2024-516654-22-00招募中3 期
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)
Amgen Inc.272 个研究点 分布在 3 个国家目标入组 2,787 人开始时间: 2025年9月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,787
- 试验地点
- 272
- 主要终点
- Time to first occurrence of a composite endpoint consisting of: o CV death, or o hospitalization for HF, or o urgent HF visits
研究概览
简要总结
To demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care on the composite endpoint of heart failure (HF) events (hospitalization for HF or urgent HF visits) or death from cardiovascular (CV) disease in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) and a body mass index (BMI) ≥ 30 kg/m2
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Open-label Extension (Part 2)
- 盲法
- None
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
- 否
入选标准
- •Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years)
- •BMI ≥ 30 kg/m2 at screening
- •HF diagnosed for at least 30 days before screening with NYHA Class II-IV at screening
- •Managed with HF standard of care therapies consistent with regional clinical practice guidelines stable for at least 14 days according to investigator judgment
- •Documented LVEF of > 40% measured by any modality within the last 12 months, at the latest at screening.
- •Elevated NT-proBNP > 300 pg/mL for patients in sinus rhythm, or > 600 pg/mL for participants in active atrial fibrillation (AF) or atrial flutter (AFL), at screening
- •Participants must have at least one of the following: 1) Structural heart disease criteria documenting at least 1 of the following on echocardiogram within 12 months before randomization: a. Average E/é ≥ 15 b. Left atrial (LA) enlargement (LA width ≥ 3.8 cm, or LA length ≥ 5.0 cm, or LA area ≥ 20.0 cm2, or LA volume ≥ 55 mL, or LA volume index ≥ 34 mL/m2) c. Left ventricular (LV) hypertrophy with septal thickness, or posterior wall thickness ≥ 1.2 cm OR 2) Documented hospitalization with a primary diagnosis of decompensated HF which required IV loop diuretic treatment, within 12 months before randomization. OR 3) Evidence of elevated filling pressures within 12 months before randomization: Mean pulmonary wedge pressure ≥ 15 mmHg, or left ventricular end diastolic pressure (LVEDP) ≥ 15 mmHg documented during catheterization at rest, or PA diastolic pressure measured by implantable monitor ≥ 15 mmHg, or pulmonary wedge pressure or LVEDP ≥ 25 mmHg documented during catheterization at exercise
- •For participants with a prior diagnosis of T2DM at screening: Treatment of T2DM with diet, exercise, and/or glucose-lowering medications according to local label with stable dosing for at least 30 days before randomization
排除标准
- •History of any of the following within 60 days before screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke
- •Any of the following psychiatric history: -History of unstable major depressive disorder or other severe psychiatric disorder within 2 years before screening -Lifetime history of suicide attempt -History of non-suicidal self-injury within 5 years before screening.
- •History of malignancy within the last 5 years before screening.
- •History of chronic pancreatitis
- •Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma or MEN-2
- •eGFR < 20 mL/min/1.73 m2 according to the 2021 CKD-EPI creatinine (Cr)-cystatin C equation or receiving dialysis at screening
- •Obesity induced by specific endocrinologic disorders or monogenetic or syndromic forms of obesity
- •Planned bariatric surgery at the time of screening, or within 180 days of Screening
- •History of acute pancreatitis in the 180 days before screening
- •Heart failure due to: hypertrophic cardiomyopathy (obstructive and non obstructive), infiltrative cardiomyopathy (including cardiac sarcoid, lymphoma, cardiac amyloid, endomyocardial fibrosis), active myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular heart disease, or clinically significant congenital heart disease
- •Any lifetime history of LVEF ≤ 40%
- •Currently hospitalized with acute decompensated HF at the time of screening
- •Recipient of heart transplant or any other major organ transplant, listed for heart transplant, or anticipated to receive chronic mechanical circulatory support or heart transplantation within 12 months from randomization
- •Severe, concomitant disease that is expected to reduce life expectancy to < 1 year
- •History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the study.
- •Use of any GLP-1 RA, GIP agonists or antagonists, or amylin analogs within 90 days before randomization or planned use during the conduct of the study
- •Treatment with continuous SC insulin therapy at screening or participants on intensified insulin therapy who practice carbohydrate counting for bolus insulin dose adjustment.
- •Use within 90 days before randomization of medications prescribed for weight loss
- •In the opinion of the investigator, use within 90 days before randomization of medications that may cause significant weight gain
- •Currently receiving treatment in another investigational device or drug study, or less than 90 days (or 5 half-lives, whichever is longer) since ending treatment in another investigational device or drug study(ies).
- •Previous participation in a study that includes maridebart cafraglutide or AMG 598
- •Hospitalization with a primary diagnosis of decompensated HF which required IV loop diuretic treatment, within 30 days before screening
- •Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes
- •For participants with a prior diagnosis of T2DM at screening: -HbA1c > 10.0% (86 mmol/mol) at screening -Uncontrolled diabetes requiring immediate therapy at randomization in the judgement of the investigator -History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before screening -One or more episodes of severe hypoglycemia within 6 months before screening and/or history of hypoglycemia unawareness -History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.
- •SBP ≥ 180 mmHg at entry, or on three or more blood pressure-lowering drugs with a SBP > 160 mmHg
- •Calcitonin ≥ 50 ng/L (pg/mL) at screening
- •Acute or chronic hepatitis; signs and symptoms of any liver disease other than MSALD; or ALT > 3.0 x ULN, or TBL > 1.8 x ULN
- •Clinically significant gastric-emptying abnormality
结局指标
主要结局
Time to first occurrence of a composite endpoint consisting of: o CV death, or o hospitalization for HF, or o urgent HF visits
Time to first occurrence of a composite endpoint consisting of: o CV death, or o hospitalization for HF, or o urgent HF visits
次要结局
- Change from baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) at week 48 for participants with baseline KCCQ-CSS score ≤ 80
- Change from baseline in the KCCQ Total Symptom Score (TSS) at week 48 for participants with baseline KCCQ-CSS score ≤80
- Total HF events (first and recurrent time to event) (ReHF events)
- Time to first occurrence of a composite endpoint consisting of: myocardial infarction (MI), ischemic stroke, CV death (major adverse cardiac events [MACE]), or HF events
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (272)
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