Miami Dade Medical Research Institute | Miami, FL
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This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
Full description
Primary objectives
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage F2 or F3 and consists of 2 sequential parts - an initial double-blind placebo-controlled (DBPC) period (Part A) followed by a double-blind active treatment extension (ATE) period (Part B), with the following primary objectives:
Part A To assess the safety and efficacy of lanifibranor compared to placebo on 'NASH resolution and improvement of fibrosis' assessed by liver histology.
Part B To assess the safety of lanifibranor beyond the DBPC period. Secondary objectives
Key secondary objectives of Part 1:
Other secondary objectives of both Part 1 and Part 2:
Enrollment
Sex
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Inclusion and exclusion criteria
Prescreening Criteria:
Inclusion Criteria:
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):
No qualitative change in dose for the drugs listed below:
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.
Exclusion Criteria:
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)
General safety:
Women currently breastfeeding
Previous exposure to lanifibranor
Participation in any clinical trial investigational medicinal product/device within 3 months from Screening or 5 half-lives from Screening, whichever is longer
Concomitant treatment with PPAR-alpha agonists (fibrates)
Primary purpose
Allocation
Interventional model
Masking
1,000 participants in 3 patient groups, including a placebo group
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Central trial contact
Pascaline Clerc
Data sourced from clinicaltrials.gov
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