CTIS2023-503576-25-00招募中1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Severe Hypertriglyceridemia (SHTG) - BIO89-100-231
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 89bio Inc.
- 入组人数
- 416
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Age =22 years, 2. 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, 3. 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
- •1. Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV), 2. 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, 3. Type 1 diabetes mellitus, 4. A history of symptomatic gallstone disease, gallstone pancreatitis (unless treated with cholecystectomy), or any other ongoing symptomatic biliary disease, 5. Acute pancreatitis within 6 months prior to Screening, 6. Subjects with chronic pancreatitis, 7. Known or suspected familial chylomicronemia syndrome (FCS) (Type 1 hyperlipoproteinemia)
研究者
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