2023-503576-25-00进行中（未招募）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)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 89bio Inc.
- 入组人数
- 169
- 试验地点
- 53
- 主要终点
- Percent change from baseline in fasting TG at Week 26
研究概览
简要总结
To determine the effect of pegozafermin on fasting serum triglyceride levels in subjects with Severe Hypertriglyceridemia after 26 weeks of treatment
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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)
结局指标
主要结局
Percent change from baseline in fasting TG at Week 26
Percent change from baseline in fasting TG at Week 26
次要结局
- 1. Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 26
- 2. Percent change from baseline in high-density lipoprotein cholesterol (HDL-C) at Week 26
- 3. Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C) at Week 26
- 4. Percent change from baseline in total cholesterol (TC) at Week 26
- 5. Percent change from baseline in fasting TG at Week 52
- 6. Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF) at Week 26
- 7. Percent change from baseline in apolipoprotein B (apo-B) at Week 26
- 8. Change in HbA1c at Week 26 for those with baseline ≥7.0%
研究者
ENTRUST scientific
Scientific
89bio Inc.
研究点 (53)
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