A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial

Obesity Clinical 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04847557
• Other study ID #: 17757
• Secondary ID: I8F-MC-GPID
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 20, 2021
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 731
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction (HFpEF)
• Obesity

Intervention

Drug:
• Tirzepatide
Administered SC

Other:
• Placebo
Administered SC

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  China,  India,  Israel,  Mexico,  Puerto Rico,  Russian Federation,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)		Baseline, Week 52
Primary	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	Change from Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD)		Baseline, Week 52
Secondary	Percent Change from Baseline in Body Weight		Baseline, Week 52
Secondary	Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)		Baseline, Week 52
Secondary	A hierarchical Composite of All-Cause Mortality, HF events, KCCQ-CSS, and 6MWD Category	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.	Baseline to Study Completion (estimated up to 120 weeks)
Secondary	Percentage of Participants with New York Heart Association (NYHA) Class Change		Week 52
Secondary	Time to All-Cause Death		Baseline to Study Completion (estimated up to 120 weeks)
Secondary	Time to First Occurrence of HF Events		Baseline to Study Completion (estimated up to 120 weeks)
Secondary	Time to Recurrent HF Events and All-Cause Death		Baseline to Study Completion (estimated up to 120 weeks)
Secondary	Time to Recurrent HF Events		Baseline to Study Completion (estimated up to 120 weeks)

External Links

•   A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)