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NCT04849728 · ClinicalTrials.gov registry record · Phase 3
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 )
A Phase 3 study of NASH - Nonalcoholic Steatohepatitis, sponsored by Inventiva Pharma.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,000
- Enrollment target
- 20
- Study locations
NCT04849728: Recruiting Phase 3 study of NASH - Nonalcoholic Steatohepatitis, sponsored by Inventiva Pharma.
NCT04849728 is a Phase 3 study of NASH - Nonalcoholic Steatohepatitis that is actively recruiting participants, run by Inventiva Pharma. The registered enrollment target is 1,000 participants, above the 226-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (342% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04849728, a Phase 3 study of NASH - Nonalcoholic Steatohepatitis, is actively recruiting participants, sponsored by Inventiva Pharma.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG IVA337
Study Locations (20)
Arizona
- The Institute For Liver Health - Chandler - Chandler
- Arizona Liver Health - Peoria - Peoria
- Saint Joseph's Hospital and Medical Center - Phoenix
- Arizona Digestive Health - Sun City - Tucson
- Adobe Gastroenterology - Tucson
- Arizona Liver Health - Tucson
- Del Sol Research Management - Tucson East - Tucson
California
- Office of Franco Felizarta, MD - Bakersfield
- Fomatmedicalresearch - Camarillo
- Precision Research Institute - Chula Vista
- GW Research - Chula Vista
- Velocity Clinical Research, Chula Vista - Chula Vista
Alabama
- Pinnacle Research Group - Anniston
- Objective Health - Birmingham Gastroenterology Associates - Birmingham
- Digestive Health Specialist of the Southeast - Dothan
- North Alabama GI Research Center llc - Madison
Arkansas
- ARcare Center for Clinical Research - Conway - Conway
- ARcare Center for Clinical Research - Little Rock
- Arkansas Diagnostic Center - Little Rock
- Arkansas Gastroenterology - North Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2021-08-19 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 3 |
What NCT04849728 shows while recruiting
NCT04849728 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 226-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (342% higher).
The record links to 1 condition, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04849728 names 20 study sites across 4 states, led by Arizona, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT04849728 about?
NCT04849728 is a clinical study titled "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 )". This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
What is the current status of trial NCT04849728?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2021-08-19. Estimated completion is 2026-09-30.
What conditions does trial NCT04849728 study?
This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT04849728?
The interventions under investigation include: Placebo (DRUG), IVA337 (DRUG).
Who is sponsoring clinical trial NCT04849728?
This trial is sponsored by Inventiva Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04849728 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for NASH - Nonalcoholic Steatohepatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04849728's enrollment target sits among peer trials
1,000 3rd of 28 higher than 26 of 28 other NASH - Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NASH - Nonalcoholic Steatohepatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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