ClinicalTrials.gg
CompletedNCT05232071LEGENDUpdated Sep 9, 2026Results posted

Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus

A Phase 2 interventional study of Lanifibranor and Placebo in NASH - Nonalcoholic Steatohepatitis and Diabetes Mellitus, Type 2, sponsored by Inventiva Pharma. Completed at 42 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Inventiva Pharma · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • NASH - Nonalcoholic Steatohepatitis
  • Diabetes Mellitus, Type 2
03

In context

Non-alcoholic Fatty Liver Disease

1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.

This study's enrollment of 39 is below the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Inventiva Pharma is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female, aged ≥ 18 years at the time of signing
  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. 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 or at least two-year .

Exclusion criteria

Exclusion Criteria:

Liver-related:

  1. Documented causes of chronic liver disease other than NASH
  2. 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 (HIV) infection
  6. or AST > 5 × (ULN)
  7. Abnormal liver function as defined by central laboratory evaluation:

    Albumin \< LLN ≥ 1.3 (unless patient is on anticoagulants) Total 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. \< 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. 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. >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

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 (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 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 medicinal product/device within 3 months from Screening or five half-lives of the investigational drug from Screening.

Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Lanifibranor (800 mg/day)

    Lanifibranor (800 mg/day): two film-coated tablets of 400 mg each, once-a-day (QD) with food. For oral use. QD for 24 weeks.

    Drug: Lanifibranor

  • Placebo comparator
    Matching placebo

    Two lanifibranor placebo-matching tablets once-a-day (QD) with food. For oral use. QD for 24 weeks.

    Drug: Placebo

  • Experimental
    Lanifibranor (800 mg/day) plus Empagliflozin (10mg/day)

    Lanifibranor (800 mg/day): two film-coated tablets of 400 mg each plus one empagliflozin film-coated tablet of 10 mg (10mg/day), once-a-day (QD) with food. For oral use. QD for 24 weeks

    Drug: Lanifibranor · Drug: Empagliflozin

Interventions

06

What researchers measure

Primary outcomes

  1. Absolute Change in HbA1c

    Effect of lanifibranor alone compared to placebo and the effect of lanifibranor in combination with empagliflozin compared to placebo on absolute change in HbA1c from baseline (Week 0) to Week 24

    Time frame: From Baseline to Week 24

Secondary outcomes

  1. Change in Liver Tests (ALT)

    Defined as Absolute Change from Baseline

    Time frame: from Baseline to Week 24

  2. Change in Liver Tests (AST)

    Defined as Absolute Change from Baseline

    Time frame: from Baseline to Week 24

  3. Percentage Change in Insulin Resistance and Glycaemic Control (HOMA-IR)

    HOMA-IR : The homeostatic model assessment for insulin resistance (HOMA-IR) is a method used to quantify insulin resistance, and was derived by the central laboratory from glucose and insulin values using the formula (Fasting glucose mg/dL x fasting insulin µIU/mL) / 405. Lower values are considered better outcome.

    Time frame: from Baseline to Week 24

  4. Change in Insulin Resistance and Glycaemic Control (Insulin)

    Defined as Relative Change from Baseline

    Time frame: from Baseline to Week 24

  5. Change in Insulin Resistance and Glycaemic Control (Adiponectin)

    Defined as Fold Change from Baseline

    Time frame: from Baseline to Week 24

  6. Change in Lipid Parameters (HDL Cholesterol)

    Defined as Relative Change

    Time frame: from Baseline to Week 24

  7. Change in Body Weight and Body Composition (Body Weight)

    Defined as Relative Change from Baseline

    Time frame: from Baseline to Week 24

  8. Change in Body Weight and Body Composition (VAT/SAT Ratio)

    Ratio VAT / SAT - Results for Relative Change from Baseline VAT : MRI L3 visceral adipose tissue SAT : MRI L3 subcutaneous adipose tissue

    Time frame: from Baseline to Week 24

07

Results

Posted Sep 9, 2026
Limitations and caveats
No multiplicity adjustments when testing for treatment effect on secondary endpoints.

Participant flow

Recruitment of patients started in June 2022 and last patient was recruited in November 2023. A total of 213 patients were screened for the study.

Participant flow — Overall Study
MilestoneLanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)Placebo
Started121314
Completed12129
Not completed015
Withdrew: Non compliance with study drug001
Withdrew: Lost to follow-up002
Withdrew: Withdrawal by subject002
Withdrew: Adverse event010

Outcome measures

PrimaryAbsolute Change in HbA1c

Effect of lanifibranor alone compared to placebo and the effect of lanifibranor in combination with empagliflozin compared to placebo on absolute change in HbA1c from baseline (Week 0) to Week 24

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · percentage of glycosylated hemoglobin
Absolute Change in HbA1c
percentage of glycosylated hemoglobinLanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)Placebo
Absolute Change in HbA1c-1.11 (-1.6 to -0.62)-1.54 (-2.02 to -1.06)0.16 (-0.32 to 0.63)
Statistical analysis
  • Lanifibranor (800 mg/Day) vs Placebo · Mixed Models Analysis · p = < 0.001 · Ls mean difference (lsm): -1.27 · 95% CI -1.95 to -0.58mixed model for repeated measures (MMRM)
  • Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day) vs Placebo · Mixed Models Analysis · p = < 0.001 · Ls mean difference (lsm): -1.7 · 95% CI -2.38 to -1.02mixed model for repeated measures (MMRM)
SecondaryChange in Liver Tests (ALT)

Defined as Absolute Change from Baseline

Time frame:
from Baseline to Week 24
Reported as:
Least squares mean · Absolute Change (U/L)
Change in Liver Tests (ALT)
Absolute Change (U/L)Lanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)Placebo
Change in Liver Tests (ALT)-26.60 (-38.08 to -15.12)-29.63 (-42.13 to -17.13)-5.65 (-17.89 to 6.59)
SecondaryChange in Liver Tests (AST)

Defined as Absolute Change from Baseline

Time frame:
from Baseline to Week 24
Reported as:
Least squares mean · Absolute Change (U/L)
Change in Liver Tests (AST)
Absolute Change (U/L)Lanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)Placebo
Change in Liver Tests (AST)-13.67 (-20.66 to -6.68)-17.81 (-25.5 to -10.12)1.3 (-6.11 to 8.71)
SecondaryPercentage Change in Insulin Resistance and Glycaemic Control (HOMA-IR)

HOMA-IR : The homeostatic model assessment for insulin resistance (HOMA-IR) is a method used to quantify insulin resistance, and was derived by the central laboratory from glucose and insulin values using the formula (Fasting glucose mg/dL x fasting insulin µIU/mL) / 405. Lower values are considered better outcome.

Time frame:
from Baseline to Week 24
Reported as:
Least squares mean · Percentage change
Percentage Change in Insulin Resistance and Glycaemic Control (HOMA-IR)
Percentage changeLanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)Placebo
Percentage Change in Insulin Resistance and Glycaemic Control (HOMA-IR)-50.79 (-95.69 to -5.89)-45.23 (-89.86 to -0.61)35.01 (-10.29 to 80.32)
SecondaryChange in Insulin Resistance and Glycaemic Control (Insulin)

Defined as Relative Change from Baseline

Time frame:
from Baseline to Week 24
Reported as:
Least squares mean · Percentage Change
Change in Insulin Resistance and Glycaemic Control (Insulin)
Percentage ChangeLanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)Placebo
Change in Insulin Resistance and Glycaemic Control (Insulin)-33.48 (-68.24 to 1.28)-38.16 (-72.16 to -4.16)10.17 (-23.63 to 43.96)
SecondaryChange in Insulin Resistance and Glycaemic Control (Adiponectin)

Defined as Fold Change from Baseline

Time frame:
from Baseline to Week 24
Reported as:
Least squares mean · Fold Change
Change in Insulin Resistance and Glycaemic Control (Adiponectin)
Fold ChangeLanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)Placebo
Change in Insulin Resistance and Glycaemic Control (Adiponectin)2.87 (2.05 to 3.68)3.03 (2.18 to 3.89)1.24 (0.39 to 2.09)
SecondaryChange in Lipid Parameters (HDL Cholesterol)

Defined as Relative Change

Time frame:
from Baseline to Week 24
Reported as:
Least squares mean · Relative Change (%)
Change in Lipid Parameters (HDL Cholesterol)
Relative Change (%)Lanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)Placebo
Change in Lipid Parameters (HDL Cholesterol)16.48 (5.24 to 27.72)15.30 (3.04 to 27.56)2.55 (-9.76 to 14.86)
SecondaryChange in Body Weight and Body Composition (Body Weight)

Defined as Relative Change from Baseline

Time frame:
from Baseline to Week 24
Reported as:
Least squares mean · Relative Change (%)
Change in Body Weight and Body Composition (Body Weight)
Relative Change (%)Lanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)Placebo
Change in Body Weight and Body Composition (Body Weight)3.6 (2 to 5.19)0.25 (-1.50 to 2.01)-1.16 (-2.84 to 0.53)
SecondaryChange in Body Weight and Body Composition (VAT/SAT Ratio)

Ratio VAT / SAT - Results for Relative Change from Baseline VAT : MRI L3 visceral adipose tissue SAT : MRI L3 subcutaneous adipose tissue

Time frame:
from Baseline to Week 24
Reported as:
Least squares mean · Relative Change (%)
Change in Body Weight and Body Composition (VAT/SAT Ratio)
Relative Change (%)Lanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)Placebo
Change in Body Weight and Body Composition (VAT/SAT Ratio)-4.6 (-14.44 to 5.25)-17.45 (-28.67 to -6.23)2.01 (-9.12 to 13.14)

Adverse events

Collected over On or after the first dose of treatment up to 30 days post last dose.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lanifibranor (800 mg/Day)0/12 (0%)0/12 (0%)10/12 (83.3%)
Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)0/13 (0%)1/13 (7.7%)9/13 (69.2%)
Placebo0/14 (0%)0/14 (0%)8/14 (57.1%)
Most frequent serious events
Most frequent serious events
EventLanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)Placebo
HaematuriaRenal and urinary disorders0/121/130/14
Most frequent other events
Showing 10 of 57
Most frequent other events
EventLanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)Placebo
AnemiaBlood and lymphatic system disorders2/120/131/14
HeadacheNervous system disorders2/121/130/14
AlopeciaSkin and subcutaneous tissue disorders2/120/130/14
NauseaGastrointestinal disorders1/122/130/14
OverdoseInjury, poisoning and procedural complications1/122/130/14
Diabetes mellitus inadequate controlMetabolism and nutrition disorders0/122/130/14
RashSkin and subcutaneous tissue disorders0/120/132/14
Ear pruritusEar and labyrinth disorders1/120/130/14
Abdominal painGastrointestinal disorders1/120/131/14
ToothacheGastrointestinal disorders1/121/130/14

Baseline characteristics

Thirty-nine (39) took at least 1 dose of treatment and were included in the Full Analysis Set (FAS) and were evaluable for safety (Safety Analysis Set SAS).

Age, Categorical
Age, Categorical(Participants)Lanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)PlaceboTotal
<=18 years0000
Between 18 and 65 years9101029
>=65 years33410
Age, Continuous
Age, Continuous(years)Lanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)PlaceboTotal
Mean55.1 ± 11.4554.2 ± 13.4854.7 ± 13.0154.6 ± 12.38
Sex: Female, Male
Sex: Female, Male(Participants)Lanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)PlaceboTotal
Female68721
Male65718
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Lanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)PlaceboTotal
American Indian or Alaska Native0011
Asian1337
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White1010929
More than one race0000
Unknown or Not Reported1012
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Lanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)PlaceboTotal
Hispanic or Latino74718
Not Hispanic or Latino59721
Unknown or Not Reported0000
HbA1c
HbA1c(Participants)Lanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)PlaceboTotal
<7.5%45514
≥7.5%88925
Weight
Weight(Kg)Lanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)PlaceboTotal
Mean93.30 ± 11.614103.30 ± 12.43794.50 ± 21.26997.06 ± 16.213
Height
Height(cm)Lanifibranor (800 mg/Day)Lanifibranor (800 mg/Day) Plus Empagliflozin (10mg/Day)PlaceboTotal
Mean167.08 ± 9.418165.89 ± 8.911164.73 ± 12.072165.84 ± 10.077

1 further baseline measures are reported on the registry.

08

Study locations

42 sites
  • Birmingham Digestive Health Research
    Homewood, Alabama 35209, United States
  • Institute for Liver Health dba Arizona Liver Health
    Chandler, Arizona 85224, United States
  • ARcare Center for Clinical Research
    Conway, Arkansas 72032, United States
  • ARcare Center for Clinical Research
    Little Rock, Arkansas 72205, United States
  • Cure Clinical Research, LLC
    Fountain Valley, California 92708, United States
  • Velocity Clinical Research
    Gardena, California 90247, United States
  • National Research Institute
    Huntington Park, California 90255, United States
  • Cadena Care Institute, LLC
    Poway, California 92064, United States
  • Florida Research Institute
    Lakewood Rch, Florida 34211, United States
  • Galenus Group
    Lehigh Acres, Florida 33936, United States
  • Prolive Medical Research
    Miami, Florida 33175, United States
  • Indiana University School of Medicine
    Indianapolis, Indiana 46202, United States
  • Digestive Health Research of Southern California
    South Bend, Indiana 46635, United States
  • Tandem Clinical Research - New Orleans Area Site
    Marrero, Louisiana 70072, United States
  • Harvard Medical School
    Boston, Massachusetts 02115, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • AIG Digestive Disease Research
    Florham Park, New Jersey 07932, United States
  • Digestive Health Research
    Hermitage, Tennessee 37076, United States
  • Accelemed Research Institute
    Austin, Texas 78745, United States
  • Dallas Diabetes Research Center
    Dallas, Texas 75230, United States
  • American Research Corporation
    San Antonio, Texas 78215, United States
  • Diabetes & Glandular Disease Clinic, P.A.
    San Antonio, Texas 78229, United States
  • Impact Research Institute
    Waco, Texas 76710, United States
  • Digestive Health Research of North Texas
    Wichita Falls, Texas 76301, United States
  • University of Virginia
    Charlottesville, Virginia 22908, United States
  • Central Virginia VA Healthcare System
    Richmond, Virginia 23249, United States
  • CUB Erasme Hospital
    Brussels, 1070, Belgium
  • Cliniques Universitaires Saint-Luc
    Brussels, 1200, Belgium
  • Universitair Ziekenhuis Antwerpen
    Edegem, 2650, Belgium
  • AZ Maria Middelares
    Ghent, 9000, Belgium
  • UZ GENT
    Ghent, 9000, Belgium
  • CHU Angers_Service d'hepatogastro-enterologie
    Angers, 49000, France
  • CHU Limoges
    Limoges, 87042, France
  • Hopital Saint Antoine
    Paris, 75012, France
  • CHU Bordeaux
    Pessac, 33604, France
  • Chu Rangueil
    Toulouse, 31059, France
  • HGE CHRU Nancy
    Vandœuvre-lès-Nancy, 54500, France
  • Amsterdam UMC
    Amsterdam, 1105 AZ, Netherlands
  • Hull University Teaching Hospital
    Hull, HU32JZ, United Kingdom
  • King's College Hospital
    London, SE59RS, United Kingdom
  • St Georges Hospital
    London, SW17 0QT, United Kingdom
  • Royal Victoria Infirmary
    Newcastle upon Tyne, NE1 7RU, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2022 to primary completion in May 2024, 22 months.

Results were first posted in Sep 2026, 2 years 4 months after primary completion.

Of 132 industry-sponsored phase 2 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 30. This study's 22 months is close to that.

Counting every sponsor, half of 185 studies reached it within 26 months; a quarter within 16 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2022
First posted
Feb 9, 2022
StartActual
Jun 29, 2022
Primary completionActual
May 8, 2024
CompletionActual
Jun 4, 2024
Results first posted
Sep 9, 2026
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05232071
Lead sponsor
Inventiva Pharma
Responsible party
Sponsor
First posted
Feb 9, 2022
Start date
Jun 29, 2022
Primary completion
May 8, 2024
Completion
Jun 4, 2024
Results posted
Sep 9, 2026
Last update
Sep 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Lanifibranor

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