NCT04006145已完成2 期
A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Explore the Efficacy and Safety of Elobixibat in Adults With Nonalcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Albireo
- 入组人数
- 47
- 试验地点
- 10
- 主要终点
- Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16
研究概览
简要总结
Double-blind, randomized, placebo-controlled study to explore the efficacy and safety of elobixibat compared to placebo in adults with NAFLD (nonalcoholic fatty liver disease) or NASH (nonalcoholic steatohepatitis)
详细描述
A total of 15 investigators at 15 sites received institutional review board (IRB)/ethics committee (EC) approval to participate in this study and enrolled at least 1 participant.
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
- Triple (Participant, 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
- •Have a current biopsy-confirmed NASH within 6 months of screening or a suspected diagnosis of NAFLD/NASH
- •Screening magnetic resonance imaging-proton density fat fraction (MRI-PDFF) with ≥10% liver steatosis
- •Fasting serum low density lipoprotein-cholesterol (LDL-C) >130 mg/dL at Screening, >110 mg/dL on lipid-lowering medications
排除标准
- •Body mass index (BMI) <25 kg/m2
- •Fibrosis-4 index (Fib-4) >2.6
- •Any of the following laboratory abnormalities:
- •alanine aminotransferase (ALT) >5 × upper limit of normal (ULN) or aspartate aminotransferase (AST) >5 × ULN
- •International normalized ratio (INR) ≥1.3, unless on anticoagulant therapy
- •Total bilirubin >ULN, except with an established diagnosis of Gilbert's syndrome
- •Platelet count less than the lower limit of normal (LLN)
- •Creatinine clearance as calculated by the modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) equation <60 mL/min
- •Uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) >9.5%
- •Clinical hyperthyroidism or hypothyroidism or screening hormone results pointing to thyroid dysfunction.
- •Uncontrolled hypertension
- •Participants with known intolerance to MRI or with conditions contraindicated for MRI procedures
研究组 & 干预措施
Elobixibat
Experimental
Elobixibat 5 mg once daily
干预措施: Elobixibat (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16
时间窗: Week 16
The primary efficacy endpoint was the change from Baseline in serum LDL-C at Week 16. Baseline was defined as the last non-missing LDL-C value prior to the first dose of study drug.
次要结局
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(From first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months)
- Absolute Change From Baseline to Week 16 in Liver Fat Fraction(Baseline (Day 1) and Week 16)
- Absolute Change From Baseline to Week 16 in Total Liver Fat(Baseline (Day 1) and Week 16)
- Change From Baseline to Week 16 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl Transferase (GGT)(Baseline (Day 1) and Week 16)
- Change From Baseline to Week 16 in High-density Lipoprotein (HDL) Cholesterol, Non-high-density Lipoprotein Cholesterol and Triglycerides(Baseline (Day 1) and Week 16)
- Change From Baseline to Week 16 in Low-density Lipoprotein (LDL) Cholesterol to High-density Lipoprotein Cholesterol Ratio(Baseline (Day 1) and Week 16)
- Change From Baseline to Week 16 in Total Bile Acids(Baseline (Day 1) and Week 16)
研究者
研究点 (10)
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