A Phase 2 interventional study of Lanifibranor and Placebo in Nonalcoholic Fatty Liver Disease (NAFLD) and Type 2 Diabetes (T2DM), sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Florida · Phase 2, Interventional, and Treatment
The primary aim is to establish the safety, efficacy and mechanism of action of lanifibranor in patients with type 2 diabetes (T2DM) and nonalcoholic fatty liver disease (NAFLD). Specifically, to determine if lanifibranor decreases intrahepatic triglycerides (IHTG) (primary endpoint), improves hepatic insulin sensitivity, endogenous (hepatic) glucose production, de novo lipogenesis (DNL), HbA1c and lipid profiles. In addition, exploratory analysis with surrogate plasma biomarkers and imaging on liver fibrosis changes on with treatment will be performed.
The study is a two-arm (placebo, lanifibranor 800 mg/day), randomized (1:1), double-blind, placebo-controlled, 24-week treatment study. Thirty four (n=34)patients with T2DM will be randomized, allowing for a 10% drop-out rate. The diagnosis of NAFLD on imaging will be done by measuring IHTG using the gold-standard magnetic resonance and spectroscopy (¹H-MRS) technique. Ten non-diabetic subjects without NAFLD will also serve as a control group for the metabolic and imaging procedures. The study will last 34-36 weeks (\~6-8 weeks for run-in, 24 weeks of treatment and 4 weeks post-study follow-up), with an estimated recruitment period of \~9 months. Patients with uncontrolled T2DM and a diagnosis of "fatty liver" per history (elevated AST/ALT and/or liver fat on liver ultrasound or ¹H-MRS and/or other appropriate imaging technique - see below). Participants may be treated by diet only, or be on a stable dose of metformin and/or a sulfonylurea and/or a DPP-IV inhibitor for ≥ 2 months prior to enrollment. If the HbA1c is ≤8.0% on any of these diabetes medications, the dose of these medications will be kept stable throughout the study and baseline studies performed as outlined below. If the HbA1c is > 8.0% but ≤ 9.5%, metformin (minimum dose required: 1,000 mg/day for metformin) and/or a sulfonylurea (minimum dose required: glimepiride 2 mg once daily) will be added, or doses maximized, during the first 2 weeks of the lead-in period. Afterwards, patient's metformin or sulfonylurea dose will be maintained at the new dose stable for 4 weeks before baseline metabolic and study-specific liver imaging.
After patients sign the informed consent and meet eligibility criteria, baseline imaging and metabolic studies will be performed. These will include measurement of IHTG by 1H-MRS, liver fibrosis by VCTE (Fibroscan) and MRE, and additional imaging by T1 MRI mapping. Metabolic testing will be done with the patient being admitted to the CRC (clinical research unit) for an overnight stay. Assessment of insulin sensitivity and DNL will be done with the administration of stable isotopes of glucose (intravenously) and deuterium labeled water (orally) to measure glucose and lipid turnover and substrate oxidation (with indirect calorimetry) during a euglycemic hyperinsulinemic clamp.
After all baseline tests are completed, patients will be asked to take a therapeutic dose of 800 mg lanifibranor (QD), or placebo, for 24 weeks. They will be closely followed by study staff every 4 weeks with visits to the CRC and interim phone calls. At 24 weeks, all baseline tests will be repeated and treatment considered completed. There will be a final, off-drug, safety follow-up visit 4 weeks after treatment at week 28. After this the participant will have completed all study procedures.
Note: The investigators recalculated the sample size for the primary endpoint of change in intrahepatic triglyceride (IHTG) measured by 1H-MRS with lanifibranor (800 mg/day) vs. placebo based on the data from the population with diabetes from the Phase IIb NATIVE (NCT03008070: NAsh Trial to Validate IVA337 Efficacy; liver histology results) and comparing to prior studies by Dr. Cusi et al that had simultaneous liver histology and liver fat measured by 1H-MRS (Belfort et al, NEJM 2006; Cusi et al, Annals Int Med 2016). From this analysis, the required sample size per group calls for 15 patients in each arm (lanifibranor vs. placebo) to complete treatment. Conservatively assuming that 10 % of the randomized patients will not complete the trial (dropouts), the total number of patients to be randomized is 33-34 patients.
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 128 is above the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Have uncontrolled diabetes with a fasting plasma glucose (FPG) ≥ 100 mg/dL but ≤ 250 mg/dL and ≥ 6.0% but ≤ 9.5%, on diet alone, or on metformin (≥1,000 mg/day), and/or sulfonylurea and/or DPP-IV therapy, SGLT2 inhibitors or GLP1RA. These medicines will be continued at stable doses during the entire study.
Compensated liver disease with the following hematologic and biochemical criteria on entry into protocol:
Exclusion Criteria:
Treatment with strong inducers or inhibitors of CYP2C8, or treatment with substrates of CYP2B6 or CYP2C8. When administered chronically, they should be replaced 2 months before trial entry (See Inclusion criterion #3). If not administered chronically, they should be stopped at least 7 days before first dosing.
-Patients with:
i. Unstable angina (i.e., new or worsening symptoms of coronary heart disease within the past 3 months), acute coronary syndrome within the past 6 months, acute myocardial infarction in the past 3 months or heart failure of class (III-IV) or worsening congestive heart failure, or coronary artery intervention, within the past 6 months ii. History of (within prior 3 months) or current unstable cardiac dysrhythmias iii. Uncontrolled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg.
iv. Stroke or within the prior 6 months c. History of in the past 5 years and/or active neoplasm with the exception of resolved superficial nonmelanoma skin cancer d. History of bladder disease and/or hematuria or has current hematuria unless due to a urinary tract infection e. Any of the following laboratory values: ii. Serum > 1.3 mg/dL (or > 22.2 µmol/L). Patients with bilirubin >1.3 mg/dL can be included if non-conjugated bilirubin in the setting of a Gilbert's syndrome.
iii. Serum > 3X iv. > 1.2 v. \< 150,000 per microliter of blood vi. Renal impairment as demonstrated by estimated (eGFR) \< 60 mL/min/1.73m2 vii. Total creatinine kinase > 1.5 X ULN viii. Lipase > 1.3X ULN or >2.0X ULN if on a DPP-IV inhibitor. *(if abnormal values are confirmed when repeated within 3 weeks) ix. > 9.5%
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.
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.
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.
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).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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).
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
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.
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.
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.
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.
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Drug: Lanifibranor
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
Other: Placebo
The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
Also known as: IVA 337
Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
Change in Intrahepatic Triglycerides (IHTG) Quantified by Proton Magnetic Resonance and Spectroscopy (¹H-MRS)
Changes from baseline (Adjusted LS means) in absolute percent for change in intrahepatic triglycerides (IHTG) quantified by proton magnetic resonance and spectroscopy (¹H-MRS)are reported in each arms.
Time frame: 24 weeks of treatment
Percentage of Patients With a Decrease From Baseline in IHTG (Quantified by ¹H-MRS) to Week 24 of ≥ 30%.
Percentage of patients with a decrease from baseline in IHTG (quantified by ¹H-MRS) to week 24 of ≥ 30% in each group.
Time frame: 24 weeks of treatment.
Percentage of Patients With NAFLD Resolution, Defined as Having ≤ 5.5% IHTG (Quantified by 1H- MRS).
Percentage of patients with NAFLD resolution, defined as having ≤ 5.5% IHTG (quantified by 1H- MRS) in both arms.
Time frame: 24 weeks of treatment.
Improvement in Hepatic Insulin Sensitivity (Hepatic Insulin Resistance Index Reported as Relative Percent Change)
Changes from baseline in hepatic insulin sensitivity (Hepatic Insulin Resistance Index) as a relative percent change is presented (i.e. \[24 week result- baseline result\]/baseline result \*100).
Time frame: 24 weeks of treatment.
Improvement in Adipose Tissue Insulin Sensitivity.
Changes from baseline in absolute value of adipose tissue insulin resistance (ADIPO-IR) index will be compared between both arms. This is calculated using the formula below: Adipo-IR index = fasting serum free fatty acid concentration x fasting plasma insulin level. A higher value indicated higher insulin resistance.
Time frame: 24 weeks of treatment.
Improvement in Muscle Insulin Sensitivity (Rd).
Relative percent changes from baseline in insulin-stimulated muscle glucose disposal (%) will be compared between both arms (i.e. \[24 week result- baseline result\]/baseline result \*100).
Time frame: 24 weeks of treatment.
Absolute Change in Glycemic Control (Hemoglobin A1c).
Absolute changes from baseline will be compared between both arms (i.e., percentage at 24 weeks subtracted from the percentage at baseline).
Time frame: 24 weeks of treatment.
Change in Plasma HDL-C (mg/dl).
Changes from baseline will be compared between both arms.
Time frame: 24 weeks of treatment.
Changes in Hepatic Fibrosis (Liver Stiffness Measurement by Vibration Controlled Transient Elastography in kPa) on Imaging.
Changes from baseline in liver stiffness measurement in kPa by vibration controlled transient elastography measured in both arms.
Time frame: 24 weeks of treatment.
Change in Plasma Biomarkers of Liver Fibrosis (Plasma Cytokeratin 18 Measured in IU/L).
Absolute change (Mean ± SD) changes from baseline in plasma cytokeratin 18 (IU/L) levels in both arms.
Time frame: 24 weeks of treatment.
Changes in Hepatic Fibrosis (Liver Stiffness Measurement by Magnetic Resonance Elastography in kPa) on Imaging.
Changes from baseline in liver stiffness measurement by magnetic resonance elastography is measured in both arms (absolute change in kPa from baseline).
Time frame: 24 weeks of treatment.
Hepatic Fibrosis (Liver Stiffness Measurement by Magnetic Resonance Elastography) on Imaging.
Baseline liver stiffness measurement (LSM) by magnetic resonance elastography (in kPa) in both arms.
Time frame: Baseline measurement of liver stiffness by magnetic resonance elastography is reported in each arm.
| Milestone | Lanifibranor Arm | Placebo | Healthy Control Group (Not a Treatment Arm) |
|---|---|---|---|
| Started | 20 | 18 | 10 |
| Completed | 14 | 14 | 10 |
| Not completed | 6 | 4 | 0 |
| Withdrew: Adverse event | 4 | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 2 | 0 |
Changes from baseline (Adjusted LS means) in absolute percent for change in intrahepatic triglycerides (IHTG) quantified by proton magnetic resonance and spectroscopy (¹H-MRS)are reported in each arms.
| percentage decrease from baseline | Lanifibranor Arm | Placebo |
|---|---|---|
| Change in Intrahepatic Triglycerides (IHTG) Quantified by Proton Magnetic Resonance and Spectroscopy (¹H-MRS) | -8.7 (-11.3 to -6.0) | -3.0 (-5.9 to -0.2) |
Percentage of patients with a decrease from baseline in IHTG (quantified by ¹H-MRS) to week 24 of ≥ 30% in each group.
| percentage of participants | Lanifibranor Arm | Placebo |
|---|---|---|
| Percentage of Patients With a Decrease From Baseline in IHTG (Quantified by ¹H-MRS) to Week 24 of ≥ 30%. | 65 (41 to 85) | 22 (6 to 48) |
Percentage of patients with NAFLD resolution, defined as having ≤ 5.5% IHTG (quantified by 1H- MRS) in both arms.
| percentage of participants | Lanifibranor Arm | Placebo |
|---|---|---|
| Percentage of Patients With NAFLD Resolution, Defined as Having ≤ 5.5% IHTG (Quantified by 1H- MRS). | 25 (9 to 49) | 0 (0 to 19) |
Changes from baseline in hepatic insulin sensitivity (Hepatic Insulin Resistance Index) as a relative percent change is presented (i.e. \[24 week result- baseline result\]/baseline result \*100).
| percentage of baseline value | Lanifibranor Arm | Placebo |
|---|---|---|
| Improvement in Hepatic Insulin Sensitivity (Hepatic Insulin Resistance Index Reported as Relative Percent Change) | -26 (-37 to -14) | -7 (-19 to 4) |
Changes from baseline in absolute value of adipose tissue insulin resistance (ADIPO-IR) index will be compared between both arms. This is calculated using the formula below: Adipo-IR index = fasting serum free fatty acid concentration x fasting plasma insulin level. A higher value indicated higher insulin resistance.
| index | Lanifibranor Arm | Placebo |
|---|---|---|
| Improvement in Adipose Tissue Insulin Sensitivity. | -2.7 (-4.3 to -1.2) | -0.7 (-2.4 to 0.9) |
Relative percent changes from baseline in insulin-stimulated muscle glucose disposal (%) will be compared between both arms (i.e. \[24 week result- baseline result\]/baseline result \*100).
| percentage change from baseline | Lanifibranor Arm | Placebo |
|---|---|---|
| Improvement in Muscle Insulin Sensitivity (Rd). | 30 (13 to 46) | 0 (-17 to 18) |
Absolute changes from baseline will be compared between both arms (i.e., percentage at 24 weeks subtracted from the percentage at baseline).
| absolute percent change from baseline | Lanifibranor Arm | Placebo |
|---|---|---|
| Absolute Change in Glycemic Control (Hemoglobin A1c). | -0.7 (-1.0 to -0.5) | -0.1 (-0.3 to 0.2) |
Changes from baseline will be compared between both arms.
| absolute change in mg/dl from baseline | Lanifibranor Arm | Placebo |
|---|---|---|
| Change in Plasma HDL-C (mg/dl). | 7.6 (4.4 to 10.7) | 0.9 (-2.4 to 4.3) |
Changes from baseline in liver stiffness measurement in kPa by vibration controlled transient elastography measured in both arms.
| absolute change in kPa from baseline | Lanifibranor Arm | Placebo |
|---|---|---|
| Changes in Hepatic Fibrosis (Liver Stiffness Measurement by Vibration Controlled Transient Elastography in kPa) on Imaging. | -1.49 (-2.66 to -0.31) | -0.34 (-1.57 to 0.9) |
Absolute change (Mean ± SD) changes from baseline in plasma cytokeratin 18 (IU/L) levels in both arms.
| absolute change in from baseline in IU/L | Lanifibranor Arm | Placebo |
|---|---|---|
| Change in Plasma Biomarkers of Liver Fibrosis (Plasma Cytokeratin 18 Measured in IU/L). | -130.71 ± 164.28 | -70.21 ± 230.39 |
Changes from baseline in liver stiffness measurement by magnetic resonance elastography is measured in both arms (absolute change in kPa from baseline).
| kPa | Lanifibranor Arm | Placebo |
|---|---|---|
| Changes in Hepatic Fibrosis (Liver Stiffness Measurement by Magnetic Resonance Elastography in kPa) on Imaging. | 0.23 (0.03 to 0.42) | -0.06 (-0.25 to 0.13) |
Baseline liver stiffness measurement (LSM) by magnetic resonance elastography (in kPa) in both arms.
| kPa | Lanifibranor Arm | Placebo |
|---|---|---|
| Hepatic Fibrosis (Liver Stiffness Measurement by Magnetic Resonance Elastography) on Imaging. | 2.8 ± 0.8 | 2.5 ± 1.1 |
Collected over 28 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lanifibranor Arm | 0/20 (0%) | 1/20 (5%) | 18/20 (90%) |
| Placebo | 0/18 (0%) | 0/18 (0%) | 17/18 (94.4%) |
| Healthy Control Group (Not a Treatment Arm) | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Event | Lanifibranor Arm | Placebo | Healthy Control Group (Not a Treatment Arm) |
|---|---|---|---|
| COVID-19 pneumonia and pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/20 | 0/18 | 0/10 |
| Event | Lanifibranor Arm | Placebo | Healthy Control Group (Not a Treatment Arm) |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 5/19 | 3/18 | 0/10 |
| Elevated lipase levelGastrointestinal disorders | 5/20 | 3/18 | 1/10 |
| AnaemiaBlood and lymphatic system disorders | 4/20 | 2/18 | 0/10 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/20 | 3/18 | 0/10 |
| LeukopeniaBlood and lymphatic system disorders | 3/20 | 1/18 | 0/10 |
| HeadacheNervous system disorders | 3/20 | 1/18 | 0/10 |
| Decrease in eGFRRenal and urinary disorders | 1/20 | 2/18 | 0/10 |
| HyperglycemiaEndocrine disorders | 0/20 | 2/18 | 0/10 |
| Abnormal urinalysisRenal and urinary disorders | 0/20 | 2/18 | 0/10 |
| DermatologicalSkin and subcutaneous tissue disorders | 2/20 | 1/18 | 0/10 |
| Age, Continuous(years) | Lanifibranor Arm | Placebo | Healthy Control Group (Not a Treatment Arm) | Total |
|---|---|---|---|---|
| Mean | 61 ± 7 | 58 ± 11 | 43 ± 18 | 60 ± 8 |
| Sex: Female, Male(Participants) | Lanifibranor Arm | Placebo | Healthy Control Group (Not a Treatment Arm) | Total |
|---|---|---|---|---|
| Female | 11 | 13 | 6 | 30 |
| Male | 9 | 5 | 4 | 18 |
| Race (NIH/OMB)(Participants) | Lanifibranor Arm | Placebo | Healthy Control Group (Not a Treatment Arm) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 0 | 2 |
| White | 18 | 15 | 9 | 42 |
| More than one race | 1 | 1 | 0 | 2 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
| Region of Enrollment(participants) | Lanifibranor Arm | Placebo | Healthy Control Group (Not a Treatment Arm) | Total |
|---|---|---|---|---|
| United States | 20 | 18 | 10 | 48 |
| Intrahepatic triglyceride content(%) | Lanifibranor Arm | Placebo | Healthy Control Group (Not a Treatment Arm) | Total |
|---|---|---|---|---|
| Mean | 21 ± 7 | 18 ± 7 | 3 ± 1 | 19.5 ± 7.1 |
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Studies of the drug tested here: Lanifibranor
Non-alcoholic Fatty Liver Disease →