A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING, PARALLEL GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-05221304 ADMINISTERED DAILY FOR 16-WEEKS TO ADULT SUBJECTS 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
- 305
- 试验地点
- 137
- 主要终点
- Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16
研究概览
简要总结
Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
详细描述
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety, Tolerability, And Pharmacodynamics Of PF-05221304 Administered Daily For 16-weeks To Adult Subjects 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
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index >= 25 kg/m2
- •Body Weight > 50 kg
- •Liver fat (assessed via MRI-PDFF) >= 8%
- •Biopsy-proven NASH - diagnosed in previous 24-months
- •Presumed NASH - per Sponsor's definition
- •NAFLD with minimal inflammation/fibrosis
- •Features of Metabolic Syndrome
排除标准
- •Alcohol-induced steatohepatitis or other forms of chronic liver disease
- •Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus
- •Severe Renal Impairment
- •Contraindications for MRI
研究组 & 干预措施
Placebo
Double-Blind, PF-05221304-matching Placebo
干预措施: Placebo (Drug)
PF-05221304 - 2 mg
PF-05221304 - 2 mg, once-daily
干预措施: PF-05221304 (Drug)
PF-05221304 - 10 mg
PF-05221304 - 10 mg, once-daily
干预措施: PF-05221304 (Drug)
PF-05221304 - 25 mg
PF-05221304 - 25 mg, once-daily
干预措施: PF-05221304 (Drug)
PF-05221304 - 50 mg
PF-05221304 - 50 mg, once-daily
干预措施: PF-05221304 (Drug)
结局指标
主要结局
Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16
时间窗: Baseline (between Day -14 and Day 1), Week 16
MRI-PDFF utilized a gradient echo sequence with low flip angle (FA) to minimize T1 bias, corrected T2\* decay (due to iron overload) via modeling of the fat signal as a superposition of multiple frequency components from 5 different lipid types, and was applied in each of the 9 Couinaud segments. This technique improved fat quantification accuracy for the entire liver permitting quantification of small differences/changes following pharmacological intervention.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events(From first dose of study treatment (Day 1) up to Week 20)
- Percent Change From Baseline in Alanine Aminotransferase at Week 16(Baseline (Day 1 pre-dose), Week 16)
- Number of Participants With Laboratory Abnormalities(From first dose of study treatment (Day 1) up to Week 20)
- Number of Participants With Vital Signs Data Meeting Predefined Criteria(From first dose of study treatment (Day 1) up to Week 18)
- Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria(From first dose of study treatment (Day 1) up to Week 18)