A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PARALLEL- GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 53
- 试验地点
- 8
- 主要终点
- Percent Change From Baseline in Whole Liver Fat at Week 6
研究概览
简要总结
IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI at least 28 kg/m2
- •Type 2 diabetes and/or metabolic syndrome
排除标准
- •Liver disease
- •Type 1 diabetes
- •Recent heart attack or stroke
- •Inability to have an MRI scan
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
PF-06835919 Low Dose
75 mg once daily
干预措施: PF-06835919 Low Dose (Drug)
PF-06835919 High Dose
300 mg once daily
干预措施: PF-06835919 High Dose (Drug)
结局指标
主要结局
Percent Change From Baseline in Whole Liver Fat at Week 6
时间窗: Baseline and Week 6
The percent change from baseline in whole liver fat at Week 6 was assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF). MRI-PDFF generates measures of the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF was calculated as follows: Whole Liver PDFF= PDFFs for (Segment I+Segment II+Segment III+Segment IVa+Segment IVb+Segment V+Segment VI+Segment+VII+Segment VIII) / (number of segments assessed). The same segments were to be used at both baseline and post-baseline time points in the calculation of whole liver PDFF to derive the percent change from baseline. The values of whole liver PDFF ranges from 0 to 100 and higher values represent higher liver fat.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Baseline up to Day 77 (28-35 days post last dose))
- Number of Participants With Post-dose Vital Signs Data Meeting Categorical Criteria(Baseline up to Day 56 (Week 8))
- Number of Participants With Post-dose ECG Data Meeting Categorical Criteria(Baseline up to Day 56 (Week 8))
- Number of Participants With Laboratory Abnormalities(Baseline up to Day 56 (Week 8))