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NCT04849728 · ClinicalTrials.gov record · last posted 2026-07-02

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 )

Study acronym: NATiV3
StatusActive, Not Recruiting
PhasePhase 3
Started2021-08-19
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3

Protocol amendment history 6 changes detected by DataLookout

2026-05-21
minor
Trial sites expanded: 434 → 459 locations
2026-05-21
notable
Primary completion pushed: 2027-06-30 → 2027-09-30
2026-05-21
minor
Completion pushed: 2027-06-30 → 2027-09-30
2026-05-16
minor
Trial sites expanded: 428 → 434 locations
2026-05-16
critical
Primary completion pushed: 2026-12-30 → 2027-06-30
2026-05-16
minor
Completion pushed: 2026-12-30 → 2027-06-30
Trial Details
NCT Number NCT04849728
Lead Sponsor Inventiva Pharma
Conditions NASH - Nonalcoholic Steatohepatitis
Enrollment 1,000 participants
Start Date 2021-08-19
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-02