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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04849728




Registration number
NCT04849728
Ethics application status
Date submitted
16/04/2021
Date registered
19/04/2021
Date last updated
26/01/2024

Titles & IDs
Public title
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 )
Scientific title
A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) and Fibrosis Stages F2 and F3
Secondary ID [1] 0 0
337HNAS20011
Universal Trial Number (UTN)
Trial acronym
NATiV3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NASH - Nonalcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IVA337
Treatment: Drugs - Placebo

Experimental: Lanifibranor (IVA 337) (800 mg/day) - 2 Lanifibranor tablets 400mg + 1 Placebo to match tablet with food --> once a day (quaque die, QD)

Experimental: Lanifibranor (IVA 337) (1200 mg/day) - 3 Lanifibranor tablets 400mg with food --> once a day (quaque die, QD)

Placebo Comparator: Matching placebo - 3 Placebo to match tablets with food --> once a day (quaque die, QD)


Treatment: Drugs: IVA337
A total of 1000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part A and Part B.

Treatment: Drugs: Placebo
A total of 1000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part A and Part B.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Resolution of NASH and improvement of fibrosis
Timepoint [1] 0 0
Part A: Date of randomisation until the date of biopsy at Week 72
Primary outcome [2] 0 0
Safety Analyses
Timepoint [2] 0 0
48 weeks after completion of DBPC period

Eligibility
Key inclusion criteria
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



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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
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Campbelltown Hospital - Liverpool
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Liverpool Hospital - Liverpool
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John Hunter Hospital - New Lambton
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Nepean Hospital - Penrith
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Gallipoli Medical Research Foundation - Greenslopes
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Royal Brisbane and Women's Hospital - Herston
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Eastern Health - Australia - Box Hill
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Monash Medical Centre - Clayton
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Austin Health - Heidelberg
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Fiona Stanley Hospital - Murdoch
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Royal Perth Hospital - Perth
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2139 - Concord
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2170 - Liverpool
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2305 - New Lambton
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2750 - Penrith
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4120 - Greenslopes
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4029 - Herston
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3128 - Box Hill
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3168 - Clayton
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3084 - Heidelberg
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6150 - Murdoch
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6000 - Perth
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Badalona
Country [197] 0 0
Spain
State/province [197] 0 0
León
Country [198] 0 0
Spain
State/province [198] 0 0
Málaga
Country [199] 0 0
Spain
State/province [199] 0 0
Pontevedra
Country [200] 0 0
Spain
State/province [200] 0 0
Sevilla
Country [201] 0 0
Spain
State/province [201] 0 0
Valencia
Country [202] 0 0
Spain
State/province [202] 0 0
Valladolid
Country [203] 0 0
Spain
State/province [203] 0 0
Zaragoza
Country [204] 0 0
Ukraine
State/province [204] 0 0
Kyiv
Country [205] 0 0
United Kingdom
State/province [205] 0 0
England
Country [206] 0 0
United Kingdom
State/province [206] 0 0
North Lanarkshire
Country [207] 0 0
United Kingdom
State/province [207] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Inventiva Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver
fibrosis histological stage F2 or F3
Trial website
https://clinicaltrials.gov/ct2/show/NCT04849728
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Arun J Sanyal, MD
Address 0 0
VCU Health, Gastroenterology Hepatology and Nutrition, 1200 West Broad Street, Richmond VA23298, USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pascaline Clerc
Address 0 0
Country 0 0
Phone 0 0
2024998937/0644637545
Fax 0 0
Email 0 0
clinical.contact@inventivapharma.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04849728