A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
- Conditions
- ObesityHeart Failure With Preserved Ejection Fraction (HFpEF)
- Interventions
- Other: Placebo
- Registration Number
- NCT04847557
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 731
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered SC Tirzepatide Tirzepatide Tirzepatide administered subcutaneously (SC)
- Primary Outcome Measures
Name Time Method Change from Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Baseline, Week 52 Occurrence of the Composite Endpoint of Cardiovascular (CV) Death and/or Heart Failure (HF) Events Over Time Baseline to Study Completion (estimated up to 120 weeks)
- Secondary Outcome Measures
Name Time Method Change from Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD) Baseline, Week 52 Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) Baseline, Week 52 A hierarchical Composite of All-Cause Mortality, HF events, KCCQ-CSS, and 6MWD Category Baseline to Study Completion (estimated up to 120 weeks) Hierarchical Composite of Time to All-Cause Mortality, Number of Heart Failure Events, Time to First HF Events, KCCQ-CSS, and 6MWD will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of the components.
Percentage of Participants with New York Heart Association (NYHA) Class Change Week 52 Time to All-Cause Death Baseline to Study Completion (estimated up to 120 weeks) Percent Change from Baseline in Body Weight Baseline, Week 52 Time to First Occurrence of HF Events Baseline to Study Completion (estimated up to 120 weeks) Time to Recurrent HF Events and All-Cause Death Baseline to Study Completion (estimated up to 120 weeks) Time to Recurrent HF Events Baseline to Study Completion (estimated up to 120 weeks)
Trial Locations
- Locations (143)
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Northwest Houston Heart Center
🇺🇸Tomball, Texas, United States
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
Government Medical College And Hospital - Nagpur
🇮🇳Nagpur, Maharashtra, India
Narayana Institute of Cardiac Sciences
🇮🇳Bangalore, Karnataka, India
Central India Cardiology and Research Institute
🇮🇳Nagpur, Maharashtra, India
Infinite Clinical Research
🇺🇸Miami, Florida, United States
Maryland Cardiovascular Specialists
🇺🇸Baltimore, Maryland, United States
Palm Research Center Tenaya
🇺🇸Las Vegas, Nevada, United States
1st Hospital affiliate to Baotou medical college
🇨🇳Baotou, Inner Mongolia, China
Huashan Hospital Affiliated Fudan University
🇨🇳Shanghai, Shanghai, China
Amicis Research Center
🇺🇸Granada Hills, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Westside Medical Associates of Los Angeles
🇺🇸Beverly Hills, California, United States
Heart Center Research
🇺🇸Huntsville, Alabama, United States
South Denver Cardiology Associates
🇺🇸Littleton, Colorado, United States
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
🇺🇸Safety Harbor, Florida, United States
Northwest Heart Clinical Research
🇺🇸Arlington Heights, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Grace Research - Bossier
🇺🇸Bossier City, Louisiana, United States
Midwest Heart & Vascular Specialists
🇺🇸Overland Park, Kansas, United States
The Heart House
🇺🇸Haddon Heights, New Jersey, United States
Go Centro Medico San Nicolás
🇦🇷San Nicolas, Buenos Aires, Argentina
Saratoga Cardiology Associates
🇺🇸Saratoga Springs, New York, United States
Rama Research
🇺🇸Marion, Ohio, United States
Capital Area Research, LLC
🇺🇸Camp Hill, Pennsylvania, United States
UPMC Clinical Trials
🇺🇸Pittsburgh, Pennsylvania, United States
Monument Health Rapid City Hospital
🇺🇸Rapid City, South Dakota, United States
Stony Brook University
🇺🇸Stony Brook, New York, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
North Dallas Research Associates
🇺🇸McKinney, Texas, United States
DIM Clínica Privada
🇦🇷Ramos Mejía, Buenos Aires, Argentina
Sherman Clinical Research
🇺🇸Sherman, Texas, United States
IBPClin - Instituto Brasil de Pesquisa Clínica
🇧🇷Rio de Janeiro, Brazil
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Fundación Respirar
🇦🇷Buenos Aires, Argentina
Pesquisare Saude
🇧🇷Santo André, São Paulo, Brazil
Lanzhou university second hospital
🇨🇳Lanzhou, Gansu, China
The First Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Centro de Pesquisa Sao Lucas
🇧🇷Campinas, São Paulo, Brazil
CAPED Centro Avancado Pesquisa e Diagnostica
🇧🇷Ribeirao Preto, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
🇧🇷São José do Rio Preto, São Paulo, Brazil
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Instituto de Cardiología "Juana F. Cabral"
🇦🇷Corrientes, Argentina
Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)
🇦🇷Córdoba, Argentina
Hospital de Alta Complejidad "Pte. Juan Domingo Perón"
🇦🇷Formosa, Argentina
Instituto Cardiovascular San Luis
🇦🇷San Luis, Argentina
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Instituto de Pesquisa clinica de Campinas
🇧🇷Campinas, São Paulo, Brazil
Loema Instituto de Pesquisa Clinica
🇧🇷Campinas, São Paulo, Brazil
Wuhan University Medical College - Hubei Zhongshan Hospital
🇨🇳Wuhan, Hubei, China
G.B. Pant Institute of Postgraduate Medical Education & Research
🇮🇳New Delhi, Delhi, India
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Jiangxi Pingxiang People's Hospital
🇨🇳Pingxiang, Jiangxi, China
Jilin Province People's Hospital
🇨🇳Changchun, Jilin, China
West China Hospital, Sichuan University
🇨🇳ChengDu, Sichuan, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The first affiliated hospital of dalian medical university
🇨🇳Dalian, Liaoning, China
The People's Hospital of Liaoning Province
🇨🇳Shenyang, Liaoning, China
CIMS Hospital - Care Institute of Medical Sciences
🇮🇳Ahmedabad, Gujarat, India
Zhongshan Hospital,Fudan University
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Medanta The Medicity
🇮🇳Gurugramam, Haryana, India
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China
King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
🇮🇳Mumbai, Maharashtra, India
Russian Medical Academy of Postgraduate Education
🇷🇺Moscow, Moskva, Russian Federation
Galilee Medical Center
🇮🇱Nahariya, HaTsafon, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Sourasky Medical Center
🇮🇱Tel Aviv, Tell Abīb, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Russian Cardiology Research and Production Complex
🇷🇺Moscow, Moskva, Russian Federation
Vijan Hospital & Research Centre
🇮🇳Nashik, Maharashtra, India
Ryazan Regional Clinical Cardiological Dispensary
🇷🇺Ryazan, Ryazanskaya Oblast', Russian Federation
Astarta Clinic
🇷🇺Saint-Petersburg, Sankt-Peterburg, Russian Federation
Barzilai Medical Center
🇮🇱Ashkelon, HaDarom, Israel
Centro de Estudios Clínicos de Querétaro (CECLIQ)
🇲🇽Querétaro, Mexico
Research and Cardiovascular Corp.
🇵🇷Ponce, Puerto Rico
Ivanovo Regional Healthcare Institution Cardiology Dispensary
🇷🇺Ivanovo, Ivanovskaya Oblast', Russian Federation
Rabin Medical Center
🇮🇱Petah-Tikva, HaMerkaz, Israel
Kaplan Medical Center
🇮🇱Rehovot, HaMerkaz, Israel
Fundación Cardiovascular de Aguascalientes A.C.
🇲🇽Aguascalientes, Mexico
Cardiolink Clin Trials
🇲🇽Monterrey, Nuevo León, Mexico
Rambam Health Care Campus
🇮🇱Haifa, HaTsafon, Israel
Hightower Clinical Trial Services
🇺🇸Oklahoma City, Oklahoma, United States
Apex Research Foundation
🇺🇸Jackson, Tennessee, United States
Centro Cardiovascular Salta
🇦🇷Salta, Argentina
Centro de Investigaciones Clinicas del Litoral
🇦🇷Santa Fe, Argentina
Cardiovascular Research of Northwest Indiana
🇺🇸Munster, Indiana, United States
Grace Research - Shreveport
🇺🇸Shreveport, Louisiana, United States
The Heart Clinic - Hammond
🇺🇸Hammond, Louisiana, United States
McLaren Bay Region
🇺🇸Bay City, Michigan, United States
Doylestown Hospital
🇺🇸Doylestown, Pennsylvania, United States
St. Louis Heart and Vascular, P.C.
🇺🇸Saint Louis, Missouri, United States
Lovelace Medical Center
🇺🇸Albuquerque, New Mexico, United States
Aultman Hospital Research
🇺🇸Canton, Ohio, United States
Hillsboro Cardiology
🇺🇸Hillsboro, Oregon, United States
Erie County Medical Center
🇺🇸Buffalo, New York, United States
MultiCare Good Samaritan Hospital
🇺🇸Puyallup, Washington, United States
OnSite Clinical Solutions
🇺🇸Charlotte, North Carolina, United States
Sheba Medical Center
🇮🇱Ramat Gan, HaMerkaz, Israel
The Stern Cardiovascular Foundation
🇺🇸Germantown, Tennessee, United States
DiscoveResearch
🇺🇸Beaumont, Texas, United States
Mautalen Salud e Investigación
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Cardiology Associates of Fairfield County, P.C.
🇺🇸Stamford, Connecticut, United States
University of California San Diego - La Jolla
🇺🇸La Jolla, California, United States
The Lundquist Institute
🇺🇸Torrance, California, United States
St. Luke's Boise Medical Center
🇺🇸Boise, Idaho, United States
Ocala Caridovascular Research
🇺🇸Ocala, Florida, United States
East Coast Institute for Research - St. Augustine
🇺🇸Saint Augustine, Florida, United States
Morehouse School Of Medicine
🇺🇸Atlanta, Georgia, United States
CIPREC
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina
Instituto Médico Río Cuarto
🇦🇷Río Cuarto, Córdoba, Argentina
CEMEDIC
🇦🇷Buenos Aires, Argentina
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
China-Japan Union Hospital
🇨🇳Changchun, Jilin, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
Meir Medical Center
🇮🇱Kfar Saba, HaMerkaz, Israel
Hillel Yaffe Medical Center
🇮🇱Hadera, HaTsafon, Israel
Hospital Cardiologica Aguescalientes
🇲🇽Aguascalientes, Mexico
Clinical Research Center - Universidad Central del Caribe (CRC - UCC)
🇵🇷Bayamon, Puerto Rico
Izhevsk City Clinical Hospital Number 9
🇷🇺Izhevsk, Udmurtskaya Respublika, Russian Federation
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
Taipei Medical University Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan
Universidade Federal de Goias
🇧🇷Goiania, Goiás, Brazil
CIMAB SA de CV
🇲🇽Torreón, Coahuila, Mexico
Mackay Memorial Hospital-Hsinchu
🇨🇳Hsinchu, Taiwan
Instituto Médico Especializado (IME)
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Virgen Cardiovascular Research SC
🇲🇽Guadalajara, Jalisco, Mexico
AIG Hospitals
🇮🇳Hyderabad, Telangana, India
Chung Shan Medical University Hospital
🇨🇳Taichung City, Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Rosario
🇦🇷Rosario, Santa Fe, Argentina
Hospital Angelina Caron
🇧🇷Campina Grande do Sul, Paraná, Brazil
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽Monterrey, Nuevo León, Mexico
Rochester General Hospital
🇺🇸Rochester, New York, United States
Batra Hospital and Medical Research Centre
🇮🇳New Delhi, Delhi, India
Centro de Pesquisa Clinica do Coracao
🇧🇷Aracaju, Sergipe, Brazil
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Peking University First Hospital
🇨🇳Beijing, Beijing, China