2026-525182-53-00招募中3 期
Zenagamtide use for the reduction of risk of major adverse cardiovascular events in people with established atherosclerotic cardiovascular disease and either overweight or obesity (AMBIENCE)
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
- 320
- 试验地点
- 145
- 主要终点
- Time from randomisation to first occurrence of a 4-P composite MACE endpoint consisting of: - CV death - Non-fatal MI - Non-fatal stroke - HF hospitalisationa or urgent HF visit
研究概览
简要总结
To demonstrate superiority of zenagamtide once weekly versus placebo, both added to SoC on time to first MACE in participants with established ASCVD and either overweight or obesity.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Established ASCVD is defined as at least one of the below conditions (a-c): a. Prior myocardial infarction (MI) b. Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an ankle-brachial index (ABI) < 0.85 at rest ii. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis) c. Cerebrovascular disease defined as the following: i. Prior stroke
- •Participants with T2D (at screening) are allowed in the study with the following provisions: a. Treatment should be stable for ≥ 90 days before screening as assessed by the investigator. b. Glucose lowering agents are permitted according to local label except GLP-1 RA, GIP and amylin analogues; for insulins, only basal insulin is allowed.
排除标准
- •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.
- •Coronary, carotid, or peripheral artery revascularization or percutaneous valve repair or replacement within 30 days prior to the day of screening or planned during the study period and known at screening (CCI).
- •Chronic heart failure classified as (CCI) at screening. Glycaemia-related
- •Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
- •Known history of hypoglycaemia unawareness as indicated by the investigator according to Clarke’s questionnaire 1 question
- •History of type 1 diabetes (T1D).
- •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
- •Glycated haemoglobin (HbA1c) > 10% (86 mmol/mol) as measured by central laboratory at screening.
- •Treatment with any GLP-1 RA, GIP RA or amylin analogue for any indication within (CCI) before screening.
研究组 & 干预措施
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)
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)
Placebo (Zenagamtide)
Placebo
干预措施: Placebo (Zenagamtide) (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)
结局指标
主要结局
Time from randomisation to first occurrence of a 4-P composite MACE endpoint consisting of: - CV death - Non-fatal MI - Non-fatal stroke - HF hospitalisationa or urgent HF visit
Time from randomisation to first occurrence of a 4-P composite MACE endpoint consisting of: - CV death - Non-fatal MI - Non-fatal stroke - HF hospitalisationa or urgent HF visit
次要结局
- Time from randomisation to first occurrence of an expanded composite 5-P MACE endpoint consisting of: - All-cause death - Non-fatal MI - Non-fatal stroke - HF hospitalisationa or urgent HF visit - Coronary revascularization
- Time from randomisation to first occurrence of a composite 3-P MACE endpoint consisting of: - CV death - Non-fatal MI - Non-fatal stroke
- Change in eGFR (creatinine and cystatin C-based CKD-EPI 2021) for participants with baseline eGFR<60 mL/min/1.73 m2
- Time from randomisation to all-cause death
- Time from randomisation to CV death
- CCI
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (145)
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