Back to resultsA Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)
Primary Purpose
Obesity, Heart Failure With Preserved Ejection Fraction
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Heart Failure with Preserved Ejection Fraction (HFpEF)
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 hear 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
Sites / Locations
- Heart Center Research
- Westside Medical Associates of Los Angeles
- Valley Clinical Trials, Inc.
- Amicis Research Center
- Valley Clinical Trials, Inc.
- South Denver Cardiology Associates
- Cardiology Associates of Fairfield County, P.C.
- Excel Medical Clinical Trials
- Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
- Infinite Clinical Research
- Ocala Caridovascular Research
- Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
- East Coast Institute for Research - St. Augustine
- Morehouse School Of Medicine
- Northwest Heart Clinical Research
- Methodist Medical Center of Illinois
- Cardiovascular Research of Northwest Indiana
- Grace Research - Bossier
- The Heart Clinic - Hammond
- Grace Research - Shreveport
- Maryland Cardiovascular Specialists
- Cardiovascular Associates of the Delaware Valley
- Lovelace Medical Center
- Rochester General Hospital
- OnSite Clinical Solutions
- Aultman Hospital
- Rama Research
- Hightower Clinical Trial Services
- Hillsboro Cardiology
- Doylestown Hospital
- Medical University of South Carolina
- Monument Health Rapid City Hospital
- The Stern Cardiovascular Foundation
- Apex Research Foundation
- DiscoveResearch
- UT Southwestern Medical Center
- North Dallas Research Associates
- Sherman Clinical Research
- MultiCare Good Samaritan Hospital
- Centro de Investigaciones Metabólicas (CINME)
- CIPREC
- Instituto Médico Río Cuarto
- Instituto de Investigaciones Clinicas Rosario
- Hospital de Alta Complejidad "Pte. Juan Domingo Perón"
- Hospital Angelina Caron
- Centro de Pesquisa Clinica do Coracao
- Centro de Pesquisa Sao Lucas
- Loema Instituto de Pesquisa Clinica
- CAPED Centro Avancado Pesquisa e Diagnostica
- Pesquisare Saude
- IBPClin - Instituto Brasil de Pesquisa Clínica
- Lanzhou university second hospital
- The First Hospital of Harbin Medical University
- The First Affiliated Hospital of Xi'an Jiaotong University
- Zhongshan Hospital,Fudan University
- The First Affiliated Hospital of Xinjiang Medical University
- G.B. Pant Institute of Postgraduate Medical Education & Research
- CIMS Hospital - Care Institute of Medical Sciences
- Medanta The Medicity
- Narayana Institute of Cardiac Sciences
- Vijan Hospital & Research Centre
- Sourasky Medical Center
- CIMAB SA de CV
- Virgen Cardiovascular Research SC
- Cardiolink Clin Trials
- Fundación Cardiovascular de Aguascalientes A.C.
- Hospital Cardiologica Aguescalientes
- Centro de Estudios Clínicos de Querétaro (CECLIQ)
- Clinical Research Center - Universidad Central del Caribe (CRC - UCC)
- Research and Cardiovascular Corp.
- Ivanovo Regional Healthcare Institution Cardiology Dispensary
- Russian Cardiology Research and Production Complex
- Astarta Clinic
- Mackay Memorial Hospital-Hsinchu
- Chung Shan Medical University Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Taipei Medical University Hospital
- Taipei Veterans General Hospital
- Chang Gung Medical Foundation-Linkou Branch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tirzepatide
Placebo
Arm Description
Tirzepatide administered subcutaneously (SC)
Placebo administered SC
Outcomes
Primary Outcome Measures
A Hierarchical Composite of All-Cause Mortality, Heart Failure Events, 6-minute Walk Test Distance (6MWD) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Category
Hierarchical Composite of Time to All-Cause Mortality, Number of Heart Failure Events, Time to First HF Events, 6MWD, and KCCQ CSS 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.
Change from Baseline in Exercise Capacity as Measured by 6MWD
Secondary Outcome Measures
Percent Change from Baseline in Body Weight Loss
Change from Baseline in the KCCQ CSS
Change from Baseline in 6MWD
Percentage of Participants with New York Heart Association (NYHA) Class Change
Time to First Occurrence of HF Events or Cardiovascular (CV) Death
Time to First Occurrence of HF Events or All-Cause Death
Time to First Occurrence of HF Events
Time to Recurrent Events of HF Events and CV Death
Time to Recurrent Events of HF Events
Full Information
NCT ID
NCT04847557
First Posted
February 26, 2021
Last Updated
October 19, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT04847557
Brief Title
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity
Acronym
SUMMIT
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Heart Failure With Preserved Ejection Fraction
Keywords
Heart Failure with Preserved Ejection Fraction (HFpEF)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tirzepatide
Arm Type
Experimental
Arm Description
Tirzepatide administered subcutaneously (SC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
A Hierarchical Composite of All-Cause Mortality, Heart Failure Events, 6-minute Walk Test Distance (6MWD) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Category
Description
Hierarchical Composite of Time to All-Cause Mortality, Number of Heart Failure Events, Time to First HF Events, 6MWD, and KCCQ CSS 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.
Time Frame
Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks)
Title
Change from Baseline in Exercise Capacity as Measured by 6MWD
Time Frame
Baseline, Week 52
Secondary Outcome Measure Information:
Title
Percent Change from Baseline in Body Weight Loss
Time Frame
Baseline, Week 52
Title
Change from Baseline in the KCCQ CSS
Time Frame
Baseline, Week 52
Title
Change from Baseline in 6MWD
Time Frame
Baseline, Week 24
Title
Percentage of Participants with New York Heart Association (NYHA) Class Change
Time Frame
Week 52
Title
Time to First Occurrence of HF Events or Cardiovascular (CV) Death
Time Frame
Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks)
Title
Time to First Occurrence of HF Events or All-Cause Death
Time Frame
Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks)
Title
Time to First Occurrence of HF Events
Time Frame
Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks)
Title
Time to Recurrent Events of HF Events and CV Death
Time Frame
Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks)
Title
Time to Recurrent Events of HF Events
Time Frame
Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 hear 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Heart Center Research
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Westside Medical Associates of Los Angeles
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Amicis Research Center
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
South Denver Cardiology Associates
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Cardiology Associates of Fairfield County, P.C.
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Excel Medical Clinical Trials
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Infinite Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Ocala Caridovascular Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
East Coast Institute for Research - St. Augustine
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
Morehouse School Of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30310
Country
United States
Facility Name
Northwest Heart Clinical Research
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
Cardiovascular Research of Northwest Indiana
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Grace Research - Bossier
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Facility Name
The Heart Clinic - Hammond
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
Grace Research - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Maryland Cardiovascular Specialists
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Cardiovascular Associates of the Delaware Valley
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Facility Name
Lovelace Medical Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
OnSite Clinical Solutions
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Rama Research
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Hightower Clinical Trial Services
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Hillsboro Cardiology
City
Hillsboro
State/Province
Oregon
ZIP/Postal Code
97123
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Monument Health Rapid City Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
The Stern Cardiovascular Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Apex Research Foundation
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
DiscoveResearch
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
North Dallas Research Associates
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Sherman Clinical Research
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Facility Name
MultiCare Good Samaritan Hospital
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Air
ZIP/Postal Code
C1027AAP
Country
Argentina
Facility Name
CIPREC
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1061AAS
Country
Argentina
Facility Name
Instituto Médico Río Cuarto
City
Río Cuarto
State/Province
Córdoba
ZIP/Postal Code
5800
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000CVD
Country
Argentina
Facility Name
Hospital de Alta Complejidad "Pte. Juan Domingo Perón"
City
Formosa
ZIP/Postal Code
3600
Country
Argentina
Facility Name
Hospital Angelina Caron
City
Campina Grande do Sul
State/Province
Paraná
ZIP/Postal Code
83430-000
Country
Brazil
Facility Name
Centro de Pesquisa Clinica do Coracao
City
Acaraju
State/Province
Sergipe
ZIP/Postal Code
49055-530
Country
Brazil
Facility Name
Centro de Pesquisa Sao Lucas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13034-685
Country
Brazil
Facility Name
Loema Instituto de Pesquisa Clinica
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13092133
Country
Brazil
Facility Name
CAPED Centro Avancado Pesquisa e Diagnostica
City
Ribeirao Preto
State/Province
São Paulo
ZIP/Postal Code
14026-900
Country
Brazil
Facility Name
Pesquisare Saude
City
Santo André
State/Province
São Paulo
ZIP/Postal Code
09080-110
Country
Brazil
Facility Name
IBPClin - Instituto Brasil de Pesquisa Clínica
City
Rio de Janeiro
ZIP/Postal Code
22241-180
Country
Brazil
Facility Name
Lanzhou university second hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Facility Name
The First Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Zhongshan Hospital,Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Urumchi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
G.B. Pant Institute of Postgraduate Medical Education & Research
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
CIMS Hospital - Care Institute of Medical Sciences
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380060
Country
India
Facility Name
Medanta The Medicity
City
Gurugram
State/Province
Haryana
ZIP/Postal Code
122018
Country
India
Facility Name
Narayana Institute of Cardiac Sciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560099
Country
India
Facility Name
Vijan Hospital & Research Centre
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Facility Name
Sourasky Medical Center
City
Tel Aviv
State/Province
Tell Abīb
ZIP/Postal Code
6423906
Country
Israel
Facility Name
CIMAB SA de CV
City
Torreón
State/Province
Coahuila
ZIP/Postal Code
27000
Country
Mexico
Facility Name
Virgen Cardiovascular Research SC
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Cardiolink Clin Trials
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Fundación Cardiovascular de Aguascalientes A.C.
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Hospital Cardiologica Aguescalientes
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Centro de Estudios Clínicos de Querétaro (CECLIQ)
City
Querétaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Clinical Research Center - Universidad Central del Caribe (CRC - UCC)
City
Bayamon
ZIP/Postal Code
00956
Country
Puerto Rico
Facility Name
Research and Cardiovascular Corp.
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Ivanovo Regional Healthcare Institution Cardiology Dispensary
City
Ivanovo
State/Province
Ivanovskaya Oblast'
ZIP/Postal Code
153012
Country
Russian Federation
Facility Name
Russian Cardiology Research and Production Complex
City
Moscow
State/Province
Moskva
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Astarta Clinic
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
199226
Country
Russian Federation
Facility Name
Mackay Memorial Hospital-Hsinchu
City
Hsinchu City
State/Province
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Medical Foundation-Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share 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 URL
http://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/4deAJHqkMfFYm9JjtgeqTl
Description
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)
Learn more about this trial
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity
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