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PPAR agonist

Lanifibranor for Nonalcoholic Steatohepatitis (NASH) (NATiV3 Trial)

Verified Trial
Phase 3
Recruiting
Led By Sven Francque, MD
Research Sponsored by Inventiva Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All other chronically administered drugs must be stable for at least 3 months prior to Screening
Be older than 18 years old
Timeline
Screening 90 days
Treatment 72 weeks
Follow Up 3 days
Awards & highlights
Pivotal Trial

NATiV3 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.Check my eligibility
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.See study design
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.

NATiV3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My medications have been the same for the last 3 months.

NATiV3 Trial Timeline

Screening ~ 90 days
Treatment ~ 72 weeks
Follow Up ~3 days
This trial's timeline: 90 days for screening, 72 weeks for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Resolution of NASH and improvement of fibrosis
Safety Analyses

Side effects data

From 2020 Phase 2 trial • 247 Patients • NCT03008070
10%
Weight increased
10%
Diarrhoea
10%
Nausea
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.

NATiV3 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
Placebo
1995
Completed Phase 3
~2670
IVA337
2015
Completed Phase 2
~400

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
6 Previous Clinical Trials
618 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
417 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Sven Francque, MDPrincipal InvestigatorDivision of Gastroenterology and Hepatology, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem, Belgium
Arun J Sanyal, MDPrincipal InvestigatorVCU Health, Gastroenterology Hepatology and Nutrition, 1200 West Broad Street, Richmond VA23298, USA
3 Previous Clinical Trials
80 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease

Media Library

Lanifibranor (PPAR agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04849728 — Phase 3
Non-alcoholic Fatty Liver Disease Research Study Groups: Matching placebo, Lanifibranor (IVA 337) (800 mg/day), Lanifibranor (IVA 337) (1200 mg/day)
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Lanifibranor Highlights & Side Effects. Trial Name: NCT04849728 — Phase 3
Lanifibranor (PPAR agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04849728 — Phase 3
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04849728 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still able to add new participants to this research project?

"Yes, according to the latest information available on clinicaltrials.gov, this study is still actively recruiting patients. The trial was initially posted on August 19th, 2021 and edited September 7th, 2022. They are 2000 patients needed across 100 different locations."

Answered by AI

Are there any other existing research projects that have used IVA337?

"The initial study for IVA337 was done in 2018 at University of Florida. However, as of right now, there have been a total of 18266 completed trials. Additionally, there are 2 live studies being conducted with a large number taking place in Hagerstown, Maryland."

Answered by AI

Have researchers looked into this topic before?

"Inventiva Pharma sponsored the first trial for IVA337 back in 2018, which then allowed the Phase 2 drug approval for the medication. Since then, there have been 2 live studies involving IVA337 that are running in 207 cities and 22 countries."

Answered by AI

Has the FDA cleared IVA337 for medical use?

"There is both prior clinical data and supporting data from multiple rounds of testing, so the Power team has given IVA337 a score of 3 for safety."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
New York
Other
California
How old are they?
18 - 65
65+
What site did they apply to?
California Liver Reearch
National Research Institute - Westlake
National Research Institute - Panorama City
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0

What questions have other patients asked about this trial?

How early I can start? How does this trail work ? How long is this trial going?
PatientReceived 2+ prior treatments
Are there any overnight stays required? How long does the clinical trials usually last?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

To improve my health. To help to find a cure. Looking for future cure. told i have fatty liver.
PatientReceived no prior treatments
Extremely high cholesterol.
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Tampa Bay Medical Research: < 24 hours
  2. National Research Institute - Panorama City: < 24 hours
  3. University of Chicago: < 48 hours
~388 spots leftby Sep 2025