GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

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

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)

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

146

Recruiting sites

—

Enrollment

731

actual

Study population

Heart failure, Obesity / overweight

Key I/E criteria

•BMI ≥30•eGFR ≤70•EF ≥50%

Primary endpoints

•KCCQ clinical summary•Expanded / custom MACE composite (Cardiovascular death, Heart-failure hospitalization)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04847557

Org study ID17757

Secondary IDI8F-MC-GPIDEli Lilly and Company

Timeline

Milestones

Study first posted2021-04-19actual

Study start2021-04-20actual

Primary completion2024-07-02actual

Study completion2024-07-02actual

Last update posted2025-08-20actual

Results first posted2025-08-20actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Heart failureObesity / overweight

Eligibility

Who can enroll

Minimum age40 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (22)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Heart failure

Cardiovascular outcomes

Weight & body composition

Cardiometabolic biomarkers

Cardiovascular outcomes

6 endpoints

Primary/registry result

First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes

Time frame:Baseline Up To 160 weeks

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, Heart-failure hospitalization

Posted result

Group	Value (number), Number of events	95% CI
Tirzepatide - MTD	36	—
Placebo	56	—

Hazard Ratio (HR)0.6295% CI0.41 – 0.95p0.026Regression, Cox

Heart Failure Outcomes

Primary/protocol endpoint

First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes

Time frame:Baseline Up To 160 weeks

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, Heart-failure hospitalization

Secondary/registry result

Number of Participants With Time to All-Cause Death

Time frame:Baseline Up To 160 Weeks

All-cause death

time to event, event

SNOMED 419620001

Posted result

Group	Value (count_of_participants), Participants	95% CI
Tirzepatide - MTD	19	—
Placebo	15	—

Hazard Ratio (HR)1.24595% CI0.633 – 2.452

Secondary/registry result

Number of HF Events and All-Cause Death

Time frame:Baseline Up To 160 Weeks.

Expanded / custom MACE composite

event count, event

componentsHeart-failure hospitalization, All-cause death

Posted result

Group	Value (number), Events	95% CI
Tirzepatide - MTD	61	—
Placebo	82	—

Rate Ratio0.7295% CI0.46 – 1.14

Secondary/protocol endpoint

Number of Participants With Time to All-Cause Death

Time frame:Baseline Up To 160 Weeks

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Number of HF Events and All-Cause Death

Time frame:Baseline Up To 160 Weeks.

Expanded / custom MACE composite

event count, event

componentsHeart-failure hospitalization, All-cause death

Weight & body composition

2 endpoints

Secondary/registry result

Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Tirzepatide - MTD	-13.85	—
Placebo	-2.24	—

LS Mean Difference-11.6295% CI-12.85 – -10.38p<0.001ANCOVA

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, % change

percent change from baseline, improvement

Heart failure

12 endpoints

Primary/registry result

Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)

Time frame:Baseline, Week 52

KCCQ clinical summary

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	95% CI
Tirzepatide - MTD	19.51	—
Placebo	12.68	—

Median Difference (Net)6.995% CI3.3 – 10.6p<0.001Stratified Wilcoxon

Primary/protocol endpoint

Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)

Time frame:Baseline, Week 52

KCCQ clinical summary

change from baseline, improvement

Secondary/registry result

Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD)

Time frame:Baseline, Week 52

6-minute walk distance

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), meters	95% CI
Tirzepatide - MTD	26.04	—
Placebo	10.10	—

Median Difference (Net)18.395% CI9.9 – 26.7p<0.001Stratified Wilcoxon

Secondary/registry result

Win Percentage of the Hierarchical Composite Endpoint

Time frame:Baseline Up To 160 Weeks

composite event, event

componentsAll-cause death, Heart-failure hospitalization, Heart-failure composite, KCCQ clinical summary, 6-minute walk distance

Posted result

Group	Value (number), Win percentage	95% CI
Tirzepatide - MTD	57.90	—
Placebo	35.43	—

Win Ratio1.6395% CI1.17 – 2.28

Secondary/registry result

Percentage of Participants With New York Heart Association (NYHA) Class Change

Time frame:Week 52

NYHA class, change

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Tirzepatide - MTD	33.27	—
Placebo	20.39	—

Odds Ratio (OR)2.2895% CI1.53 – 3.40

Secondary/registry result

Number of Participants With Time to First Occurrence of HF Events

Time frame:Baseline Up To 160 Weeks

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Posted result

Group	Value (count_of_participants), Participants	95% CI
Tirzepatide - MTD	29	—
Placebo	52	—

Hazard Ratio (HR)0.53995% CI0.342 – 0.850

Secondary/registry result

Number of Recurrent HF Events

Time frame:Baseline Up To 160 Weeks.

Heart-failure hospitalization

event count, event

SNOMED 84114007

Posted result

Group	Value (number), Events	95% CI
Tirzepatide - MTD	44	—
Placebo	68	—

Rate Ratio0.6295% CI0.37 – 1.05

Secondary/protocol endpoint

Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD)

Time frame:Baseline, Week 52

6-minute walk distance

change from baseline, improvement

Secondary/protocol endpoint

Win Percentage of the Hierarchical Composite Endpoint

Time frame:Baseline Up To 160 Weeks

Heart-failure composite

composite event, event

componentsAll-cause death, Heart-failure hospitalization, KCCQ clinical summary, 6-minute walk distance

Secondary/protocol endpoint

Percentage of Participants With New York Heart Association (NYHA) Class Change

Time frame:Week 52

NYHA class, change

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants With Time to First Occurrence of HF Events

Time frame:Baseline Up To 160 Weeks

Heart-failure composite

time to event, event

SNOMED 84114007

Secondary/protocol endpoint

Number of Recurrent HF Events

Time frame:Baseline Up To 160 Weeks.

CV events (total recurrent)

event count, event

SNOMED 84114007

Cardiometabolic biomarkers

2 endpoints

Secondary/registry result

Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

Time frame:Baseline, Week 52

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
Tirzepatide - MTD	-38.76	—
Placebo	-5.88	—

LS Mean Difference-34.9195% CI-45.60 – -22.17p<0.001ANCOVA

Secondary/protocol endpoint

Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

Time frame:Baseline, Week 52

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Publications (7)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Influence of Type 2 Diabetes on the Effects of Tirzepatide in Patients With Heart Failure and a Preserved Ejection Fraction With Obesity: A Prespecified Stratification-Based Analysis.
Journal of the American College of Cardiology2025 Sep 9PMID40903131doi:10.1016/j.jacc.2025.06.058via clinicaltrials gov reference derived + pubmed nct search
Impact of Body Mass Index, Central Adiposity, and Weight Loss on the Benefits of Tirzepatide in HFpEF: The SUMMIT Trial.
Journal of the American College of Cardiology2025 Jul 29PMID40701669doi:10.1016/j.jacc.2025.04.059via clinicaltrials gov reference derived + pubmed nct search
Interplay of Chronic Kidney Disease and the Effects of Tirzepatide in Patients With Heart Failure, Preserved Ejection Fraction, and Obesity: The SUMMIT Trial.
Journal of the American College of Cardiology2025 May 13PMID40162940doi:10.1016/j.jacc.2025.03.009via clinicaltrials gov reference derived + pubmed nct search
Effects of Tirzepatide on the Clinical Trajectory of Patients With Heart Failure, Preserved Ejection Fraction, and Obesity.
Circulation2025 Mar 11PMID39556714doi:10.1161/CIRCULATIONAHA.124.072679via clinicaltrials gov reference derived + pubmed nct search
Tirzepatide Reduces LV Mass and Paracardiac Adipose Tissue in Obesity-Related Heart Failure: SUMMIT CMR Substudy.
Journal of the American College of Cardiology2025 Feb 25PMID39566869doi:10.1016/j.jacc.2024.11.001via clinicaltrials gov reference derived + pubmed nct search
Effects of tirzepatide on circulatory overload and end-organ damage in heart failure with preserved ejection fraction and obesity: a secondary analysis of the SUMMIT trial.
Nature medicine2025 Feb (month)PMID39551891doi:10.1038/s41591-024-03374-zvia clinicaltrials gov reference derived + pubmed nct search
Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity.
The New England journal of medicine2025 Jan 30PMID39555826doi:10.1056/NEJMoa2410027via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.