Phase 3 · Tirzepatide

NCT04847557 trial results

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.

Participants
731
Status
completed
Completed
2024-07-02
Sponsor
Eli Lilly and Company

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.

Primary outcome

What NCT04847557 measured first

Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)Score on a scale · Baseline, Week 52 · least squares mean
Tirzepatide - MTDn=301Placebon=313
19.51(1.24)12.68(1.25)
First Occurrence of the Composite Endpoint of Heart Failure (HF) OutcomesNumber of events · Baseline Up To 160 weeks · number
Tirzepatide - MTDn=364Placebon=367
3656
Side effects by arm

Side effects in NCT04847557

Percent of participants affected, Baseline Up To 162 Weeks. The most common events the registry lists.

EventTirzepatide - MTDPlacebo
Any serious event26.4%25.6%
Diarrhoea17.9%6.3%
Nausea17%6.3%
Constipation14.8%6%
Covid-199.1%11.2%
Vomiting10.4%1.9%
Decreased appetite10.4%1.6%
Dizziness9.3%4.9%
Urinary tract infection8.5%6%
Dyspepsia6.3%2.2%
Hypotension6%2.7%
Cardiac failure3%5.4%
Abdominal pain upper5.2%1.9%
Secondary outcomes

What else it measured

Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD)meters · Baseline, Week 52 · least squares mean
Tirzepatide - MTDn=326Placebon=314
26.04(3.81)10.10(3.94)
Percent Change From Baseline in Body WeightPercent change · Baseline, Week 52 · least squares mean
Tirzepatide - MTDn=331Placebon=333
-13.85(0.43)-2.24(0.46)
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)Percent change · Baseline, Week 52 · least squares mean
Tirzepatide - MTDn=305Placebon=298
-38.76(4.47)-5.88(5.25)
Win Percentage of the Hierarchical Composite EndpointWin percentage · Baseline Up To 160 Weeks · number
Tirzepatide - MTDn=364Placebon=367
57.9035.43
Percentage of Participants With New York Heart Association (NYHA) Class ChangePercentage of participants · Week 52 · number
Tirzepatide - MTDn=328Placebon=327
33.2720.39
Number of Participants With Time to All-Cause DeathParticipants · Baseline Up To 160 Weeks · count of participants
Tirzepatide - MTDn=364Placebon=367
1915
Number of Participants With Time to First Occurrence of HF EventsParticipants · Baseline Up To 160 Weeks · count of participants
Tirzepatide - MTDn=364Placebon=367
2952
Number of HF Events and All-Cause DeathEvents · Baseline Up To 160 Weeks. · number
Tirzepatide - MTDn=364Placebon=367
6182
Number of Recurrent HF EventsEvents · Baseline Up To 160 Weeks. · number
Tirzepatide - MTDn=364Placebon=367
4468
The trial

How NCT04847557 was run

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.

  • Tirzepatide: Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or maximum tolerated dose (MTD) tolerated by the participant (5 mg QW or 10 mg QW).
  • Placebo: Participants received placebo administered SC QW.
Who could join the trial

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

Published papers

Papers from NCT04847557

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.