A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
- Status
- CompletedResults posted
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 40 Years to no upper limit; excludes diabetes; BMI ≥30 required; conditions: Obesity; Heart Failure With Preserved Ejection Fraction (HFpEF)
- Interventions
- Tirzepatide; Placebo
- Conditions
- Obesity; Heart Failure With Preserved Ejection Fraction (HFpEF)
- Phase and size
- Phase 3 · 731 participants
- Dates
- Start 2021-04-20
Primary completion 2024-07-02 - Sponsor
- Eli Lilly and Company (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)Baseline, Week 52
- First Occurrence of the Composite Endpoint of Heart Failure (HF) OutcomesBaseline Up To 160 weeks
Published results in the collection
- Tirzepatide for Heart Failure with Preserved Ejection Fraction and ObesityRandomized trial · 2025 · Study tier 2 · Different population · Benefit · Industry funded
- Effects of Tirzepatide in Obesity-Related HFpEF by Sex: A Prespecified Secondary Analysis From the SUMMIT TrialRandomized trial · 2026 · Study tier 2 · Different population · Mixed · Unreviewed automatic assessment
- Impact of Body Mass Index, Central Adiposity, and Weight Loss on the Benefits of Tirzepatide in HFpEF: The SUMMIT TrialRandomized trial · 2025 · Study tier 2 · Different population · Benefit · Unreviewed automatic assessment
- 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 trialRandomized trial · 2025 · Study tier 3 · Different population · Benefit · Unreviewed automatic assessment
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.