Clinical trial NCT04847557: A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Heart Failure With Preserved Ejection Fraction (HFpEF)
Keywords: Heart Failure with Preserved Ejection Fraction (HFpEF)
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 731
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
timeFrame: Baseline, Week 52
measure: Occurrence of the Composite Endpoint of Cardiovascular (CV) Death and/or Heart Failure (HF) Events Over Time
timeFrame: Baseline to Study Completion (estimated up to 120 weeks)
Secondary outcomes:
measure: Change from Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD)
timeFrame: Baseline, Week 52
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 52
measure: Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
timeFrame: Baseline, Week 52
measure: A hierarchical Composite of All-Cause Mortality, HF events, KCCQ-CSS, and 6MWD Category
timeFrame: Baseline to Study Completion (estimated up to 120 weeks)
measure: Percentage of Participants with New York Heart Association (NYHA) Class Change
timeFrame: Week 52
measure: Time to All-Cause Death
timeFrame: Baseline to Study Completion (estimated up to 120 weeks)
measure: Time to First Occurrence of HF Events
timeFrame: Baseline to Study Completion (estimated up to 120 weeks)
measure: Time to Recurrent HF Events and All-Cause Death
timeFrame: Baseline to Study Completion (estimated up to 120 weeks)
measure: Time to Recurrent HF Events
timeFrame: Baseline to Study Completion (estimated up to 120 weeks)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research
state: Alabama
city: Beverly Hills
country: United States
facility: Westside Medical Associates of Los Angeles
state: California
city: Covina
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Granada Hills
country: United States
facility: Amicis Research Center
state: California
city: La Jolla
country: United States
facility: University of California San Diego - La Jolla
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Torrance
country: United States
facility: The Lundquist Institute
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates
state: Colorado
city: Stamford
country: United States
facility: Cardiology Associates of Fairfield County, P.C.
state: Connecticut
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
state: Florida
city: Largo
country: United States
facility: Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
state: Florida
city: Miami
country: United States
facility: Infinite Clinical Research
state: Florida
city: Ocala
country: United States
facility: Ocala Caridovascular Research
state: Florida
city: Safety Harbor
country: United States
facility: Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
state: Florida
city: Saint Augustine
country: United States
facility: East Coast Institute for Research - St. Augustine
state: Florida
city: Atlanta
country: United States
facility: Morehouse School Of Medicine
state: Georgia
city: Boise
country: United States
facility: St. Luke's Boise Medical Center
state: Idaho
city: Arlington Heights
country: United States
facility: Northwest Heart Clinical Research
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Munster
country: United States
facility: Cardiovascular Research of Northwest Indiana
state: Indiana
city: Overland Park
country: United States
facility: Midwest Heart & Vascular Specialists
state: Kansas
city: Bossier City
country: United States
facility: Grace Research - Bossier
state: Louisiana
city: Hammond
country: United States
facility: The Heart Clinic - Hammond
state: Louisiana
city: Shreveport
country: United States
facility: Grace Research - Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: Maryland Cardiovascular Specialists
state: Maryland
city: Bay City
country: United States
facility: McLaren Bay Region
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular, P.C.
state: Missouri
city: Las Vegas
country: United States
facility: Palm Research Center Tenaya
state: Nevada
city: Haddon Heights
country: United States
facility: The Heart House
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Medical Center
state: New Mexico
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Saratoga Springs
country: United States
facility: Saratoga Cardiology Associates
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital Research
state: Ohio
city: Marion
country: United States
facility: Rama Research
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical Trial Services
state: Oklahoma
city: Hillsboro
country: United States
facility: Hillsboro Cardiology
state: Oregon
city: Camp Hill
country: United States
facility: Capital Area Research, LLC
state: Pennsylvania
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Clinical Trials
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health Rapid City Hospital
state: South Dakota
city: Germantown
country: United States
facility: The Stern Cardiovascular Foundation
state: Tennessee
city: Jackson
country: United States
facility: Apex Research Foundation
state: Tennessee
city: Beaumont
country: United States
facility: DiscoveResearch
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: McKinney
country: United States
facility: North Dallas Research Associates
state: Texas
city: Sherman
country: United States
facility: Sherman Clinical Research
state: Texas
city: Tomball
country: United States
facility: Northwest Houston Heart Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Puyallup
country: United States
facility: MultiCare Good Samaritan Hospital
state: Washington
city: Ramos Mejía
country: Argentina
facility: DIM Clínica Privada
state: Buenos Aires
city: San Nicolas
country: Argentina
facility: Go Centro Medico San Nicolás
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Air
city: Buenos Aires
country: Argentina
facility: Instituto Médico Especializado (IME)
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aire
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto
state: Córdoba
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas Rosario
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: CEMEDIC
city: Buenos Aires
country: Argentina
facility: Fundación Respirar
city: Corrientes
country: Argentina
facility: Instituto de Cardiología "Juana F. Cabral"
city: Córdoba
country: Argentina
facility: Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)
city: Formosa
country: Argentina
facility: Hospital de Alta Complejidad "Pte. Juan Domingo Perón"
city: Salta
country: Argentina
facility: Centro Cardiovascular Salta
city: San Luis
country: Argentina
facility: Instituto Cardiovascular San Luis
city: Santa Fe
country: Argentina
facility: Centro de Investigaciones Clinicas del Litoral
city: Goiania
country: Brazil
facility: Universidade Federal de Goias
state: Goiás
city: Campina Grande do Sul
country: Brazil
facility: Hospital Angelina Caron
state: Paraná
city: Aracaju
country: Brazil
facility: Centro de Pesquisa Clinica do Coracao
state: Sergipe
city: Campinas
country: Brazil
facility: Centro de Pesquisa Sao Lucas
state: São Paulo
city: Campinas
country: Brazil
facility: Instituto de Pesquisa clinica de Campinas
state: São Paulo
city: Campinas
country: Brazil
facility: Loema Instituto de Pesquisa Clinica
state: São Paulo
city: Ribeirao Preto
country: Brazil
facility: CAPED Centro Avancado Pesquisa e Diagnostica
state: São Paulo
city: Santo André
country: Brazil
facility: Pesquisare Saude
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: IBPClin - Instituto Brasil de Pesquisa Clínica
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Lanzhou
country: China
facility: Lanzhou university second hospital
state: Gansu
city: Harbin
country: China
facility: The First Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Wuhan University Medical College - Hubei Zhongshan Hospital
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Baotou
country: China
facility: 1st Hospital affiliate to Baotou medical college
state: Inner Mongolia
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Changchun
country: China
facility: China-Japan Union Hospital
state: Jilin
city: Dalian
country: China
facility: The first affiliated hospital of dalian medical university
state: Liaoning
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital,Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Affiliated Fudan University
state: Shanghai
city: ChengDu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: New Delhi
country: India
facility: G.B. Pant Institute of Postgraduate Medical Education & Research
state: Delhi
city: New Delhi
country: India
facility: Batra Hospital and Medical Research Centre
state: Delhi
city: Ahmedabad
country: India
facility: CIMS Hospital - Care Institute of Medical Sciences
state: Gujarat
city: Gurugramam
country: India
facility: Medanta The Medicity
state: Haryana
city: Bangalore
country: India
facility: Narayana Institute of Cardiac Sciences
state: Karnataka
city: Mumbai
country: India
facility: King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
state: Maharashtra
city: Nagpur
country: India
facility: Government Medical College And Hospital - Nagpur
state: Maharashtra
city: Nagpur
country: India
facility: Central India Cardiology and Research Institute
state: Maharashtra
city: Nashik
country: India
facility: Vijan Hospital & Research Centre
state: Maharashtra
city: Hyderabad
country: India
facility: AIG Hospitals
state: Telangana
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
state: HaDarom
city: Kfar Saba
country: Israel
facility: Meir Medical Center
state: HaMerkaz
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Rehovot
country: Israel
facility: Kaplan Medical Center
state: HaMerkaz
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
state: HaTsafon
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: HaTsafon
city: Nahariya
country: Israel
facility: Galilee Medical Center
state: HaTsafon
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
state: Tell Abīb
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Yerushalayim
city: Torreón
country: Mexico
facility: CIMAB SA de CV
state: Coahuila
city: Guadalajara
country: Mexico
facility: Virgen Cardiovascular Research SC
state: Jalisco
city: Monterrey
country: Mexico
facility: Cardiolink Clin Trials
state: Nuevo León
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Aguascalientes
country: Mexico
facility: Fundación Cardiovascular de Aguascalientes A.C.
city: Aguascalientes
country: Mexico
facility: Hospital Cardiologica Aguescalientes
city: Querétaro
country: Mexico
facility: Centro de Estudios Clínicos de Querétaro (CECLIQ)
city: Bayamon
country: Puerto Rico
facility: Clinical Research Center - Universidad Central del Caribe (CRC - UCC)
city: Ponce
country: Puerto Rico
facility: Research and Cardiovascular Corp.
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Healthcare Institution Cardiology Dispensary
state: Ivanovskaya Oblast'
city: Moscow
country: Russian Federation
facility: Russian Cardiology Research and Production Complex
state: Moskva
city: Moscow
country: Russian Federation
facility: Russian Medical Academy of Postgraduate Education
state: Moskva
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Cardiological Dispensary
state: Ryazanskaya Oblast'
city: Saint-Petersburg
country: Russian Federation
facility: Astarta Clinic
state: Sankt-Peterburg
city: Izhevsk
country: Russian Federation
facility: Izhevsk City Clinical Hospital Number 9
state: Udmurtskaya Respublika
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
state: Taichung
city: Hsinchu
country: Taiwan
facility: Mackay Memorial Hospital-Hsinchu
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: