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo. |
| Name | Type | Description |
|---|---|---|
| Lanifibranor | DRUG | The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day |
| Placebo | OTHER | Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo. |
Inclusion Criteria: * Be able to communicate meaningfully with the investigator and legally competent to provide written informed consent * Have an age between 21 to 75 years inclusive * Subjects should be on stable standard of care and background therapy for ongoing chronic conditions, including s...