Loading clinical trials...

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

COMPLETEDPHASE3

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

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)

NCT04847557•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (146)

Heart Center Research

Huntsville, Alabama, United States

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

Key Dates

Start Date

April 20, 2021

Primary Completion Date

July 2, 2024

Completion Date

July 2, 2024

Last Updated

August 20, 2025

Enrollment

731

ACTUAL participants

Conditions

ObesityHeart Failure With Preserved Ejection Fraction (HFpEF)

Interventions

Tirzepatide

DRUG

Placebo

OTHER

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

NCT07472881

MenopausePerimenopause+2 more

View study

RECRUITING

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

Metabolic DiseaseObesity+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial

Protein Supplementation Intervention on Body Weight

Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss