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.
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 (IVA337) (800 mg/day) | EXPERIMENTAL | 2 Lanifibranor tablets 400 mg with food --\> once a day (quaque die, QD) |
| Lanifibranor (IVA337) (800 mg/day) plus Empagliflozin (10mg/day) | EXPERIMENTAL | 2 Lanifibranor tablets 400 mg plus 1 Empagliflozin tablet 10mg with food --\> once a day (quaque die, QD) |
| 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. |
| 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...