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PPAR agonist
Lanifibranor for Nonalcoholic Steatohepatitis (NASH) (NATiV3 Trial)
Verified Trial
Phase 3
Recruiting
Led By Arun J Sanyal, MD
Research Sponsored by Inventiva Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
You have been diagnosed with Nonalcoholic Steatohepatitis
Be older than 18 years old
Timeline
Screening 90 days
Treatment 72 weeks
Follow Up 3 days
Awards & highlights
Pivotal Trial
Summary
This trial is testing a new drug, lanifibranor, to see if it can treat adults with a fatty liver disease called NASH, and who also have liver fibrosis stage 2 or 3.
Who is the study for?
Adults diagnosed with Non-Alcoholic Steatohepatitis (NASH) and liver fibrosis stages F2 or F3 can join. They must have stable doses of certain diabetes medications for 3 months, a steatosis score ≥1, activity score A3 or A4, and agree to a liver biopsy. Excluded are those with other liver conditions like cirrhosis, alcoholic liver disease, chronic hepatitis B/C, Wilson's disease, iron overload, prior transplant or who had weight loss surgery.
What is being tested?
The trial is testing Lanifibranor (IVA337), comparing it against a placebo in adults with NASH and significant scarring of the liver (fibrosis). Participants will be randomly assigned to receive either the drug or placebo to assess its effectiveness and safety.
What are the potential side effects?
While specific side effects for Lanifibranor aren't listed here, similar drugs may cause digestive issues, fatigue, headaches, skin reactions and potential changes in blood tests related to the liver.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 90 days12 visits
Treatment ~ 72 weeks1 visit
Follow Up ~ 3 days5 visits
Screening ~ 90 days
Treatment ~ 72 weeks
Follow Up ~3 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Resolution of NASH and improvement of fibrosis
Safety Analyses
Side effects data
From 2020 Phase 2 trial • 247 Patients • NCT0300807010%
Diarrhoea
10%
Nausea
10%
Weight increased
6%
Oedema peripheral
6%
Transaminases increased
5%
Headache
4%
Fatigue
4%
Constipation
4%
Viral upper respiratory tract infection
2%
Dizziness
1%
Undifferentiated connective tissue disease
1%
Pancreatitis
1%
Post procedural haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
IVA337 800mg
Placebo
IVA337 1200mg
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Lanifibranor (IVA 337) (800 mg/day)Experimental Treatment2 Interventions
2 Lanifibranor tablets 400mg + 1 Placebo to match tablet with food --> once a day (quaque die, QD)
Group II: Lanifibranor (IVA 337) (1200 mg/day)Experimental Treatment1 Intervention
3 Lanifibranor tablets 400mg with food --> once a day (quaque die, QD)
Group III: Matching placeboPlacebo Group1 Intervention
3 Placebo to match tablets with food --> once a day (quaque die, QD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IVA337
2015
Completed Phase 2
~440
Placebo
1995
Completed Phase 3
~2670
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Inventiva PharmaLead Sponsor
7 Previous Clinical Trials
10,618 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
417 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Arun J Sanyal, MDPrincipal InvestigatorVCU Health, Gastroenterology Hepatology and Nutrition, 1200 West Broad Street, Richmond VA23298, USA
4 Previous Clinical Trials
1,780 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
Sven Francque, MDPrincipal InvestigatorDivision of Gastroenterology and Hepatology, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem, Belgium
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My medications have been the same for the last 3 months.I have been on a stable dose of my diabetes medication for at least 3 months.I have no liver conditions other than NASH or fatty liver.I have had weight loss surgery.I have been diagnosed with conditions related to NASH/Fatty Liver, such as obesity, high cholesterol, high triglycerides, high blood pressure, or Type 2 Diabetes.I have been taking the same dose of Vitamin E (400 IU/day or more) for at least 6 months.I have been diagnosed with NASH or Fatty Liver Disease.
Research Study Groups:
This trial has the following groups:- Group 1: Matching placebo
- Group 2: Lanifibranor (IVA 337) (800 mg/day)
- Group 3: Lanifibranor (IVA 337) (1200 mg/day)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 90 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 72 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04849728 — Phase 3
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