Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IVA337 · 4 trials · 5 indications
Part A: DBPC: Resolution of NASH and improvement of fibrosis at Week 72, defined by NASH CRN scores for ballooning of 0 and inflammation of 0 to 1, and fibrosis score ≥1 stage decrease compared to Baseline
Part B: ATE: * Using the DBPC on-treatment period, comparing the 2 active arms versus placebo * Using the DBPC +ATE on treatment periods, assessing the 2 active arms. For adverse events, adjudicated liver events, and DILI and MACE events, in addition to the raw cumulative incidence proportions, the exposure-adjusted incidence rates will be provided based on the time patients are at risk.
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
SAF-A is the activity part of the Steatosis Activity Fibrosis \[SAF\] histological score, calculated as the sum of lobular inflamation score and balloning score. No worsening of fibrosis means that the CRN fibrosis score (CRN-F) remains stable or decreases.
Mean change of the MRSS from baseline
| Arm | Type | Description |
|---|---|---|
| Lanifibranor (IVA 337) (800 mg/day) | EXPERIMENTAL | 2 Lanifibranor tablets 400mg + 1 Placebo to match tablet with food --\> once a day (quaque die, QD) |
| Lanifibranor (IVA 337) (1200 mg/day) | EXPERIMENTAL | 3 Lanifibranor tablets 400mg with food --\> once a day (quaque die, QD) |
| Matching placebo | PLACEBO_COMPARATOR | 3 Placebo to match tablets with food --\> once a day (quaque die, QD) |
| 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. |
| 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 |
| IVA337 1200mg | EXPERIMENTAL | IVA337 400mg, once a day (Quaque Die, QD) with food |
| IVA337 800mg | EXPERIMENTAL | IVA337 400mg, once a day (Quaque Die, QD) with food |
| Placebo | PLACEBO_COMPARATOR | Placebo to match, once a day (Quaque Die, QD) with food |
| Name | Type | Description |
|---|---|---|
| IVA337 | DRUG | A total of 1000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part A and Part B. |
| Placebo | DRUG | A total of 1000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part A and Part B. |
| Lanifibranor | DRUG | 800 mg |
| Empagliflozin | DRUG | 10 mg |
Prescreening Criteria: * Diagnosed with NASH on prior liver biopsy * Type 2 diabetes with high waist circumference or obesity or hepatic steatosis on ultrasound * At least 3 of the components of metabolic syndrome Inclusion Criteria: 1. Male or female, aged ≥18 years at the time of signing inform...
IVA337, also known as lanifibranor, is being developed for nonalcoholic steatohepatitis (NASH), including NASH with fibrosis and NASH with type 2 diabetes, and for diffuse cutaneous systemic sclerosis (scleroderma). It is an investigational small molecule and has not been approved for any indication.
IVA337 (lanifibranor) targets PPARα, PPARδ, and PPARγ, acting as a pan-PPAR agonist. By engaging all three peroxisome proliferator-activated receptor subtypes, it is designed to address metabolic and fibrotic pathways relevant to NASH and systemic sclerosis.
IVA337, or lanifibranor, is being developed by Inventiva S.A., whose American Depositary Shares trade on the Nasdaq under the ticker IVA. Inventiva is the sponsor of the clinical program evaluating the drug in NASH and diffuse cutaneous systemic sclerosis.
IVA337 (lanifibranor) is in Phase 3 development. The pivotal NATiV3 trial in NASH with fibrosis stages F2 and F3 is active and no longer recruiting, while earlier Phase 2 studies in NASH and diffuse cutaneous systemic sclerosis have been completed. It remains investigational.
IVA337 has been studied in four trials. The Phase 3 NATiV3 study (NCT04849728) is active not recruiting in NASH with F2 and F3 fibrosis. Completed trials include the Phase 2b NASH study NCT03008070, the Phase 2 scleroderma study NCT02503644, and the Phase 2 NASH with type 2 diabetes study NCT05232071.
Yes, IVA337 and lanifibranor are the same investigational compound. IVA337 is the earlier code name used in Phase 2 studies such as NCT03008070 and NCT02503644, while lanifibranor is the name used in the Phase 3 NATiV3 trial and the Phase 2 combination study with empagliflozin.