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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04849728 | A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 ) | PHASE3 | ACTIVE NOT_RECRUITING | 1,000 | — | — | Aug 19, 2021 | Sep 30, 2027 | May 20, 2026 | 459 | United States, Argentina +22 |
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.
| 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) |
| 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. |
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...