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A placebo-controlled, proof-of-concept study to evaluate the safety and efficacy of lanifibranor alone and in combination with the sodium-glucose transport protein 2 (SGLT2) inhibitor EmpaGliflozin in patiEnts with non-alcoholic steatohepatitis (NASH) and type 2 diabetes mellitus (T2DM)

NCT ID NCT05232071

NEW Sponsor: Inventiva Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

39 people

The number who actually took part.

Started

Jun 2022

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female, aged ≥ 18 years at the time of signing informed consent 2. Diagnosis of NASH, based on histology or cT1≥875ms assessed by LiverMultiScan or cT1≥825ms assessed by LiverMultiScan and hepatic fat content ≥ 10% assessed by MRI-PDFF at screening 3. HbA1c at screening ≥ 7.0 and ≤ 10.0%, on diet alone, or on metformin and/or dipeptidyl peptidase 4 inhibitor (DPP-IVi) therapy. Both with doses to be stable for 3 months 4. Negative pregnancy test at Screening for females of childbearing potential or at least two-year post-menopausal. 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. Documented history of human immunodeficiency virus (HIV) infection 6. ALT or AST \> 5 × upper limit of normal (ULN) 7. Abnormal liver function as defined by central laboratory evaluation: Albumin \< LLN INR ≥ 1.3 (unless patient is on anticoagulants) Total bilirubin level ≥ 1.5 mg/dL (25.7 µmol/L) (patients with a documented history of Gilbert's syndrome can be enrolled if direct bilirubin is ≤ 0.45 mg/dL (7.7 μmol/L) ) 8. Hemoglobin \< 110 g/L (11 g/dL) for females and \< 120 g/L (12 g/dL) for males 9. WBC \< LLN. A lower count is acceptable in patients with benign ethnic neutropenia, if considered to be clinical insignificant by the investigator 10. Platelet count \< 140,000/µL 11. ALP \> 2 × ULN 12. Patient currently receiving any approved treatment for NASH or obesity 13. Current or recent history (\< 5 years) of significant alcohol consumption 14. Administration of drugs known to produce hepatic steatosis in the 6 months prior to Screening. Diabetes related: 15. Diabetes mellitus other than type 2 16. Diabetic ketoacidosis at Screening 17. Current treatment with glucagon-like peptide-1 receptor agonists (GLP-1RA), insulin or sulfonylurea or treatment within the last 3 months prior to Screening 18. Patients on pioglitazone in the last 12 months prior to Screening. 19. Patients on metformin, DPP-IVi, thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels, unless on stable doses in last 3 months Obesity related: 20. BMI\>45 kg/m2 at screening 21. Introduction of an anti-obesity drug or restrictive bariatric surgery in the past 12 months prior to Screening or planned bariatric surgery through Week 24. Cardiovascular related: 21\. History of or current unstable cardiac dysrhythmias 22. Unstable heart failure 23. Uncontrolled hypertension 24. Stroke or transient ischemic attack General safety: 25\. Significant systemic or major illnesses other than liver disease and pulmonary disease, organ transplantation, serious psychiatric disease, that, in the opinion of the investigator, would preclude treatment with lanifibranor and/or adequate follow up 26. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value \< 60 mL/min 27. Concomitant treatment with PPAR-⍺ agonists (fibrates) 28. Patients on Vitamin E at doses ≥ 400 IU/day; doses of ≥ 400 IU/day are allowed when no qualitative change in dose for 6 months prior to Screening 29. Have a known hypersensitivity to any of the IMPs 30. Previous exposure to lanifibranor or empagliflozin 31. Present pregnancy/lactation 32. Metallic implant of any sort that prevents MRI examination 33. Participation in any clinical trial of an approved or non approved investigational medicinal product/device within 3 months from Screening or five half-lives of the investigational drug from Screening.

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 2 NASH - nonalcoholic steatohepatitis

Contacts and locations

Locations

  • AIG Digestive Disease Research

    Florham Park, New Jersey, 07932, United States

  • ARcare Center for Clinical Research

    Conway, Arkansas, 72032, United States

  • ARcare Center for Clinical Research

    Little Rock, Arkansas, 72205, United States

  • AZ Maria Middelares

    Ghent, 9000, Belgium

  • Accelemed Research Institute

    Austin, Texas, 78745, United States

  • American Research Corporation

    San Antonio, Texas, 78215, United States

  • Amsterdam UMC

    Amsterdam, 1105 AZ, Netherlands

  • Birmingham Digestive Health Research

    Homewood, Alabama, 35209, United States

  • CHU Angers_Service d'hepatogastro-enterologie

    Angers, 49000, France

  • CHU Bordeaux

    Pessac, 33604, France

  • CHU Limoges

    Limoges, 87042, France

  • CUB Erasme Hospital

    Brussels, 1070, Belgium

  • Cadena Care Institute, LLC

    Poway, California, 92064, United States

  • Central Virginia VA Healthcare System

    Richmond, Virginia, 23249, United States

  • Chu Rangueil

    Toulouse, 31059, France

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Cure Clinical Research, LLC

    Fountain Valley, California, 92708, United States

  • Dallas Diabetes Research Center

    Dallas, Texas, 75230, United States

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas, 78229, United States

  • Digestive Health Research

    Hermitage, Tennessee, 37076, United States

  • Digestive Health Research of North Texas

    Wichita Falls, Texas, 76301, United States

  • Digestive Health Research of Southern California

    South Bend, Indiana, 46635, United States

  • Florida Research Institute

    Lakewood Rch, Florida, 34211, United States

  • Galenus Group

    Lehigh Acres, Florida, 33936, United States

  • HGE CHRU Nancy

    Vandœuvre-lès-Nancy, 54500, France

  • Harvard Medical School

    Boston, Massachusetts, 02115, United States

  • Hopital Saint Antoine

    Paris, 75012, France

  • Hull University Teaching Hospital

    Hull, HU32JZ, United Kingdom

  • Impact Research Institute

    Waco, Texas, 76710, United States

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Institute for Liver Health dba Arizona Liver Health

    Chandler, Arizona, 85224, United States

  • King's College Hospital

    London, SE59RS, United Kingdom

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • National Research Institute

    Huntington Park, California, 90255, United States

  • Prolive Medical Research

    Miami, Florida, 33175, United States

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 7RU, United Kingdom

  • St Georges Hospital

    London, SW17 0QT, United Kingdom

  • Tandem Clinical Research - New Orleans Area Site

    Marrero, Louisiana, 70072, United States

  • UZ GENT

    Ghent, 9000, Belgium

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • Velocity Clinical Research

    Gardena, California, 90247, United States

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