Active — Not RecruitingPhase 3

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 )

United States, Argentina, Australia1,000 participantsStarted 2021-08-19

Plain-language summary

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Exclusion criteria

. Documented causes of chronic liver disease other than NASH
. Histologically documented liver cirrhosis (fibrosis stage F4)
. History or current diagnosis of hepatocellular carcinoma (HCC)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Resolution of NASH and improvement of fibrosis

Timeframe: Part A: Date of randomisation until the date of biopsy at Week 72

Safety Analyses

Timeframe: 48 weeks after completion of DBPC period

Trial details

NCT IDNCT04849728

SponsorInventiva Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09-30

View on ClinicalTrials.gov More NASH - Nonalcoholic Steatohepatitis trials