Phase 3
Completed N=731
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
Source: ClinicalTrials.gov NCT04847557 ↗Enrolled (actual)
731
Serious AEs
26.0%
Results posted
Aug 2025
Primary outcomePrimary: Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) — 19.51; 12.68 Score on a scale — p=<0.001
◆ Published Evidence
Highly cited
145citations · ~145 / year
Tirzepatide Reduces LV Mass and Paracardiac Adipose Tissue in Obesity-Related Heart Failure: SUMMIT CMR Substudy.
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.
Linked Publications (5)
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Tirzepatide Reduces LV Mass and Paracardiac Adipose Tissue in Obesity-Related Heart Failure: SUMMIT CMR Substudy.
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Effects of Tirzepatide on the Clinical Trajectory of Patients With Heart Failure, Preserved Ejection Fraction, and Obesity.
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Interplay of Chronic Kidney Disease and the Effects of Tirzepatide in Patients With Heart Failure, Preserved Ejection Fraction, and Obesity: The SUMMIT Trial.
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Impact of Body Mass Index, Central Adiposity, and Weight Loss on the Benefits of Tirzepatide in HFpEF: The SUMMIT Trial.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) |
19.51; 12.68 | <0.001 sig |
| PRIMARY First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes |
36; 56 | 0.026 sig |
| SECONDARY Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD) |
26.04; 10.10 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Body Weight |
-13.85; -2.24 | <0.001 sig |
| SECONDARY Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) |
-38.76; -5.88 | <0.001 sig |
| SECONDARY Win Percentage of the Hierarchical Composite Endpoint |
57.90; 35.43 | — |
| SECONDARY Percentage of Participants With New York Heart Association (NYHA) Class Change |
33.27; 20.39 | — |
| SECONDARY Number of Participants With Time to All-Cause Death |
19; 15 | — |
| SECONDARY Number of Participants With Time to First Occurrence of HF Events |
29; 52 | — |
| SECONDARY Number of HF Events and All-Cause Death |
61; 82 | — |
| SECONDARY Number of Recurrent HF Events |
44; 68 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT04847557) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.