Status:
COMPLETED
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
Lead Sponsor:
Eli Lilly and Company
Conditions:
Obesity
Heart Failure With Preserved Ejection Fraction (HFpEF)
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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.
Detailed Description
The study will continue until approximately 52 weeks after the last participant is randomized. The maximum duration of an individual's participation is estimated to be \~120 weeks and will depend on d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2024
Estimated Enrollment :
731 Patients enrolled
Trial Details
Trial ID
NCT04847557
Start Date
April 20 2021
End Date
July 2 2024
Last Update
August 20 2025
Active Locations (146)
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1
Heart Center Research
Huntsville, Alabama, United States, 35801
2
Westside Medical Associates of Los Angeles
Beverly Hills, California, United States, 90211
3
Valley Clinical Trials, Inc.
Covina, California, United States, 91723
4
Amicis Research Center
Granada Hills, California, United States, 91344