EUCTR2019-000440-10-DE进行中（未招募）1 期
ASH EXploratory Single and COmbination Treatment (NEXSCOT): An open label, multicenter, platform study to evaluate the safety, tolerability, pharmacokinetics and efficacy of various single and combination treatments in patients with non-alcoholic fatty liver disease (NAFLD) who manifest a non-alcoholic steatohepatitis (NASH)-like biomarker phenotype - NEXSCOT
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Phenotypic diagnosis of NASH based on the presence of all of the
- •ALT = 43 IU/L (males) or = 28 IU/L (females) at screening
- •BMI = 27 kg/m2 (in participants with a self-identified race other than
- •Asian) or = 23 kg/m2 (in participants with a self-identified Asian race)
- •History of Type 2 diabetes mellitus with HbA1c = 9% at baseline
- •ELF Test score = 8.5 and = 10.5 at either screening or baseline
- •Liver fat = 8%
- •Participants must weigh at least 40 kg (88 lbs.) and no more than 150
- •kg (330 lbs.)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Use of other investigational drugs within 5 half-lives of randomization, or within 3 months, whichever is longer
- •Use of obeticholic acid (OCA) or pharmacologically-active weight loss drugs within 1 month of randomization.
- •Use of strong CYP3A4/5 inhibitors or strong CYP3A4 inducers within 5 half-lives or 7 days of randomization, whichever is longer.
- •History or presence of other concomitant liver diseases
- •History or current diagnosis of ECG abnormalities
- •Patients with contraindications to MRI imaging
- •Current or history of significant alcohol consumption
- •Clinical evidence of hepatic decompensation or severe liver impairment
- •Women of child bearing potential (unless on highly effective methods of contraception)
- •Presence of liver cirrhosis
- •For cohort 1, use of OAT3 inhibitors or BRCP inhibitors within 5 half-lives or 7 days of randomization, whichever is longer
研究者
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