A Phase 3 Study Evaluating Long-term Efficacy and Safety of Lanifibranor in Adult Patients With (NASH) and Fibrosis 2 (F2)/Fibrosis 3 (F3) Stage of Liver Fibrosis

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of lanifibranor (800 mg and 1200 mg administered once daily) compared to placebo in adult patients with NASH and F2/F3 liver fibrosis.
 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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. Stable 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): Stable dose for at least 3 months

2. Vitamin E (if at a dose ≥400 IU/day): Stable dose for at least 6 months

3. Statins: Stable dose for at least 3 months

4. All other chronically administered drugs must be stable 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. Abnormal synthetic liver function as defined by Screening central laboratory
evaluation

8. Haemoglobin <110 g/L (11 g/dL) for females and <120 g/L (12 g/dL) for males

9. Patient currently receiving any approved treatment for NASH or obesity

10. Current or recent history (<5 years) of significant alcohol consumption

11. 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:

12. HbA1c >9% at Screening

13. Diabetes mellitus other than type 2

14. Current treatment with insulin

15. Previous or current treatment with PPAR-gamma agonists (thiazolidinediones [TZDs])

Obesity related:

16. 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:

17. History of heart failure with reduced left ventricular ejection fraction (LVEF)

18. Atrial fibrillation requiring anticoagulation

19. Unstable heart failure

20. Uncontrolled hypertension at Screening (values >160/100 mm Hg)

General safety:

21. Women currently breastfeeding

22. Previous exposure to lanifibranor

23. Participation in any clinical trial investigational medicinal product/device within 3
months from Screening or 5 half-lives from Screening, whichever is longer

24. Concomitant treatment with PPAR-alpha agonists (fibrates)

Eligibility last updated 7/13/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Harmeet Malhi, M.B.B.S.

Contact us for the latest status

Contact information:

Harmeet Malhi M.B.B.S.

(507) 293-1537

Malhi.Harmeet@mayo.edu

More information

Publications

Publications are currently not available