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 )

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: NASH - Nonalcoholic Steatohepatitis

In brief

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3

Key facts

Study ID

NCT04849728

Run by

Inventiva Pharma

People needed

1000

Starts

2021-08-19

Expected to finish

2027-09-30

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, aged ≥18 years at the time of signing informed consent
• Upon central biopsy reading process: diagnosis of NASH according to the Steatosis-Activity-Fibrosis (SAF):
• Steatosis score ≥1
• Activity score: A3 or A4
• Fibrosis score: F2 or F3
• No qualitative change in dose for the drugs listed below:
• 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
• Vitamin E (if at a dose ≥400 IU/day): for at least 6 months
• Statins: for at least 3 months
• No qualitative change in dose for all other chronically administered drugs for at least 3 months prior to Screening
• Weight stable for 6 months prior to Screening and between the qualifying liver biopsy and Baseline (no more than 5% change for both periods)
• 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.

You may not qualify if…

• Liver-related:
• Documented causes of chronic liver disease other than NASH
• Histologically documented liver cirrhosis (fibrosis stage F4)
• History or current diagnosis of hepatocellular carcinoma (HCC)
• History of or planned liver transplant
• Positive human immunodeficiency virus (HIV) serology
• ALT or AST >5 × ULN
• AST<0.6 ULN if the liver biopsy has to be performed in the scope of the study
• Abnormal synthetic liver function as defined by Screening central laboratory evaluation
• Haemoglobin <110 g/L (11 g/dL) for females and <120 g/L (12 g/dL) for males
• Patient currently receiving any approved treatment for NASH or obesity
• Current or recent history (<5 years) of significant alcohol consumption
• Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) administered for at least 2 weeks within 12 months prior to qualifying liver biopsy
• Glycaemia related:
• HbA1c >9% at Screening
• Diabetes mellitus other than type 2
• Current treatment with insulin
• Treatment with PPAR-gamma agonists (thiazolidinediones [TZDs]) 12 months before screening or historical biopsy.
• Obesity related:
• Bariatric surgery: Restrictive procedures are allowed, if performed >6 months prior to the qualifying liver biopsy; malabsorptive procedures and procedures combining both restrictive and malabsorptive methods are not allowed within 5 years of the qualifying liver biopsy.
• Cardiovascular related:
• History of heart failure with reduced left ventricular ejection fraction (LVEF)
• Atrial fibrillation requiring anticoagulation
• Unstable heart failure
• Uncontrolled hypertension at Screening (values >160/100 mm Hg)

Where it is running

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

Full record on ClinicalTrials.gov

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