临床试验/NCT05232071

NCT05232071已完成2 期

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)

Inventiva Pharma83 个研究点分布在 5 个国家目标入组 39 人开始时间: 2022年6月29日最近更新: 2026年9月9日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Inventiva Pharma
入组人数: 39
试验地点: 83
主要终点: Assessment of the 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

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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
•Cardiovascular related:
•21. History of or current unstable cardiac dysrhythmias
•Unstable heart failure
•Uncontrolled hypertension
•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
•Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value < 60 mL/min
•Concomitant treatment with PPAR-⍺ agonists (fibrates)
•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
•Have a known hypersensitivity to any of the IMPs
•Previous exposure to lanifibranor or empagliflozin
•Present pregnancy/lactation
•Metallic implant of any sort that prevents MRI examination
•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.

研究组 & 干预措施

Matching placebo

Placebo Comparator

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

干预措施: Placebo (Drug)

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

Experimental

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

干预措施: Empagliflozin (Drug)

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

Experimental

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

干预措施: Lanifibranor (Drug)

Lanifibranor (800 mg/day)

Experimental

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.

干预措施: Lanifibranor (Drug)

结局指标

主要结局

Assessment of the 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

时间窗: Date of randomisation until the end of treatment at week 24

Absolute change in HbA1c from baseline (Week 0) to Week 24

Absolute Change in HbA1c

时间窗: From Baseline to Week 24

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

次要结局

Change in Insulin Resistance and Glycaemic Control (Adiponectin)(from Baseline to Week 24)
Change in Liver Tests (ALT)(from Baseline to Week 24)
Change in Liver Tests (AST)(from Baseline to Week 24)
Percentage Change in Insulin Resistance and Glycaemic Control (HOMA-IR)(from Baseline to Week 24)
Change in Insulin Resistance and Glycaemic Control (Insulin)(from Baseline to Week 24)
Change in Lipid Parameters (HDL Cholesterol)(from Baseline to Week 24)
Change in Body Weight and Body Composition (Body Weight)(from Baseline to Week 24)
Change in Body Weight and Body Composition (VAT/SAT Ratio)(from Baseline to Week 24)

研究者

发起方

Inventiva Pharma

申办方类型

Industry

责任方

Sponsor

研究点 (83)

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