2025-523717-29-00招募中3 期
Efficacy and safety of NNC0487-0111 compared to placebo on morbidity and mortality in people with heart failure with preserved or mildly reduced ejection fraction and obesity (HF-POLARIS).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,992
- 试验地点
- 271
- 主要终点
- Time to first occurrence of a composite HF endpoint consisting of: CV death, HF hospitalisation or urgent HF visit
研究概览
简要总结
To demonstrate that NNC0487-0111 once weekly versus placebo, both added to SoC, reduces the risk of a composite outcome including CV death, HF hospitalisation or urgent HF visit in participants with HFpEF or HFmrEF, and obesity.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) ≥30 kg/m2 at screening.
- •Diagnosis of HF with New York Heart Association (NYHA) class II-IV and in stable condition at screening, at the discretion of the investigator.
- •For participants with T2D at screening:
- •Diagnosed with T2D ≥ 30 days before screening.
排除标准
- •Myocardial infarction (MI), stroke, unstable angina pectoris or worsening HF leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization
- •Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- •Treatment with multiple daily insulin injections or continuous subcutaneous insulin infusion.
- •HbA1c >10% (86 mmol/mol) as measured by local or central laboratory at screening.
- •Coronary, carotid, or peripheral artery revascularization planned during the study period and known at screening (visit 1).
- •HF due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, Chagas cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, or uncorrected primary valve disease of moderate or severe degree.
- •Severe pulmonary disease including primary pulmonary hypertension, chronic pulmonary embolism, or severe chronic obstructive pulmonary disease (COPD) defined as: - requiring home oxygen; or - ongoing oral corticosteroid therapy; or - hospital for COPD exacerbation within 12 months prior to screening.
- •Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism).
- •History of type 1 diabetes.
研究组 & 干预措施
Placebo (NNC0487-0111)
Placebo
干预措施: Placebo (NNC0487-0111) (Drug)
NNC0487-0111 B 10142, NNC0487-0111 B 10144, NNC0487-0111 B 10146, NNC0487-0111 B 10141, NNC0487-0111 B 10143, NNC0487-0111 B 10145
Test
干预措施: NNC0487-0111 B 10145 (Drug)
NNC0487-0111 B 10142, NNC0487-0111 B 10144, NNC0487-0111 B 10146, NNC0487-0111 B 10141, NNC0487-0111 B 10143, NNC0487-0111 B 10145
Test
干预措施: NNC0487-0111 B 10142 (Drug)
NNC0487-0111 B 10142, NNC0487-0111 B 10144, NNC0487-0111 B 10146, NNC0487-0111 B 10141, NNC0487-0111 B 10143, NNC0487-0111 B 10145
Test
干预措施: NNC0487-0111 B 10144 (Drug)
NNC0487-0111 B 10142, NNC0487-0111 B 10144, NNC0487-0111 B 10146, NNC0487-0111 B 10141, NNC0487-0111 B 10143, NNC0487-0111 B 10145
Test
干预措施: NNC0487-0111 B 10146 (Drug)
NNC0487-0111 B 10142, NNC0487-0111 B 10144, NNC0487-0111 B 10146, NNC0487-0111 B 10141, NNC0487-0111 B 10143, NNC0487-0111 B 10145
Test
干预措施: NNC0487-0111 B 10141 (Drug)
NNC0487-0111 B 10142, NNC0487-0111 B 10144, NNC0487-0111 B 10146, NNC0487-0111 B 10141, NNC0487-0111 B 10143, NNC0487-0111 B 10145
Test
干预措施: NNC0487-0111 B 10143 (Drug)
结局指标
主要结局
Time to first occurrence of a composite HF endpoint consisting of: CV death, HF hospitalisation or urgent HF visit
Time to first occurrence of a composite HF endpoint consisting of: CV death, HF hospitalisation or urgent HF visit
次要结局
- CCI
- Change in KCCQ-CSS for participants with baseline KCCQ‑CSS score <80 points
- Change in eGFR (creatinine and cystatin C‑based CKD‑EPI 2021) for participants with baseline eGFR<60 mL/min/1.73 m2
- Time to first occurrence of a composite HF and MACE endpoint consisting of: CV death, HF hospitalisation or urgent HF visit, Nonfatal MI, Nonfatal stroke
- Time to all-cause death
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (271)
Loading locations...
相似试验
尚未招募
3 期
AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and Type 2 Diabetes Lose WeightDiabetes Mellitus, Type 2ObesityNCT07400107Novo Nordisk A/S1,000
招募中
3 期
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose WeightOverweightObesityDiabetes MellitusNCT07533175Novo Nordisk A/S630
招募中
3 期
AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose WeightNCT07339423Novo Nordisk A/S1,150
进行中（未招募）
3 期
AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight LossObesityNCT07503210Novo Nordisk A/S606
招募中
3 期
AMAZE 6: A research study investigating how well the medicine NNC0487-0111 helps people with excess body weight and knee osteoarthritis lose weight and reduce painOverweight or obesity, and knee osteoarthritis2024-520445-23-00Novo Nordisk A/S220