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

Completed · Phase 3 · Has a placebo group

Conditions studied: Obesity, Heart Failure With Preserved Ejection Fraction (HFpEF)

In brief

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.

Key facts

Study ID

NCT04847557

Run by

Eli Lilly and Company

People needed

731

Starts

2021-04-20

Expected to finish

2024-07-02

Last updated by the study team

2025-08-20

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Westside Medical Associates of Los Angeles — Beverly Hills, California, United States
• Valley Clinical Trials, Inc. — Covina, California, United States
• Amicis Research Center — Granada Hills, California, United States
• University of California San Diego - La Jolla — La Jolla, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• The Lundquist Institute — Torrance, California, United States
• South Denver Cardiology Associates — Littleton, Colorado, United States
• Cardiology Associates of Fairfield County, P.C. — Stamford, Connecticut, United States
• Excel Medical Clinical Trials — Boca Raton, Florida, United States
• Clearwater Cardiovascular & Interventional Consultants M.D., P.A. — Clearwater, Florida, United States
• Clearwater Cardiovascular & Interventional Consultants M.D., P.A. — Largo, Florida, United States
• Infinite Clinical Research — Miami, Florida, United States
• Ocala Caridovascular Research — Ocala, Florida, United States
• Clearwater Cardiovascular & Interventional Consultants M.D., P.A. — Safety Harbor, Florida, United States
• East Coast Institute for Research - St. Augustine — Saint Augustine, Florida, United States
• Morehouse School Of Medicine — Atlanta, Georgia, United States
• St. Luke's Boise Medical Center — Boise, Idaho, United States
• Northwest Heart Clinical Research — Arlington Heights, Illinois, United States
• Methodist Medical Center of Illinois — Peoria, Illinois, United States
• Cardiovascular Research of Northwest Indiana — Munster, Indiana, United States
• Midwest Heart & Vascular Specialists — Overland Park, Kansas, United States
• Grace Research - Bossier — Bossier City, Louisiana, United States
• The Heart Clinic - Hammond — Hammond, Louisiana, United States
• Grace Research - Shreveport — Shreveport, Louisiana, United States
• Heart Center Research — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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