What NCT04847557 measured first
| Tirzepatide - MTDn=301 | Placebon=313 |
|---|---|
| 19.51(1.24) | 12.68(1.25) |
| Tirzepatide - MTDn=364 | Placebon=367 |
|---|---|
| 36 | 56 |
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)
Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) (Score on a scale), Baseline, Week 52. Tirzepatide - MTD: 19.51; Placebo: 12.68.
As posted on ClinicalTrials.gov (NCT04847557), updated at source Aug 20, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Tirzepatide - MTDn=301 | Placebon=313 |
|---|---|
| 19.51(1.24) | 12.68(1.25) |
| Tirzepatide - MTDn=364 | Placebon=367 |
|---|---|
| 36 | 56 |
Percent of participants affected, Baseline Up To 162 Weeks. The most common events the registry lists.
| Event | Tirzepatide - MTD | Placebo |
|---|---|---|
| Any serious event | 26.4% | 25.6% |
| Diarrhoea | 17.9% | 6.3% |
| Nausea | 17% | 6.3% |
| Constipation | 14.8% | 6% |
| Covid-19 | 9.1% | 11.2% |
| Vomiting | 10.4% | 1.9% |
| Decreased appetite | 10.4% | 1.6% |
| Dizziness | 9.3% | 4.9% |
| Urinary tract infection | 8.5% | 6% |
| Dyspepsia | 6.3% | 2.2% |
| Hypotension | 6% | 2.7% |
| Cardiac failure | 3% | 5.4% |
| Abdominal pain upper | 5.2% | 1.9% |
| Tirzepatide - MTDn=326 | Placebon=314 |
|---|---|
| 26.04(3.81) | 10.10(3.94) |
| Tirzepatide - MTDn=331 | Placebon=333 |
|---|---|
| -13.85(0.43) | -2.24(0.46) |
| Tirzepatide - MTDn=305 | Placebon=298 |
|---|---|
| -38.76(4.47) | -5.88(5.25) |
| Tirzepatide - MTDn=364 | Placebon=367 |
|---|---|
| 57.90 | 35.43 |
| Tirzepatide - MTDn=328 | Placebon=327 |
|---|---|
| 33.27 | 20.39 |
| Tirzepatide - MTDn=364 | Placebon=367 |
|---|---|
| 19 | 15 |
| Tirzepatide - MTDn=364 | Placebon=367 |
|---|---|
| 29 | 52 |
| Tirzepatide - MTDn=364 | Placebon=367 |
|---|---|
| 61 | 82 |
| Tirzepatide - MTDn=364 | Placebon=367 |
|---|---|
| 44 | 68 |
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.
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
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.