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.

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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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

731

Study ID:

NCT04847557

Recruitment Status:

Active, not recruiting

Sponsor:

Eli Lilly and Company

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There are 138 Locations for this study

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Heart Center Research
Huntsville Alabama, 35801, United States
Westside Medical Associates of Los Angeles
Beverly Hills California, 90211, United States
Valley Clinical Trials, Inc.
Covina California, 91723, United States
Amicis Research Center
Granada Hills California, 91344, United States
University of California San Diego - La Jolla
La Jolla California, 92037, United States
Valley Clinical Trials, Inc.
Northridge California, 91325, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance California, 90502, United States
South Denver Cardiology Associates
Littleton Colorado, 80120, United States
Cardiology Associates of Fairfield County, P.C.
Stamford Connecticut, 06905, United States
Excel Medical Clinical Trials
Boca Raton Florida, 33434, United States
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
Clearwater Florida, 33756, United States
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
Largo Florida, 33777, United States
Infinite Clinical Research
Miami Florida, 33133, United States
Ocala Caridovascular Research
Ocala Florida, 34471, United States
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
Safety Harbor Florida, 34695, United States
East Coast Institute for Research - St. Augustine
Saint Augustine Florida, 32086, United States
Morehouse School Of Medicine
Atlanta Georgia, 30310, United States
St. Luke's Boise Medical Center
Boise Idaho, 83712, United States
Northwest Heart Clinical Research
Arlington Heights Illinois, 60005, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
Cardiovascular Research of Northwest Indiana
Munster Indiana, 46321, United States
Midwest Heart & Vascular Specialists
Overland Park Kansas, 66211, United States
Grace Research - Bossier
Bossier City Louisiana, 71111, United States
The Heart Clinic - Hammond
Hammond Louisiana, 70403, United States
Grace Research - Shreveport
Shreveport Louisiana, 71105, United States
Maryland Cardiovascular Specialists
Baltimore Maryland, 21229, United States
McLaren Bay Region
Bay City Michigan, 48708, United States
St. Louis Heart and Vascular, P.C.
Saint Louis Missouri, 63136, United States
Palm Research Center Tenaya
Las Vegas Nevada, 89128, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights New Jersey, 08035, United States
Lovelace Medical Center
Albuquerque New Mexico, 87102, United States
Erie County Medical Center
Buffalo New York, 14215, United States
Rochester General Hospital
Rochester New York, 14621, United States
Saratoga Cardiology Associates
Saratoga Springs New York, 12866, United States
Stony Brook University
Stony Brook New York, 11794, United States
OnSite Clinical Solutions
Charlotte North Carolina, 28277, United States
Aultman Hospital
Canton Ohio, 44710, United States
Rama Research
Marion Ohio, 43302, United States
Hightower Clinical Trial Services
Oklahoma City Oklahoma, 73102, United States
Hillsboro Cardiology
Hillsboro Oregon, 97123, United States
Capital Area Research, LLC
Camp Hill Pennsylvania, 17011, United States
Doylestown Hospital
Doylestown Pennsylvania, 18901, United States
UPMC Clinical Trials
Pittsburgh Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Monument Health Rapid City Hospital
Rapid City South Dakota, 57701, United States
The Stern Cardiovascular Foundation
Germantown Tennessee, 38138, United States
Apex Research Foundation
Jackson Tennessee, 38301, United States
DiscoveResearch
Beaumont Texas, 77701, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
North Dallas Research Associates
McKinney Texas, 75069, United States
Sherman Clinical Research
Sherman Texas, 75092, United States
Northwest Houston Heart Center
Tomball Texas, 77375, United States
Intermountain Medical Center
Murray Utah, 84107, United States
MultiCare Good Samaritan Hospital
Puyallup Washington, 98372, United States
DIM Clínica Privada
Ramos Mejía Buenos Aires, 1704, Argentina
Go Centro Medico San Nicolás
San Nicolas Buenos Aires, 2900, Argentina
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire Buenos Air, C1027, Argentina
Instituto Médico Especializado (IME)
Buenos Aires Ciudad Autónoma De Buenos Aires, 1405, Argentina
Mautalen Salud e Investigación
Buenos Aires Ciudad Autónoma De Buenos Aires, C1128, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aires Ciudad Autónoma De Buenos Aires, C1425, Argentina
CIPREC
Buenos Aires Ciudad Autónoma De Buenos Aire, C1061, Argentina
Instituto Médico Río Cuarto
Río Cuarto Córdoba, 5800, Argentina
Instituto de Investigaciones Clinicas Rosario
Rosario Santa Fe, S2000, Argentina
CEMEDIC
Buenos Aires , 1407, Argentina
Fundación Respirar
Buenos Aires , 1426, Argentina
Instituto de Cardiología "Juana F. Cabral"
Corrientes , 3400, Argentina
Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)
Córdoba , X5002, Argentina
Hospital de Alta Complejidad "Pte. Juan Domingo Perón"
Formosa , 3600, Argentina
Centro Cardiovascular Salta
Salta , 4406, Argentina
Instituto Cardiovascular San Luis
San Luis , 5700, Argentina
Centro de Investigaciones Clinicas del Litoral
Santa Fe , 3000, Argentina
Universidade Federal de Goias
Goiania Goiás, 74605, Brazil
Hospital Angelina Caron
Campina Grande do Sul Paraná, 83430, Brazil
Centro de Pesquisa Clinica do Coracao
Aracaju Sergipe, 49055, Brazil
Centro de Pesquisa Sao Lucas
Campinas São Paulo, 13034, Brazil
Loema Instituto de Pesquisa Clinica
Campinas São Paulo, 13092, Brazil
CAPED Centro Avancado Pesquisa e Diagnostica
Ribeirao Preto São Paulo, 14026, Brazil
Pesquisare Saude
Santo André São Paulo, 09080, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto São Paulo, 15090, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro , 22241, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo , 04266, Brazil
Peking University First Hospital
Beijing Beijing, 10003, China
Beijing Friendship Hospital
Beijing Beijing, 10005, China
The First Hospital of Harbin Medical University
Harbin Heilongjiang, 15000, China
Wuhan University Medical College - Hubei Zhongshan Hospital
Wuhan Hubei, 43000, China
The Third Xiangya Hospital of Central South University
Changsha Hunan, 41001, China
1st Hospital affiliate to Baotou medical college
Baotou Inner Mongolia, 01401, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing Jiangsu, 21000, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing Jiangsu, 21001, China
The Second Affiliated Hospital of Nanchang University
Nanchang Jiangxi, 33000, China
Jiangxi Pingxiang People's Hospital
Pingxiang Jiangxi, 33705, China
Jilin Province People's Hospital
Changchun Jilin, 13002, China
China-Japan Union Hospital
Changchun Jilin, 13003, China
The first affiliated hospital of dalian medical university
Dalian Liaoning, 11600, China
The People's Hospital of Liaoning Province
Shenyang Liaoning, 11000, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an Shaanxi, 71006, China
Jinan Central Hospital
Jinan Shandong, 25001, China
Zhongshan Hospital,Fudan University
Shanghai Shanghai, 20003, China
Huashan Hospital Affiliated Fudan University
Shanghai Shanghai, 20004, China
West China Hospital, Sichuan University
ChengDu Sichuan, 61004, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi Xinjiang, 83005, China
G.B. Pant Institute of Postgraduate Medical Education & Research
New Delhi Delhi, 11000, India
Batra Hospital and Medical Research Centre
New Delhi Delhi, 11006, India
CIMS Hospital - Care Institute of Medical Sciences
Ahmedabad Gujarat, 38006, India
Medanta The Medicity
Gurugramam Haryana, 12201, India
Narayana Institute of Cardiac Sciences
Bangalore Karnataka, 56009, India
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
Mumbai Maharashtra, 40001, India
Government Medical College And Hospital - Nagpur
Nagpur Maharashtra, 44000, India
Central India Cardiology and Research Institute
Nagpur Maharashtra, 44001, India
Vijan Hospital & Research Centre
Nashik Maharashtra, 42200, India
AIG Hospitals
Hyderabad Telangana, 50003, India
Barzilai Medical Center
Ashkelon HaDarom, 78306, Israel
Meir Medical Center
Kfar Saba HaMerkaz, 44281, Israel
Rabin Medical Center
Petah-Tikva HaMerkaz, , Israel
Sheba Medical Center
Ramat Gan HaMerkaz, 52621, Israel
Kaplan Medical Center
Rehovot HaMerkaz, 76100, Israel
Hillel Yaffe Medical Center
Hadera HaTsafon, 38101, Israel
Rambam Health Care Campus
Haifa HaTsafon, 31096, Israel
Galilee Medical Center
Nahariya HaTsafon, 22100, Israel
Sourasky Medical Center
Tel Aviv Tell Abīb, 64239, Israel
Shaare Zedek Medical Center
Jerusalem Yerushalayim, 90131, Israel
Hadassah Medical Center
Jerusalem Yerushalayim, 91120, Israel
CIMAB SA de CV
Torreón Coahuila, 27000, Mexico
Virgen Cardiovascular Research SC
Guadalajara Jalisco, 44670, Mexico
Cardiolink Clin Trials
Monterrey Nuevo León, 64060, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey Nuevo León, 66460, Mexico
Fundación Cardiovascular de Aguascalientes A.C.
Aguascalientes , 20230, Mexico
Hospital Cardiologica Aguescalientes
Aguascalientes , 20230, Mexico
Centro de Estudios Clínicos de Querétaro (CECLIQ)
Querétaro , 76000, Mexico
Clinical Research Center - Universidad Central del Caribe (CRC - UCC)
Bayamon , 00956, Puerto Rico
Ivanovo Regional Healthcare Institution Cardiology Dispensary
Ivanovo Ivanovskaya Oblast', 15301, Russian Federation
Russian Cardiology Research and Production Complex
Moscow Moskva, 12155, Russian Federation
Russian Medical Academy of Postgraduate Education
Moscow Moskva, 12599, Russian Federation
Ryazan Regional Clinical Cardiological Dispensary
Ryazan Ryazanskaya Oblast', 39002, Russian Federation
Astarta Clinic
Saint-Petersburg Sankt-Peterburg, 19922, Russian Federation
Izhevsk City Clinical Hospital Number 9
Izhevsk Udmurtskaya Respublika, 42606, Russian Federation
Chung Shan Medical University Hospital
Taichung City Taichung, 402, Taiwan
Mackay Memorial Hospital-Hsinchu
Hsinchu , 300, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , , Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Taipei Medical University Hospital
Taipei , 110, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan , 333, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

731

Study ID:

NCT04847557

Recruitment Status:

Active, not recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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