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

Phase 3

Completed

• Conditions: Obesity; Heart Failure With Preserved Ejection Fraction (HFpEF)
• Interventions: Other: Placebo; Drug: Tirzepatide

• Registration Number: NCT04847557
• Lead Sponsor: Eli Lilly and Company

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 duration of study enrollment.

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-19
• Study Start: 2021-04-20
• Status Verified: 2024-07
• Primary Completion: 2024-07-02
• Study Completion: 2024-07-02
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 731

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 pg/ml for participants without atrial fibrillation (AF), or >600 picogram/milliliter (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 100-425m
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered SC
Tirzepatide	Tirzepatide	Tirzepatide administered subcutaneously (SC)

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)	Baseline, Week 52
Occurrence of the Composite Endpoint of Cardiovascular (CV) Death and/or Heart Failure (HF) Events Over Time	Baseline to Study Completion (estimated up to 120 weeks)

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD)	Baseline, Week 52
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)	Baseline, Week 52
A hierarchical Composite of All-Cause Mortality, HF events, KCCQ-CSS, and 6MWD Category	Baseline to Study Completion (estimated up to 120 weeks)	Hierarchical Composite of Time to All-Cause Mortality, Number of Heart Failure Events, Time to First HF Events, KCCQ-CSS, and 6MWD will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of the components.
Percentage of Participants with New York Heart Association (NYHA) Class Change	Week 52
Time to All-Cause Death	Baseline to Study Completion (estimated up to 120 weeks)
Percent Change from Baseline in Body Weight	Baseline, Week 52
Time to First Occurrence of HF Events	Baseline to Study Completion (estimated up to 120 weeks)
Time to Recurrent HF Events and All-Cause Death	Baseline to Study Completion (estimated up to 120 weeks)
Time to Recurrent HF Events	Baseline to Study Completion (estimated up to 120 weeks)

Trial Locations

Locations (143)

Heart Center Research; 🇺🇸 Huntsville, Alabama, United States

Westside Medical Associates of Los Angeles; 🇺🇸 Beverly Hills, California, United States

Valley Clinical Trials, Inc.; 🇺🇸 Northridge, California, United States

Amicis Research Center; 🇺🇸 Granada Hills, California, United States

University of California San Diego - La Jolla; 🇺🇸 La Jolla, 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.; 🇺🇸 Safety Harbor, Florida, United States

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