Study · Randomized controlled trial · n = 731 · 2025

8 results

Effects of Tirzepatide on the Clinical Trajectory of Patients With Heart Failure, Preserved Ejection Fraction, and Obesity.

Zile MR, Borlaug BA, Kramer CM, Baum SJ, Litwin SE, Menon V, Ou Y, Weerakkody GJ, Hurt KC, Kanu C, Murakami M, Packer M

Circulation18 Nov 2024Cited by 58 (Europe PMC)

PMID39556714PMCIDPMC11893002DOI10.1161/circulationaha.124.072679PepBankPUB-39556714

Read at source PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with heart failure with preserved ejection fraction and obesity, tirzepatide increased the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score by 6.9 points versus placebo at 52 weeks.
In plain wordsIn adults with heart failure and obesity, tirzepatide improved the heart failure health score more than placebo at 52 weeks.
Peptide
Tirzepatide
Outcome
IncreaseKansas City Cardiomyopathy Questionnaire Clinical Summary Score at 52 weeks
Study
n = 731
Comparator
Placebo
Analysis
Primary
Outcome group
Quality of life · Cardiovascular
Studied dose
titrated up to 15 mg weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
KCCQ-CSS change
6.9 points
52 weeks
Source sentences
Summary
At 52 weeks, tirzepatide increased the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score by 6.9 points (95% CI, 3.3-10.6; P<0.001)
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized (double-blind) 731 patients with class II to IV heart failure, ejection fraction ≥50%, and body mass index ≥30 kg/m² to tirzepatide (titrated up to 15 mg SC weekly; n=364) or placebo (n=367) added to background therapy for a median of 104 weeks (quartile 1, 66; quartile 3, 126 weeks).
Report a problemFND-3955671402
02HumanRandomized controlled trialEfficacy outcome
In adults with heart failure with preserved ejection fraction and obesity, tirzepatide gave a consistent benefit across composites of death and worsening heart failure events versus placebo.
In plain wordsIn adults with heart failure and obesity, tirzepatide lowered the risk of death or worsening heart failure more than placebo.
Peptide
Tirzepatide
Outcome
DecreaseComposites of death and worsening heart failure, time to first event
Study
n = 731
Comparator
Placebo
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
titrated up to 15 mg weekly · subcutaneous · median of 104 weeksAs given in this study (human).
Measurements
Hazard ratio
0.41 to 0.67 ratio
composites of death and worsening heart failure
Source sentences
Summary
Compared with placebo, tirzepatide produced a consistent beneficial effect across all composites of death and worsening heart failure events, analyzed as time to first event (hazard ratios, 0.41-0.67).
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized (double-blind) 731 patients with class II to IV heart failure, ejection fraction ≥50%, and body mass index ≥30 kg/m² to tirzepatide (titrated up to 15 mg SC weekly; n=364) or placebo (n=367) added to background therapy for a median of 104 weeks (quartile 1, 66; quartile 3, 126 weeks).
Report a problemFND-3955671401
03HumanRandomized controlled trialEfficacy outcome
In adults with heart failure with preserved ejection fraction and obesity, tirzepatide increased 6-minute walk distance by 18.3 meters versus placebo at 52 weeks.
In plain wordsIn adults with heart failure and obesity, tirzepatide increased how far they could walk in 6 minutes more than placebo at 52 weeks.
Peptide
Tirzepatide
Outcome
Increase6-minute walk distance at 52 weeks
Study
n = 731
Comparator
Placebo
Outcome group
Exercise and physical function · Cardiovascular
Studied dose
titrated up to 15 mg weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
6-minute walk distance change
18.3 m
52 weeks
Source sentences
Summary
6-minute walk distance 18.3 meters (95% CI, 9.9-26.7; P<0.001)
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized (double-blind) 731 patients with class II to IV heart failure, ejection fraction ≥50%, and body mass index ≥30 kg/m² to tirzepatide (titrated up to 15 mg SC weekly; n=364) or placebo (n=367) added to background therapy for a median of 104 weeks (quartile 1, 66; quartile 3, 126 weeks).
Report a problemFND-3955671403
04HumanRandomized controlled trialEfficacy outcome
In adults with heart failure with preserved ejection fraction and obesity, tirzepatide increased the EQ-5D-5L index by 0.06 versus placebo at 52 weeks.
In plain wordsIn adults with heart failure and obesity, tirzepatide improved the self-rated health score more than placebo at 52 weeks.
Peptide
Tirzepatide
Outcome
IncreaseEQ-5D-5L health state index at 52 weeks
Study
n = 731
Comparator
Placebo
Outcome group
Quality of life · Cardiovascular
Studied dose
titrated up to 15 mg weekly · subcutaneous · 52 weeksAs given in this study (human).
Measurements
EQ-5D-5L change
0.06 index points
52 weeks
Source sentences
Summary
At 52 weeks, tirzepatide increased the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score by 6.9 points (95% CI, 3.3-10.6; PPP<0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized (double-blind) 731 patients with class II to IV heart failure, ejection fraction ≥50%, and body mass index ≥30 kg/m² to tirzepatide (titrated up to 15 mg SC weekly; n=364) or placebo (n=367) added to background therapy for a median of 104 weeks (quartile 1, 66; quartile 3, 126 weeks).
Report a problemFND-3955671404
05HumanRandomized controlled trialEfficacy outcome
In adults with heart failure with preserved ejection fraction and obesity, the tirzepatide group shifted to a more favorable Patient Global Impression of Severity Overall Health score than placebo.
In plain wordsIn adults with heart failure and obesity, patients on tirzepatide rated their overall health as better than patients on placebo.
Peptide
Tirzepatide
Outcome
Not applicablePatient Global Impression of Severity Overall Health score
Study
n = 731
Comparator
Placebo
Outcome group
Quality of life · Cardiovascular
Studied dose
titrated up to 15 mg weekly · subcutaneous · median of 104 weeksAs given in this study (human).
Measurements
Proportional odds ratio
1.99 ratio
PGIS Overall Health
Source sentences
Summary
The tirzepatide group shifted to a more favorable Patient Global Impression of Severity Overall Health score (proportional odds ratio, 1.99 [95% CI, 1.44-2.76]) and New York Heart Association class (proportional odds ratio, 2.26 [95% CI, 1.54-3.31]; both P<0.001) and required fewer heart fail…
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized (double-blind) 731 patients with class II to IV heart failure, ejection fraction ≥50%, and body mass index ≥30 kg/m² to tirzepatide (titrated up to 15 mg SC weekly; n=364) or placebo (n=367) added to background therapy for a median of 104 weeks (quartile 1, 66; quartile 3, 126 weeks).
Report a problemFND-3955671405
06HumanRandomized controlled trialEfficacy outcome
In adults with heart failure with preserved ejection fraction and obesity, the tirzepatide group shifted to a more favorable New York Heart Association class than placebo.
In plain wordsIn adults with heart failure and obesity, patients on tirzepatide moved to milder heart failure classes more than patients on placebo.
Peptide
Tirzepatide
Outcome
Not applicableNew York Heart Association class
Study
n = 731
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
titrated up to 15 mg weekly · subcutaneous · median of 104 weeksAs given in this study (human).
Measurements
Proportional odds ratio
2.26 ratio
NYHA class
Source sentences
Summary
The tirzepatide group shifted to a more favorable Patient Global Impression of Severity Overall Health score (proportional odds ratio, 1.99 [95% CI, 1.44-2.76]) and New York Heart Association class (proportional odds ratio, 2.26 [95% CI, 1.54-3.31]; both P<0.001) and required fewer heart fail…
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized (double-blind) 731 patients with class II to IV heart failure, ejection fraction ≥50%, and body mass index ≥30 kg/m² to tirzepatide (titrated up to 15 mg SC weekly; n=364) or placebo (n=367) added to background therapy for a median of 104 weeks (quartile 1, 66; quartile 3, 126 weeks).
Report a problemFND-3955671406
07HumanRandomized controlled trialEfficacy outcome
In adults with heart failure with preserved ejection fraction and obesity, tirzepatide patients required fewer heart failure medications than placebo patients.
In plain wordsIn adults with heart failure and obesity, patients on tirzepatide needed fewer heart failure medicines than patients on placebo.
Peptide
Tirzepatide
Outcome
DecreaseUse of heart failure medications
Study
n = 731
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
titrated up to 15 mg weekly · subcutaneous · median of 104 weeksAs given in this study (human).
Source sentences
Summary
The tirzepatide group shifted to a more favorable Patient Global Impression of Severity Overall Health score (proportional odds ratio, 1.99 [95% CI, 1.44-2.76]) and New York Heart Association class (proportional odds ratio, 2.26 [95% CI, 1.54-3.31]; both P<0.001) and required fewer heart fail…
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized (double-blind) 731 patients with class II to IV heart failure, ejection fraction ≥50%, and body mass index ≥30 kg/m² to tirzepatide (titrated up to 15 mg SC weekly; n=364) or placebo (n=367) added to background therapy for a median of 104 weeks (quartile 1, 66; quartile 3, 126 weeks).
Report a problemFND-3955671407
08HumanRandomized controlled trialEfficacy outcome
In adults with heart failure with preserved ejection fraction and obesity, tirzepatide gave a benefit on the hierarchical composite versus placebo (win ratio 1.63).
In plain wordsIn adults with heart failure and obesity, tirzepatide did better than placebo on a combined measure of death, hospital events, symptoms and walking.
Peptide
Tirzepatide
Outcome
Not applicableHierarchical composite of death, worsening heart failure, KCCQ-CSS and 6-minute walk distance
Study
n = 731
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
titrated up to 15 mg weekly · subcutaneous · median of 104 weeksAs given in this study (human).
Measurements
Win ratio
1.63 ratio
hierarchical composite
Source sentences
Summary
The broad spectrum of effects was reflected in benefits on the hierarchical composite (win ratio, 1.63 [95% CI, 1.17-2.28]; P=0.004).
1 context sentence(design, population, supporting numbers)
Summary · context
We randomized (double-blind) 731 patients with class II to IV heart failure, ejection fraction ≥50%, and body mass index ≥30 kg/m² to tirzepatide (titrated up to 15 mg SC weekly; n=364) or placebo (n=367) added to background therapy for a median of 104 weeks (quartile 1, 66; quartile 3, 126 weeks).
Report a problemFND-3955671408

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 1 not yet recruiting · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Not yet recruitingPhase 3NCT07738276

Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity

Shahid Beheshti University of Medical Sciencesn = 60est. 18 Jul 2026 to est. 22 Dec 2027

Heart Failure and Reduced Ejection Fraction · Obesity & Overweight · Tirzepatide

Trial page ClinicalTrials.govUpdated 3 Aug 2026

CompletedPhase 3Results postedNCT04847557

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

Eli Lilly and Companyn = 73120 Apr 2021 to 2 Jul 2024

Obesity · Heart Failure With Preserved Ejection Fraction (HFpEF)

Trial page ClinicalTrials.govUpdated 20 Aug 2025

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
12 Oct 2026, 12:58 UTC
Study results updated
Version 1
9 Oct 2026, 03:07 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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