NL-OMON53417招募中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 Nonalcoholic steatohepatitis (NASH) and type 2 Diabetes mellitus (T2DM) - LEGEND study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Able to understand the nature of the study, willing and able to comply with
- •the study procedures and restrictions, and willing to provide informed consent
- •obtained before any study-related activities
- •2. The patient is willing to continue on the study in case of moving or
- •relocating to a different region/city where there would be no active study site
- •3. Able to communicate meaningfully with the Investigator and legally competent
- •to provide written informed consent
- •4. Male or female, aged >= 18 years at the time of signing informed consent
- •5. Diagnosis of NASH
- •a. based on a historical (within 12 months prior to Screening) liver biopsy
- •with a non alcoholic fatty liver disease activity score (NAS) >= 4 with a score
- •of one or more in each sub-component (steatosis, hepatocyte ballooning, lobular
- •inflammation) and no documented cirrhosis in the last 12 months prior to
- •Screening OR
- •b. NASH screening:
- •i. High Risk NASH defined as cT1 >=> 875 ms assessed by LiverMultiScan® OR
- •ii. NASH defined as cT1 >= 825 ms assessed by LiverMultiScan® and hepatic fat
- •content >= 10% assessed by MRI-PDFF
- •6. HbA1c at screening >= 7.0 and <= 10.0%, on diet alone, or on metformin (>=
- •1,000 mg/day), and/or dipeptidyl peptidase 4 inhibitor (DPP-IVi) therapy. Doses
- •have no qualitative change for 3 months prior to informed consent. These
- •medicines will be continued at stable doses during the entire study.
- •7. Negative pregnancy test at Screening for females of childbearing potential
- •or at least two-year post-menopausal. Women of childbearing potential (i.e.,
- •fertile, following menarche and until becoming post-menopausal unless
- •permanently sterile) have to use a highly effective method of contraception
- •throughout the study and for one month after treatment discontinuation. Highly
- •effective contraceptive methods are defined as follows: combined (estrogen and
- •progestogen containing) hormonal contraception associated with inhibition of
- •ovulation (oral, intravaginal, transdermal), progestogen-only hormonal
- •contraception associated with inhibition of ovulation (oral, injectable,
- •implantable), intrauterine device (IUD), intrauterine hormone-releasing system
- •(IUS), bilateral tubal occlusion, vasectomized partner (provided he is her sole
- •sexual partner and he has received medical assessment of the surgical success),
- •and true sexual abstinence (when this is in line with the preferred and usual
- •lifestyle of the patient) whereas periodic abstinence (e.g., calendar,
- •ovulation, symptothermal, post-ovulation methods) and withdrawal are not
- •acceptable methods of contraception.
排除标准
- •Liver-related:
- •1. Documented causes of chronic liver disease other than NASH (see protocol for
- •details, see exclusion criteria no 50 for autoimmune diseases)
- •a. Viral hepatitis, documented with
- •i. Positive hepatitis B surface antigen (HBsAg)
- •ii. Positive hepatitis C virus ribonucleic acid (RNA) (tested for in case of
- •known cured hepatitis C virus [HCV] infection or positive HCV serology at
- •Screening). Patients with a history of HCV infection can be included if HCV PCR
- •is negative since more than 3 years.
- •b. Drug-induced liver disease
- •c. Autoimmune hepatitis
- •d. Wilson*s disease
- •e. Hemochromatosis
- •f. Primary biliary cholangitis
- •g. Primary sclerosing cholangitis
- •h. *1-antitrypsin deficiency
- •2. Histologically documented liver cirrhosis (fibrosis stage F4), based on a
- •historical biopsy (within 12 months prior to Screening); or diagnosis of
- •cirrhosis at Screening based on clinic biochemical and imaging criteria
- •(FibroScan® value confirmed >= 14 kPa and FIB-4 > 3.25 provided to the site by
- •the central lab)
- •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) at Screening
- •7. Abnormal liver function as defined by central laboratory evaluation of any
- •of the following:
- •a. Albumin < lower limit of normal range (LLN)
- •b. International normalized ratio (INR) >= 1.3 (unless patient is on
- •anticoagulants)
- •c. 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 (7.7µmol/L))
- •8. Hemoglobin < 110 g/L (11 g/dL) for females and < 120 g/L (12 g/dL) for males
- •9. White blood cell count (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. Alkaline phosphatase (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,
- •which is typically defined as higher than 30 g pure alcohol per day for men and
- •as higher than 20 g pure alcohol per day for women (please also refer to
- •Section 13.1). No binge drinking during the last year. Consuming 75 g pure
- •alcohol (male), or 60 g pure alcohol (female), or more in about 2 hours
- •14. Administration of drugs known to produce hepatic steatosis in the 6 months
- •prior to Screening (such as high-dose estrogens, methotrexate, tetracycline, or
- •amiodarone) (see also Section 13.2)
- •Diabetes related:
- •15. Diabetes mellitus other than type 2 (e.g., type 1, endocrinopathy, and
- 另有 9 项未显示
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