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 States1,000 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

Age range18 Years

SexALL

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

✓. 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

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

NCT IDNCT04849728

SponsorInventiva Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-30