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Also known as IVA 337
Lanifibranor · 3 trials · 5 indications
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.
Effect of lanifibranor alone compared to placebo and the effect of lanifibranor in combination with empagliflozin compared to placebo on absolute change in HbA1c from baseline (Week 0) to Week 24
| 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. |
| Lanifibranor (800 mg/day) | EXPERIMENTAL | Lanifibranor (800 mg/day): two film-coated tablets of 400 mg each, once-a-day (QD) with food. For oral use. QD for 24 weeks. |
| Matching placebo | PLACEBO_COMPARATOR | Two lanifibranor placebo-matching tablets once-a-day (QD) with food. For oral use. QD for 24 weeks. |
| Lanifibranor (800 mg/day) plus Empagliflozin (10mg/day) | EXPERIMENTAL | Lanifibranor (800 mg/day): two film-coated tablets of 400 mg each plus one empagliflozin film-coated tablet of 10 mg (10mg/day), once-a-day (QD) with food. For oral use. QD for 24 weeks |
| Experimental | EXPERIMENTAL | IMP Under investigation |
| Placebo to Match | PLACEBO_COMPARATOR | - |
| 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. |
| Empagliflozin | DRUG | 10 mg |
| Moxifloxacin | DRUG | Single oral dose at D-8 |
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...
Lanifibranor is an investigational oral small molecule developed by Inventiva S.A. for metabolic liver diseases, including nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD). It is a pan-PPAR agonist that has received FDA Breakthrough Therapy and Fast Track designations. It has been studied in completed Phase 1 and Phase 2 clinical trials.
Lanifibranor is being developed to treat nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD), including patients with type 2 diabetes. Clinical studies have evaluated it in these liver conditions, and it holds FDA Breakthrough Therapy and Fast Track designations for its development in NASH.
Lanifibranor targets PPARG, PPARA, and PPARD, making it a pan-PPAR agonist. By activating all three peroxisome proliferator-activated receptor subtypes, it is designed to address metabolic and inflammatory pathways relevant to NASH and NAFLD. This triple agonist mechanism distinguishes it from single or dual PPAR agents.
Lanifibranor is being developed by Inventiva S.A., whose American Depositary Shares trade under the ticker IVA. The company has advanced the compound through completed Phase 1 and Phase 2 trials in healthy subjects and in patients with NASH, NAFLD, and type 2 diabetes.
Lanifibranor has completed Phase 1 and Phase 2 clinical development. It is an investigational drug and is not approved for commercial use. Its clinical program includes a Phase 1 multiple ascending dose study in healthy subjects and Phase 2 studies in NASH, NAFLD, and type 2 diabetes.
Completed trials include NCT05232071, a Phase 2 proof-of-concept study of Lanifibranor alone and with empagliflozin in NASH patients with type 2 diabetes; NCT03866369, a Phase 1 multiple ascending dose study in healthy male subjects; and NCT03459079, a Phase 2 study in patients with NAFLD and type 2 diabetes.