CTRI/2022/01/039282已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide versus Placebo in Patients with Heart Failure with Preserved Ejection Fraction and Obesity (SUMMIT)
Eli Lilly and Company India Pvt Ltd10 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2022年12月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 10
- 主要终点
- 1. A Hierarchical Composite of All-Cause Mortality, Heart Failure Events, 6-minute Walk Test Distance (6MWD) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Category.
研究概览
简要总结
The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50%.
- •Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) > 200 pg/ml for participants without atrial fibrillation (AF), or >600 picogram/milliliter (pg/ml) for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure.
- •Estimated glomerular filtration rate (eGFR) <70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening.
- •4.Stable dose of heart failure medications within 4 weeks of screening.
- •Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²).
- •6MWD 100-425m.
- •KCCQ CSS ≤80.
排除标准
- •Have had a major cardiovascular event within the last 90 days of screening.
- •Have had acute decompensated heart failure within 4 weeks of screening.
- •Have non cardiac causes of functional impairment such as pulmonary arterial hypertension (PAH), severe chronic obstructive pulmonary disease (COPD), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions.
- •Presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular hear disease.
- •HbA1c ≥9.5% or uncontrolled diabetes.
- •History of proliferative diabetic retinopathy or diabetic maculopathy.
- •Have a history of pancreatitis.
- •eGFR <15 mL/min/1.73 m² or requiring dialysis at screening.
结局指标
主要结局
1. A Hierarchical Composite of All-Cause Mortality, Heart Failure Events, 6-minute Walk Test Distance (6MWD) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Category.
时间窗: 1. 120 Weeks. | 2. Week 52
2. Change from Baseline in Exercise Capacity as Measured by 6MWD
时间窗: 1. 120 Weeks. | 2. Week 52
次要结局
- 1. Percent Change from Baseline in Body Weight Loss.(2. Change from Baseline in the KCCQ CSS.)
- Percentage of Participants with New York Heart Association (NYHA) Class Change.(Week 52)
- Change from Baseline in 6MWD.(Baseline Week 24)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
3 期
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT TrialHeart Failure With Preserved Ejection Fraction (HFpEF)ObesityNCT04847557Eli Lilly and Company731
已完成
3 期
A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or BothType2 DiabetesT2DT2DM (Type 2 Diabetes Mellitus)Glucose Metabolism DisordersEndocrine System DiseasesMetabolic DiseaseDiabetes MellitusDiabetes Mellitus, Type 2NCT05260021Eli Lilly and Company99
已完成
3 期
A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)Type 2 DiabetesNCT05963022Eli Lilly and Company206
进行中（未招募）
3 期
A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With ObesityObesityOverweightNCT05556512Eli Lilly and Company15,374
已完成
3 期
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise AloneType 2 Diabetes MellitusNCT03954834Eli Lilly and Company478