NCT05852431已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia (SHTG): The ENTRUST Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 89bio, Inc.
- 入组人数
- 369
- 试验地点
- 184
- 主要终点
- Percent change from baseline in fasting TG
研究概览
简要总结
To determine the effect of Pegozafermin on fasting serum triglyceride levels in subjects with Severe Hypertriglyceridemia (TG ≥500 to ≤2000 mg/dL) after 26 weeks of treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥22 years
- •Willing to enter a medication/lifestyle stabilization period during the screening period, which means maintaining those stable medication, eating, and exercise habits for the duration of the study
- •Subjects should be on stable background Lipid Modifying Therapy (LMT) to manage ASCVD for a minimum of 4 weeks prior to first qualifying TG
排除标准
- •Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- •Uncontrolled or newly diagnosed (≤3 months since diagnosis) Type 2 diabetes mellitus as determined by the Principal Investigator. Subjects must have HbA1c level ≤9.5% at Screening. Medications for glucose management must be stable for at least 4 weeks prior to Screening
- •Type 1 diabetes mellitus
- •A history of symptomatic gallstone disease, gallstone pancreatitis (unless treated with cholecystectomy), or any other ongoing symptomatic biliary disease
- •Acute pancreatitis within 6 months prior to Screening
- •Subjects with chronic pancreatitis
- •Known or suspected familial chylomicronemia syndrome (FCS) (Type 1 hyperlipoproteinemia)
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Pegozafermin - 30mg once a week
Experimental
干预措施: Pegozafermin (Drug)
Placebo once a week
Placebo Comparator
干预措施: Placebo (Drug)
Pegozafermin - 20mg once a week
Experimental
干预措施: Pegozafermin (Drug)
结局指标
主要结局
Percent change from baseline in fasting TG
时间窗: 26 weeks
次要结局
- Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C)(26 weeks)
- Percent change from baseline in high-density lipoprotein cholesterol (HDL-C)(26 weeks)
- Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C)(26 weeks)
- Percent change from baseline in total cholesterol (TC)(26 weeks)
- Percent change from baseline in apolipoprotein B (apo-B)(26 weeks)
- Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF)(26 weeks)
- Change in HbA1c at Week 26 for those with baseline ≥7.0%(26 weeks)
- Percent change from baseline in fasting TG(52 weeks)
研究者
研究点 (184)
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