2023-506824-96-00已完成2 期
Efficacy and safety of NNC6019-0001 at two dose levels in participants with transthyretin amyloid cardiomyopathy (ATTR CM).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 14
- 主要终点
- Change in 6-minute walk test (6MWT) from baseline (week 0) to visit 15 (week 52)
研究概览
简要总结
To compare the effect of two dose levels of NNC6019-0001 (xx and xx) versus placebo on, change in 6-minute walk test and change in NT-proBNP from baseline to week 52 in participants with hereditary ATTR (hATTR) or wild-type ATTR (wtATTR) cardiomyopathy.
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
- •Male or female.
- •Age ≥ 18 to < 85 years at the time of signing informed consent.
- •Have an established diagnosis of ATTR CM with either wild-type TTR or hereditary TTR genotype as per local standards.
- •Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the randomisation visit.
- •Known end-diastolic interventricular septal wall thickness ≥ 12 mm.
- •Presently classified as New York Heart Association (NYHA) Class II-III.
- •NT-proBNP concentration ≥650 pg/mL in sinus cardiac rhythm and >1000 pg/mL in atrial fibrillation at screening.
- •Completed ≥150 meters to ≤450 meters on the 6MWT at screening.
- •Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 at screening.
排除标准
- •Cardiomyopathy not primarily caused by ATTR CM, for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease
- •A prior solid organ transplant.
- •Planned solid organ transplant during the study.
- •Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening.
- •Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response.
- •Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac valve repair, or major surgery within 3 months of screening.
- •Body weight >120 kg (264.6 lb) at screening.
- •History of contrast allergy or adverse reactions to gadolinium-containing agents.
结局指标
主要结局
Change in 6-minute walk test (6MWT) from baseline (week 0) to visit 15 (week 52)
Change in 6-minute walk test (6MWT) from baseline (week 0) to visit 15 (week 52)
Change in NT-proBNP from baseline (week 0) to visit 15 (week 52)
Change in NT-proBNP from baseline (week 0) to visit 15 (week 52)
次要结局
- Change in myocardial extracellular volume (ECV) from baseline (week 0) to visit 15 (week 52)
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) from baseline (week 0) to visit 15 (week 52)
- Change in neuropathy impairment score (NIS) (only hATTR patients) from baseline (week 0) to visit 15 (week 52)
- Change in troponin I from baseline (week 0) to visit 15 (week 52)
- Change in global longitudinal strain (GLS) on echocardiography from baseline (week 0) to visit 15 (week 52)
- Number of treatment emergent adverse events from baseline (week 0) to visit 16 (week 64)
- Time to occurrence of all-cause mortality from baseline (week 0) to visit 16 (week 64)
- Number of CV events comprising hospitalisation due to CV events or urgent heart failure visits (week 0) to visit 16 (week 64)
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (14)
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