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

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)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Heart Failure With Preserved Ejection Fraction (HFpEF)
• Intervention / Treatment: Drug: Tirzepatide; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 731
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1407
    • CEMEDIC
  • Buenos Aires, Argentina, 1426
    • Fundación Respirar
  • Corrientes, Argentina, 3400
    • Instituto de Cardiología "Juana F. Cabral"
  • Córdoba, Argentina, X5002HWE
    • Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)
  • Formosa, Argentina, 3600
    • Hospital de Alta Complejidad "Pte. Juan Domingo Perón"
  • Salta, Argentina, 4406
    • Centro Cardiovascular Salta
  • San Luis, Argentina, 5700
    • Instituto Cardiovascular San Luis
  • Santa Fe, Argentina, 3000
    • Centro de Investigaciones Clínicas del Litoral
  • Buenos Air
    • Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina, C1027AAP
      • Centro de Investigaciones Metabólicas (CINME)
  • Buenos Aires
    • Ramos Mejía, Buenos Aires, Argentina, 1704
      • DIM Clinica Privada
    • San Nicolas, Buenos Aires, Argentina, 2900
      • Go Centro Medico San Nicolás
  • Ciudad Autónoma De Buenos Aire
    • Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina, C1061AAS
      • CIPREC
  • Ciudad Autónoma De Buenos Aires
    • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1128AAF
      • Mautalen Salud e Investigación
    • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, 1405
      • Instituto Médico Especializado (IME)
    • Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1425AGC
      • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
  • Córdoba
    • Río Cuarto, Córdoba, Argentina, 5800
      • Instituto Medico Rio Cuarto
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000CVD
      • Instituto de Investigaciones Clinicas Rosario
• Brazil
  • Rio de Janeiro, Brazil, 22241-180
    • IBPClin - Instituto Brasil de Pesquisa Clínica
  • São Paulo, Brazil, 04266-010
    • CEPIC - Centro Paulista de Investigacao Clinica
  • Goiás
    • Goiania, Goiás, Brazil, 74605-020
      • Universidade Federal de Goias
  • Paraná
    • Campina Grande do Sul, Paraná, Brazil, 83430-000
      • Hospital Angelina Caron
  • Sergipe
    • Aracaju, Sergipe, Brazil, 49055-530
      • Centro de Pesquisa Clínica do Coração
  • São Paulo
    • Campinas, São Paulo, Brazil, 13060-080
      • Instituto de Pesquisa Clinica de Campinas
    • Campinas, São Paulo, Brazil, 13034-685
      • Centro de Pesquisa São Lucas
    • Campinas, São Paulo, Brazil, 13092133
      • Loema Instituto de Pesquisa Clinica
    • Ribeirao Preto, São Paulo, Brazil, 14026-900
      • CAPED Centro Avancado Pesquisa e Diagnostica
    • Santo André, São Paulo, Brazil, 09080-110
      • Pesquisare Saude
    • São José do Rio Preto, São Paulo, Brazil, 15090000
      • Fundação Faculdade Regional de Medicina de São José do Rio Preto
• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Lanzhou University Second Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The First Hospital of Harbin Medical University
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Wuhan University Medical College - Hubei Zhongshan Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014010
      • 1st Hospital affiliate to Baotou medical college
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 210000
      • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The Second Affiliated Hospital of Nanchang University
    • Pingxiang, Jiangxi, China, 337055
      • Jiangxi Pingxiang People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • Jilin Province People's Hospital
    • Changchun, Jilin, China, 130033
      • China-Japan Union Hospital
  • Liaoning
    • Dalian, Liaoning, China, 116000
      • The First Affiliated Hospital of Dalian Medical University
    • Shenyang, Liaoning, China, 110000
      • The People's Hospital of Liaoning Province
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital,Fudan University
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital Affiliated Fudan University
  • Sichuan
    • ChengDu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830054
      • The first affiliated hospital of Xinjiang medical university
• India
  • Delhi
    • New Delhi, Delhi, India, 110002
      • G.B. Pant Institute of Postgraduate Medical Education & Research
    • New Delhi, Delhi, India, 110062
      • Batra Hospital and Medical Research Centre
  • Gujarat
    • Ahmedabad, Gujarat, India, 380060
      • CIMS Hospital - Care Institute of Medical Sciences
  • Haryana
    • Gurugramam, Haryana, India, 122018
      • Medanta The Medicity
  • Karnataka
    • Bangalore, Karnataka, India, 560099
      • Narayana Institute of Cardiac Sciences
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College
    • Nagpur, Maharashtra, India, 440009
      • Government Medical College And Hospital - Nagpur
    • Nagpur, Maharashtra, India, 440015
      • Central India Cardiology and Research Institute
    • Nashik, Maharashtra, India, 422005
      • Vijan Hospital & Research Centre
  • Telangana
    • Hyderabad, Telangana, India, 500032
      • AIG Hospitals
• Israel
  • HaDarom
    • Ashkelon, HaDarom, Israel, 7830604
      • Barzilai Medical Center
  • HaMerkaz
    • Kfar Saba, HaMerkaz, Israel, 4428164
      • Meir Medical Center
    • Petah-Tikva, HaMerkaz, Israel
      • Rabin Medical Center
    • Ramat Gan, HaMerkaz, Israel, 5262100
      • Sheba Medical Center
    • Rehovot, HaMerkaz, Israel, 7610001
      • Kaplan Medical Center
  • HaTsafon
    • Hadera, HaTsafon, Israel, 3810101
      • Hillel Yaffe Medical Center
    • Haifa, HaTsafon, Israel, 3109601
      • Rambam Health Care Campus
    • Nahariya, HaTsafon, Israel, 2210001
      • Galilee Medical Center
  • Tell Abīb
    • Tel Aviv, Tell Abīb, Israel, 6423906
      • Sourasky Medical Center
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 9112001
      • Hadassah Medical Center
    • Jerusalem, Yerushalayim, Israel, 9013102
      • Shaare Zedek Medical Center
• Mexico
  • Aguascalientes, Mexico, 20230
    • Hospital Cardiologica Aguescalientes
  • Aguascalientes, Mexico, 20230
    • Fundación Cardiovascular de Aguascalientes A.C.
  • Querétaro, Mexico, 76000
    • Centro de Estudios Clínicos de Querétaro (CECLIQ)
  • Coahuila
    • Torreón, Coahuila, Mexico, 27000
      • CIMAB SA de CV
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44670
      • Virgen Cardiovascular Research SC
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 66460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
    • Monterrey, Nuevo León, Mexico, 64060
      • Cardiolink Clin Trials
• Puerto Rico
  • Bayamon, Puerto Rico, 00956
    • Clinical Research Center - Universidad Central del Caribe (CRC - UCC)
  • Ponce, Puerto Rico, 00717
    • Research and Cardiovascular Corp.
• Russian Federation
  • Ivanovskaya Oblast'
    • Ivanovo, Ivanovskaya Oblast', Russian Federation, 153012
      • Ivanovo Regional Healthcare Institution Cardiology Dispensary
  • Moskva
    • Moscow, Moskva, Russian Federation, 121552
      • Russian Cardiology Research and Production Complex
    • Moscow, Moskva, Russian Federation, 125993
      • Russian Medical Academy of Postgraduate Education
  • Ryazanskaya Oblast'
    • Ryazan, Ryazanskaya Oblast', Russian Federation, 390026
      • Ryazan Regional Clinical Cardiological Dispensary
  • Sankt-Peterburg
    • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 199226
      • Astarta Clinic
  • Udmurtskaya Respublika
    • Izhevsk, Udmurtskaya Respublika, Russian Federation, 426063
      • Izhevsk City Clinical Hospital Number 9
• Taiwan
  • Hsinchu, Taiwan, 300
    • Mackay Memorial Hospital-Hsinchu
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch
  • Taichung
    • Taichung City, Taichung, Taiwan, 402
      • Chung Shan Medical University Hospital
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research
  • California
    • Beverly Hills, California, United States, 90211
      • Westside Medical Associates of Los Angeles
    • Covina, California, United States, 91723
      • Valley Clinical Trials, Inc.
    • Granada Hills, California, United States, 91344
      • Amicis Research Center
    • La Jolla, California, United States, 92037
      • University of California San Diego - La Jolla
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • Torrance, California, United States, 90502
      • The Lundquist Institute
  • Colorado
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Cardiology Associates of Fairfield County, P.C.
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Excel Medical Clinical Trials
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
    • Largo, Florida, United States, 33777
      • Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
    • Miami, Florida, United States, 33133
      • Infinite Clinical Research
    • Ocala, Florida, United States, 34471
      • Ocala Caridovascular Research
    • Safety Harbor, Florida, United States, 34695
      • Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
    • Saint Augustine, Florida, United States, 32086
      • East Coast Institute for Research - St. Augustine
  • Georgia
    • Atlanta, Georgia, United States, 30310
      • Morehouse School of Medicine
  • Idaho
    • Boise, Idaho, United States, 83712
      • St. Luke's Boise Medical Center
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Heart Clinical Research
    • Peoria, Illinois, United States, 61636
      • Methodist Medical Center of Illinois
  • Indiana
    • Munster, Indiana, United States, 46321
      • Cardiovascular Research of Northwest Indiana
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Midwest Heart & Vascular Specialists
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • Grace Research - Bossier
    • Hammond, Louisiana, United States, 70403
      • The Heart Clinic - Hammond
    • Shreveport, Louisiana, United States, 71105
      • Grace Research - Shreveport
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Maryland Cardiovascular Specialists
  • Michigan
    • Bay City, Michigan, United States, 48708
      • McLaren Bay Region
  • Missouri
    • Saint Louis, Missouri, United States, 63136
      • St. Louis Heart and Vascular, P.C.
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Palm Research Center Tenaya
  • New Jersey
    • Haddon Heights, New Jersey, United States, 08035
      • The Heart House
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Lovelace Medical Center
  • New York
    • Buffalo, New York, United States, 14215
      • Erie County Medical Center
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
    • Saratoga Springs, New York, United States, 12866
      • Saratoga Cardiology Associates
    • Stony Brook, New York, United States, 11794
      • Stony Brook University
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • OnSite Clinical Solutions
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital Research
    • Marion, Ohio, United States, 43302
      • Rama Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Hightower Clinical Trial Services
  • Oregon
    • Hillsboro, Oregon, United States, 97123
      • Hillsboro Cardiology
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Capital Area Research, LLC
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Clinical Trials
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health Rapid City Hospital
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The Stern Cardiovascular Foundation
    • Jackson, Tennessee, United States, 38301
      • Apex Research Foundation
  • Texas
    • Beaumont, Texas, United States, 77701
      • DiscoveResearch
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • McKinney, Texas, United States, 75069
      • North Dallas Research Associates
    • Sherman, Texas, United States, 75092
      • Sherman Clinical Research
    • Tomball, Texas, United States, 77375
      • Northwest Houston Heart Center
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Washington
    • Puyallup, Washington, United States, 98372
      • MultiCare Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 picogram/milliliter (pg/ml) for participants without atrial fibrillation (AF), or >600 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 100-425 meters
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tirzepatide; Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or maximum tolerated dose (MTD) tolerated by the participant (5 mg QW or 10 mg QW).	Drug: Tirzepatide; Administered SC; Other Names: LY3298176
Placebo Comparator: Placebo; Participants received placebo administered SC QW.	Other: Placebo; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)	The KCCQ is a 23-item, participant self-administered questionnaire that assesses impacts of heart failure "over the past 2 weeks" on the following 7 domains: Physical Limitation (6); Symptom Stability (1); Symptom Frequency (4); Symptom Burden (3); Self-Efficacy (2); Quality of Life (3); Social Limitation (4) Each of the 23 individual items are answered on Likert scales of varying lengths (5, 6, or 7-point scales). KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are obtained by averaging the associated individual items and transforming the score to a 0 to 100 range. Higher scores indicate better health status. Least Square (LS) mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (<35, >=35 kg/m2) + Treatment (Type III sum of squares) as variables .	Baseline, Week 52
First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes	Clinical Endpoint Committe confirmed Occurrences of CV outcomes were reported here. HF outcomes consisted of cardiovascular death and HF events. The HF events were defined as worsening clinical symptoms or signs related to HF, which are meaningful to the participant and require intensification of treatment characterized by 1 or more of the following: hospitalization for heart failure regardless of duration or treatment received; use of intravenous drug, usually an intravenous diuretic, but may include intravenous vasodilators or positive inotropic drugs, or; augmentation or increase in oral diuretic therapy.	Baseline Up To 160 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD)	Participants performed an exercise capacity assessment using the 6-Minute Walk Test (6MWT) and the distance covered (6MWD) was assessed in meters. The 6MWT was performed indoors on a straight, flat, hard surface that is at least 30 meters in length. The greater distance walked meant better physical capacity. LS Mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (<35, >=35 kg/m2) + Treatment (Type III sum of squares) as variables.	Baseline, Week 52
Percent Change From Baseline in Body Weight	Percent change in bodyweight was reported. LS mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (<35, >=35 kg/m2) + Treatment (Type III sum of squares) as variables.	Baseline, Week 52
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)	Percent change from baseline in hsCRP was reported. LS Mean was determined using ANCOVA model with log (actual measurement/baseline) = log (baseline) + HF decompensation within 12 months of screening + T2DM status + baseline BMI group (<35, >=35 kg/m2) + Treatment (Type III sum of squares) as variables.	Baseline, Week 52
Win Percentage of the Hierarchical Composite Endpoint	Hierarchical Composite Endpoint included time to all-cause death, number of HF events, time to first HF events, KCCQ-CSS, 6MWD. The winner was determined in each pair-wise comparison in the following order: A delayed first occurrence of all-cause death; If the pair cannot be differentiated based on death, winner has fewer HF events; If the pair cannot be differentiated by number of HF events, winner has delayed time to occurrence of first HF event; If the pair still cannot be differentiated, winner has a more favorable category for change from baseline in 6MWD; If the pair still cannot be differentiated, winner has a more favorable category for change from baseline in KCCQ-CSS; Otherwise the pair will be recorded as tied. Reported unit is the total percent of "wins" for each treatment group from performing such a hierarchical comparison across stratification factors in the study.	Baseline Up To 160 Weeks
Percentage of Participants With New York Heart Association (NYHA) Class Change	Percentage of participants with NYHA class change at Week 52 was reported.	Week 52
Number of Participants With Time to All-Cause Death	All-cause mortality is death due to any cause. Number of participants with time to all-cause mortality are presented.	Baseline Up To 160 Weeks
Number of Participants With Time to First Occurrence of HF Events	Number of participants with time to first occurrence of HF events are reported.	Baseline Up To 160 Weeks
Number of HF Events and All-Cause Death	Number of HF events and all-cause death are reported.	Baseline Up To 160 Weeks.
Number of Recurrent HF Events	Number of recurrent HF events were reported.	Baseline Up To 160 Weeks.

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): July 2, 2024
• Study Completion (Actual): July 2, 2024

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 15, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Heart Failure with Preserved Ejection Fraction (HFpEF)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Nutrition Disorders; Heart Diseases; Overnutrition; Body Weight; Overweight; Heart Failure; Obesity; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Tirzepatide
• Other Study ID Numbers: 17757 (REB); I8F-MC-GPID (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No