Evaluating lanifibranor for treating NASH with liver fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 study evaluates the efficacy and safety of lanifibranor in adults diagnosed with Nonalcoholic Steatohepatitis (NASH) and liver fibrosis stages F2 or F3. The study consists of two parts: an initial double-blind placebo-controlled period followed by an active treatment extension. The primary objectives include assessing NASH resolution and improvement of fibrosis through liver histology. Secondary objectives focus on various health parameters, including liver tests and quality of life assessments.

Why it matters

Who can join: the full rules

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 informed consent
2. Upon central biopsy reading process: diagnosis of NASH according to the Steatosis-Activity-Fibrosis (SAF):

   1. Steatosis score ≥1
   2. Activity score: A3 or A4
   3. Fibrosis score: F2 or F3
3. No qualitative change in dose for the drugs listed below:

   1. 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
   2. Vitamin E (if at a dose ≥400 IU/day): for at least 6 months
   3. Statins: for at least 3 months
4. No qualitative change in dose for all other chronically administered drugs for at least 3 months prior to Screening
5. Weight stable for 6 months prior to Screening and between the qualifying liver biopsy and Baseline (no more than 5% change for both periods)
6. 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.

Exclusion Criteria:

Liver-related:

1. Documented causes of chronic liver disease other than NASH
2. Histologically documented liver cirrhosis (fibrosis stage F4)
3. History or current diagnosis of hepatocellular carcinoma (HCC)
4. History of or planned liver transplant
5. Positive human immunodeficiency virus (HIV) serology
6. ALT or AST \>5 × ULN
7. AST\<0.6 ULN if the liver biopsy has to be performed in the scope of the study
8. Abnormal synthetic liver function as defined by Screening central laboratory evaluation
9. Haemoglobin \<110 g/L (11 g/dL) for females and \<120 g/L (12 g/dL) for males
10. Patient currently receiving any approved treatment for NASH or obesity
11. Current or recent history (\<5 years) of significant alcohol consumption
12. 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:
13. HbA1c \>9% at Screening
14. Diabetes mellitus other than type 2
15. Current treatment with insulin
16. Treatment with PPAR-gamma agonists (thiazolidinediones \[TZDs\]) 12 months before screening or historical biopsy.

    Obesity related:
17. 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:
18. History of heart failure with reduced left ventricular ejection fraction (LVEF)
19. Atrial fibrillation requiring anticoagulation
20. Unstable heart failure
21. Uncontrolled hypertension at Screening (values \>160/100 mm Hg)

    General safety:
22. Women currently breastfeeding
23. Previous exposure to lanifibranor
24. Participation in any clinical trial investigational medicinal product/device within 3 months from Screening or 5 half-lives from Screening, whichever is longer
25. Concomitant treatment with PPAR-alpha agonists (fibrates)

Where it's running

• Pinnacle Research Group
  Anniston, Alabama, United States Recruiting
• Objective Health - Birmingham Gastroenterology Associates
  Birmingham, Alabama, United States Recruiting
• Digestive Health Specialist of the Southeast
  Dothan, Alabama, United States Recruiting
• North Alabama GI Research Center llc
  Madison, Alabama, United States Recruiting
• The Institute For Liver Health - Chandler
  Chandler, Arizona, United States Recruiting
• Arizona Liver Health - Peoria
  Peoria, Arizona, United States Recruiting

+444 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Arun J Sanyal, MD — VCU Health, Gastroenterology Hepatology and Nutrition, 1200 West Broad Street, Richmond VA23298, USA
• Study coordinator: Pascaline Clerc
• Email: clinical.contact@inventivapharma.com
• Phone: 2024998937/0644637545

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.