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 ) (NCT04849728)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Male or female, aged ≥18 years at the time of signing informed consent
2. Upon central biopsy reading process: diagnosis of NASH according to the Steatosis-Activity-Fibrosis (SAF):
3. Steatosis score ≥1
4. Activity score: A3 or A4
5. Fibrosis score: F2 or F3
6. No qualitative change in dose for the drugs listed below:
7. Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2 inhibitors): for at least 3 months
8. Vitamin E (if at a dose ≥400 IU/day): for at least 6 months
9. Statins: for at least 3 months
10. No qualitative change in dose for all other chronically administered drugs for at least 3 months prior to Screening
11. Weight stable for 6 months prior to Screening and between the qualifying liver biopsy and Baseline (no more than 5% change for both periods)
12. Negative serum pregnancy test at study Screening for females of childbearing potential confirmed by central laboratory. Females of childbearing potential must practice a consistent and proper use of highly effective method of contraception throughout the study and for 1 month after treatment discontinuation.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (459 Sites)

• Objective Health - Birmingham Gastroenterology Associates — Birmingham, Alabama
• Digestive Health Specialist of the Southeast — Dothan, Alabama
• North Alabama GI Research Center llc — Madison, Alabama
• The Institute For Liver Health - Chandler — Chandler, Arizona
• Arizona Liver Health - Peoria — Peoria, Arizona
• Dignity Health - St. Joseph's Hospital and Medical Center — Phoenix, Arizona
• Saint Joseph's Hospital and Medical Center — Phoenix, Arizona
• Adobe Gastroenterology — Tucson, Arizona
• Arizona Liver Health — Tucson, Arizona
• ARcare Center for Clinical Research - Conway — Conway, Arkansas
• ARcare Center for Clinical Research — Little Rock, Arkansas
• Arkansas Diagnostic Center — Little Rock, Arkansas
• Arkansas Gastroenterology — North Little Rock, Arkansas
• Summit - Arkansas Gastroenterology — North Little Rock, Arkansas
• Fomatmedicalresearch — Camarillo, California
• GW Research — Chula Vista, California
• Velocity Clinical Research, Chula Vista — Chula Vista, California
• TriWest Research Associates — El Cajon, California
• Cure Clinical Research, LLC — Fountain Valley, California
• SC Clinical Research — Garden Grove, California
• Velocity Clinical Research - Gardena — Gardena, California
• National Research Institute - Santa Ana — Huntington Park, California
• The Clinical Trials Network - Gastro Care Institute — Lancaster, California
• National Research Institute - Westlake — Los Angeles, California
• National Research Institute - Panorama City — Panorama City, California

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.