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

Completed · Phase 2 · Has a placebo group

Conditions studied: NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT05232071

Run by

Inventiva Pharma

People needed

42

Starts

2022-06-29

Expected to finish

2024-06-04

Last updated by the study team

2024-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, aged ≥ 18 years at the time of signing informed consent
• 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
• 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
• Negative pregnancy test at Screening for females of childbearing potential or at least two-year post-menopausal.

You may not qualify if…

• Liver-related:
• Documented causes of chronic liver disease other than NASH
• Histologically documented liver cirrhosis (fibrosis stage F4)
• History or current diagnosis of hepatocellular carcinoma (HCC)
• History of or planned liver transplant
• Documented history of human immunodeficiency virus (HIV) infection
• ALT or AST > 5 × upper limit of normal (ULN)
• 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) )
• Hemoglobin < 110 g/L (11 g/dL) for females and < 120 g/L (12 g/dL) for males
• WBC < LLN. A lower count is acceptable in patients with benign ethnic neutropenia, if considered to be clinical insignificant by the investigator
• Platelet count < 140,000/µL
• ALP > 2 × ULN
• Patient currently receiving any approved treatment for NASH or obesity
• Current or recent history (< 5 years) of significant alcohol consumption
• Administration of drugs known to produce hepatic steatosis in the 6 months prior to Screening.
• Diabetes related:
• Diabetes mellitus other than type 2
• Diabetic ketoacidosis at Screening
• Current treatment with glucagon-like peptide-1 receptor agonists (GLP-1RA), insulin or sulfonylurea or treatment within the last 3 months prior to Screening
• Patients on pioglitazone in the last 12 months prior to Screening.
• 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:
• BMI>45 kg/m2 at screening
• 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.

Where it is running

• Central Virginia VA Healthcare System — Richmond, Virginia, United States
• Birmingham Digestive Health Research — Homewood, Alabama, United States
• Institute for Liver Health dba Arizona Liver Health — Chandler, Arizona, United States
• ARcare Center for Clinical Research — Conway, Arkansas, United States
• ARcare Center for Clinical Research — Little Rock, Arkansas, United States
• Cure Clinical Research, LLC — Fountain Valley, California, United States
• Velocity Clinical Research — Gardena, California, United States
• National Research Institute — Huntington Park, California, United States
• Cadena Care Institute, LLC — Poway, California, United States
• Florida Research Institute — Lakewood Rch, Florida, United States
• Galenus Group — Lehigh Acres, Florida, United States
• Prolive Medical Research — Miami, Florida, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Digestive Health Research of Southern California — South Bend, Indiana, United States
• Tandem Clinical Research - New Orleans Area Site — Marrero, Louisiana, United States
• Harvard Medical School — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• AIG Digestive Disease Research — Florham Park, New Jersey, United States
• Digestive Health Research — Hermitage, Tennessee, United States
• Accelemed Research Institute — Austin, Texas, United States
• Dallas Diabetes Research Center — Dallas, Texas, United States
• American Research Corporation — San Antonio, Texas, United States
• Diabetes & Glandular Disease Clinic, P.A. — San Antonio, Texas, United States
• Impact Research Institute — Waco, Texas, United States
• Digestive Health Research of North Texas — Wichita Falls, Texas, United States

Full record on ClinicalTrials.gov

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