A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of DR10624 Added to Standard Icosapent Ethyl Therapy in Adults With Severe Hypertriglyceridemia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 378
- 试验地点
- 2
- 主要终点
- Percentage change from baseline in average fasting serum triglyceride concentration at Week 26
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial for adults with severe hypertriglyceridemia whose lipid levels remain uncontrolled under standard Icosapent Ethyl background treatment plus lifestyle management. Eligible participants complete a screening run-in period, then randomize equally to three treatment groups: two active DR10624 subcutaneous injection groups and one placebo group. All subjects maintain fixed oral background lipid therapy throughout long-term double-blind treatment, followed by a short safety follow-up period. The primary objective is to evaluate the triglyceride-lowering effect of DR10624 versus placebo. Secondary assessments include other lipid indicators, liver fat content, overall safety, and anti-drug antibody status. Independent committees monitor interim data and adjudicate key clinical events to ensure participant safety.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, male or female; BMI 19.0-45.0 kg/m², body weight ≥50 kg at screening.
- •Fasting triglyceride (TG) range 5.65-22.60 mmol/L: single screening lab result meets range, plus average of two separate fasting TG tests (interval >1 week) within same range prior to randomization.
- •Stable lipid-lowering medications per local guidelines if on statin, cholesterol absorption inhibitor or PCSK9 inhibitor (minimum stable dose duration as required by drug class).
- •Females of childbearing potential agree effective contraception from ICF signing to 2 months post last dose; male participants agree contraception and no sperm donation for 3 months post last dose.
- •Able to understand study procedures, maintain consistent lifestyle and follow all protocol-specified requirements, and provide written informed consent.
排除标准
- •Confirmed hereditary lipid disorders (Fredrickson Type 1/3, Apo C-II deficiency).
- •Significant weight loss or planned weight reduction during study.
- •Severe chronic liver, renal or advanced cardiac disease.
- •Uncontrolled diabetes or hypertension with severe complications.
- •Pancreatitis history or symptomatic gallbladder disease.
- •Recent major cardiovascular, bone or thyroid disorders.
- •Severe psychiatric illness or substance abuse history.
- •Prior GLP-1/GCGR/FGF21 agonists or other investigational drugs within 3 months.
- •Abnormal screening lab parameters related to liver, pancreas, kidney or viral infection.
- •Pregnant, breastfeeding or hypersensitivity to study treatments.
- •Investigator's judgment of unsuitability for participation.
研究组 & 干预措施
Experimental Group 1: Weekly DR10624 Injection
干预措施: DR10624 Subcutaneous Injection (Drug)
Experimental Group 2: Weekly DR10624 Injection
干预措施: DR10624 Subcutaneous Injection (Drug)
Experimental Group 1: Weekly DR10624 Injection
干预措施: Icosapent Ethyl Oral Capsule (Drug)
Experimental Group 2: Weekly DR10624 Injection
干预措施: Icosapent Ethyl Oral Capsule (Drug)
Weekly Matching Placebo Injection
干预措施: Icosapent Ethyl Oral Capsule (Drug)
Weekly Matching Placebo Injection
干预措施: Matching Placebo Subcutaneous Injection (Drug)
结局指标
主要结局
Percentage change from baseline in average fasting serum triglyceride concentration at Week 26
时间窗: Baseline up to Week 26 of double-blind treatment period
Baseline TG defined as average value of Visit2, Visit3 and Visit4 fasting samples; Week26 TG defined as average of Week24 and Week26 fasting laboratory results; all participants receive continuous Icosapent ethyl 2g twice daily as background lipid-lowering treatment.
次要结局
- Percentage change from baseline in ApoC3 at Week 26(Baseline to Week 26 of double-blind treatment)
- Percent change from baseline LFC measured by MRI-PDFF Week26(Baseline and Week 26)
- Cumulative incidence of adjudicated acute pancreatitis up to Week 64(Randomization through Week 64 double-blind treatment period)
- Proportion of participants with treatment-emergent adverse events (TEAEs) throughout the study(First study drug injection through 4-week post-treatment safety follow-up)
- Percentage change from baseline in TRL-C at Week 26(Baseline to Week 26 of double-blind treatment)