NCT07271186招募中2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of ALN-ANG3 in Participants With Diabetic Kidney Disease
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 195
- 试验地点
- 58
- 主要终点
- Percent Change in Urine Albumin to Creatinine Ratio (UACR)
研究概览
简要总结
This study is researching an experimental drug called ALN-ANG3 (called "study drug"). The study is focused on participants who have diabetic kidney disease.
The aim of the study is to see how safe and effective the study drugs are.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical history of type 2 diabetes and receiving medical therapy or lifestyle interventions for glucose management
- •Hemoglobin A1C (HbA1c) of 6.5 to 10% at screening
- •eGFR 30 to 90 mL/min/1.73 m^2 using 2021 Chronic Kidney Disease-Epidemiology Collaboration-Estimated Glomerular Filtration Rate using Creatinine and Cystatin C (CKD-EPI eGFRcr-cys) equation at screening
- •Albuminuria: Urine Albumin to Creatinine Ratio (UACR) of 500 to 5000 mg/g at screening
排除标准
- •Known medical history or clinical evidence indicative of non-diabetic renal disease
- •Renal disease that required treatment with systemic immunosuppressive therapy (prior or current), or a history of end-stage kidney disease requiring treatment with chronic dialysis or kidney transplantation
- •Medically unstable as assessed by the investigator or hospitalization (ie, >24 hours) within 30 days of the screening visit
- •NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
ALN-ANG3
Experimental
干预措施: ALN-ANG3 (Drug)
ALN-ANG3 + evinacumab
Experimental
This arm has been closed
干预措施: ALN-ANG3 (Drug)
ALN-ANG3 + evinacumab
Experimental
This arm has been closed
干预措施: Evinacumab (Drug)
结局指标
主要结局
Percent Change in Urine Albumin to Creatinine Ratio (UACR)
时间窗: Baseline to Week 24
Percent change in Urine Albumin to Creatinine Ratio (UACR)
时间窗: Baseline to Week 24
次要结局
- Change in Total Cholesterol(Baseline to Week 24)
- Change in Non-High-Density Lipoprotein-Cholesterol (non-HDL-C)(Baseline to Week 24)
- Change in Triglycerides(Baseline to Week 24)
- Concentration of Combined ALN-ANG3 and Metabolite(s)(Up to Week 24)
- Change in Concentration of Angiopoietin-Like Protein-3 (ANGPTL-3)(Baseline to Week 24)
- Occurence of Anti-Drug Antibodies (ADAs) to ALN-ANG3(Through Week 24)
- Change in Estimated Glomerular Filtration Rate (eGFR)(Baseline to Week 24)
- Change in total cholesterol(Baseline to Week 24)
- Change in Low-Density Lipoprotein-Cholesterol (LDL-C)(Baseline to Week 24)
- Change in High-Density Lipoprotein-Cholesterol (HDL-C)(Baseline to Week 24)
- Change in non-High-Density Lipoprotein-Cholesterol (non-HDL-C)(Baseline to Week 24)
- Change in triglycerides(Baseline to Week 24)
- Change in Apolipoprotein B (ApoB)(Baseline to Week 24)
- Concentration of combined ALN-ANG3 and metabolite(s) and evinacumab(Up to Week 24)
- Change in concentration of Angiopoietin-Like Protein-3 (ANGPTL-3)(Baseline to Week 24)
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)(Up to Week 48)
- Severity of TEAEs(Up to Week 48)
- Incidence of ADAs to ALN-ANG3(Through Week 24)
- Magnitude of ADAs to ALN-ANG3(Through Week 24)
- Incidence of ADAs to evinacumab(Through Week 24)
- Magnitude of ADAs to evinacumab(Through Week 24)
研究者
研究点 (58)
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