Status:
RECRUITING
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 )
Lead Sponsor:
Inventiva Pharma
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
Detailed 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-...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
August 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04849728
Start Date
August 19 2021
End Date
September 30 2026
Last Update
January 26 2024
Active Locations (494)
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1
Pinnacle Research Group
Anniston, Alabama, United States, 36207
2
Objective Health - Birmingham Gastroenterology Associates
Birmingham, Alabama, United States, 35209
3
Digestive Health Specialist of the Southeast
Dothan, Alabama, United States, 36305
4
North Alabama GI Research Center llc
Madison, Alabama, United States, 60602