Heart Failure Clinical Trial
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
Summary
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.
Full Description
The study will continue until approximately 52 weeks after the last participant is randomized. The maximum duration of an individual's participation is estimated to be ~120 weeks and will depend on duration of study enrollment.
Eligibility Criteria
Inclusion Criteria:
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,
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
Exclusion Criteria:
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 heart 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
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There are 142 Locations for this study
Huntsville Alabama, 35801, United States
Beverly Hills California, 90211, United States
Covina California, 91723, United States
Granada Hills California, 91344, United States
La Jolla California, 92037, United States
Northridge California, 91325, United States
Torrance California, 90502, United States
Littleton Colorado, 80120, United States
Stamford Connecticut, 06905, United States
Boca Raton Florida, 33434, United States
Clearwater Florida, 33756, United States
Largo Florida, 33777, United States
Miami Florida, 33133, United States
Ocala Florida, 34471, United States
Safety Harbor Florida, 34695, United States
Saint Augustine Florida, 32086, United States
Atlanta Georgia, 30310, United States
Boise Idaho, 83712, United States
Arlington Heights Illinois, 60005, United States
Peoria Illinois, 61636, United States
Munster Indiana, 46321, United States
Overland Park Kansas, 66211, United States
Bossier City Louisiana, 71111, United States
Hammond Louisiana, 70403, United States
Shreveport Louisiana, 71105, United States
Baltimore Maryland, 21229, United States
Bay City Michigan, 48708, United States
Saint Louis Missouri, 63136, United States
Las Vegas Nevada, 89128, United States
Haddon Heights New Jersey, 08035, United States
Albuquerque New Mexico, 87102, United States
Buffalo New York, 14215, United States
Rochester New York, 14621, United States
Saratoga Springs New York, 12866, United States
Stony Brook New York, 11794, United States
Charlotte North Carolina, 28277, United States
Canton Ohio, 44710, United States
Marion Ohio, 43302, United States
Oklahoma City Oklahoma, 73102, United States
Hillsboro Oregon, 97123, United States
Camp Hill Pennsylvania, 17011, United States
Doylestown Pennsylvania, 18901, United States
Pittsburgh Pennsylvania, 15213, United States
Charleston South Carolina, 29425, United States
Rapid City South Dakota, 57701, United States
Germantown Tennessee, 38138, United States
Jackson Tennessee, 38301, United States
Beaumont Texas, 77701, United States
Dallas Texas, 75390, United States
McKinney Texas, 75069, United States
Sherman Texas, 75092, United States
Tomball Texas, 77375, United States
Murray Utah, 84107, United States
Puyallup Washington, 98372, United States
Ramos Mejía Buenos Aires, 1704, Argentina
San Nicolas Buenos Aires, 2900, Argentina
Ciudad Autónoma de Buenos Aire Buenos Air, C1027, Argentina
Buenos Aires Ciudad Autónoma De Buenos Aires, 1405, Argentina
Buenos Aires Ciudad Autónoma De Buenos Aires, C1128, Argentina
Ciudad Autonoma de Buenos Aires Ciudad Autónoma De Buenos Aires, C1425, Argentina
Buenos Aires Ciudad Autónoma De Buenos Aire, C1061, Argentina
Río Cuarto Córdoba, 5800, Argentina
Rosario Santa Fe, S2000, Argentina
Buenos Aires , 1407, Argentina
Buenos Aires , 1426, Argentina
Corrientes , 3400, Argentina
Córdoba , X5002, Argentina
Formosa , 3600, Argentina
Salta , 4406, Argentina
San Luis , 5700, Argentina
Santa Fe , 3000, Argentina
Goiania Goiás, 74605, Brazil
Campina Grande do Sul Paraná, 83430, Brazil
Aracaju Sergipe, 49055, Brazil
Campinas São Paulo, 13034, Brazil
Campinas São Paulo, 13060, Brazil
Campinas São Paulo, 13092, Brazil
Ribeirao Preto São Paulo, 14026, Brazil
Santo André São Paulo, 09080, Brazil
São José do Rio Preto São Paulo, 15090, Brazil
Rio de Janeiro , 22241, Brazil
São Paulo , 04266, Brazil
Beijing Beijing, 10003, China
Beijing Beijing, 10005, China
Lanzhou Gansu, 73003, China
Harbin Heilongjiang, 15000, China
Wuhan Hubei, 43000, China
Changsha Hunan, 41001, China
Baotou Inner Mongolia, 01401, China
Nanjing Jiangsu, 21000, China
Nanjing Jiangsu, 21001, China
Nanchang Jiangxi, 33000, China
Pingxiang Jiangxi, 33705, China
Changchun Jilin, 13002, China
Changchun Jilin, 13003, China
Dalian Liaoning, 11600, China
Shenyang Liaoning, 11000, China
Xi'an Shaanxi, 71006, China
Jinan Shandong, 25001, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20004, China
ChengDu Sichuan, 61004, China
Ürümqi Xinjiang, 83005, China
New Delhi Delhi, 11000, India
New Delhi Delhi, 11006, India
Ahmedabad Gujarat, 38006, India
Gurugramam Haryana, 12201, India
Bangalore Karnataka, 56009, India
Mumbai Maharashtra, 40001, India
Nagpur Maharashtra, 44000, India
Nagpur Maharashtra, 44001, India
Nashik Maharashtra, 42200, India
Hyderabad Telangana, 50003, India
Ashkelon HaDarom, 78306, Israel
Kfar Saba HaMerkaz, 44281, Israel
Petah-Tikva HaMerkaz, , Israel
Ramat Gan HaMerkaz, 52621, Israel
Rehovot HaMerkaz, 76100, Israel
Hadera HaTsafon, 38101, Israel
Haifa HaTsafon, 31096, Israel
Nahariya HaTsafon, 22100, Israel
Tel Aviv Tell Abīb, 64239, Israel
Jerusalem Yerushalayim, 90131, Israel
Jerusalem Yerushalayim, 91120, Israel
Torreón Coahuila, 27000, Mexico
Guadalajara Jalisco, 44670, Mexico
Monterrey Nuevo León, 64060, Mexico
Monterrey Nuevo León, 66460, Mexico
Aguascalientes , 20230, Mexico
Aguascalientes , 20230, Mexico
Querétaro , 76000, Mexico
Bayamon , 00956, Puerto Rico
Ponce , 00717, Puerto Rico
Ivanovo Ivanovskaya Oblast', 15301, Russian Federation
Moscow Moskva, 12155, Russian Federation
Moscow Moskva, 12599, Russian Federation
Ryazan Ryazanskaya Oblast', 39002, Russian Federation
Saint-Petersburg Sankt-Peterburg, 19922, Russian Federation
Izhevsk Udmurtskaya Respublika, 42606, Russian Federation
Taichung City Taichung, 402, Taiwan
Hsinchu , 300, Taiwan
Kaohsiung , , Taiwan
Taipei , 10002, Taiwan
Taipei , 110, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 333, Taiwan
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