StudyFinder
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 )
Recruiting
18 years and over
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
• 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.
• 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)
• 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:
• 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.
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)
Drug: IVA337, Drug: Placebo
NASH - Nonalcoholic Steatohepatitis
Phase III, Nonalcoholic Steatohepatitis, NASH, Peroxisome proliferator-activated receptor (PPAR), Liver Diseases, Fibrosis
Pascaline Clerc - clinical.contact@inventivapharma.com
Luketic, Velimir, A
Phase 3
HM20024140
NCT04849728
See this study on ClinicalTrials.gov