Study · Randomized controlled trial · n = 731 · 2025

5 results

Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity.

Packer M, Zile MR, Kramer CM, Baum SJ, Litwin SE, Menon V, Ge J, Weerakkody GJ, Ou Y, Bunck MC, Hurt KC, Murakami M, Borlaug BA

The New England journal of medicine16 Nov 2024Cited by 758 (Europe PMC)

PMID39555826DOI10.1056/nejmoa2410027PepBankPUB-39555826

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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with obesity and heart failure with preserved ejection fraction, tirzepatide lowered the risk of cardiovascular death or a worsening heart-failure event versus placebo.
In plain wordsIn adults with obesity and heart failure, tirzepatide lowered the risk of cardiovascular death or worsening heart failure compared with placebo.
Peptide
Tirzepatide
Outcome
DecreaseCardiovascular death or worsening heart-failure event
Study
n = 731
Comparator
Placebo
Analysis
Primary
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
up to 15 mg once weekly · subcutaneous · at least 52 weeksAs given in this study (human).
Measurements
hazard ratio
0.62 HR
tirzepatide vs placebo
Source sentences
Summary
Adjudicated death from cardiovascular causes or a worsening heart-failure event occurred in 36 patients (9.9%) in the tirzepatide group and in 56 patients (15.3%) in the placebo group (hazard ratio, 0.62; 95% confidence interval [CI], 0.41 to 0.95; P = 0.026).
1 context sentence(design, population, supporting numbers)
Summary · context
In this international, double-blind, randomized, placebo-controlled trial, we randomly assigned, in a 1:1 ratio, 731 patients with heart failure, an ejection fraction of at least 50%, and a body-mass index (the weight in kilograms divided by the square of the height in meters) of at least 30 to rece…
Report a problemFND-3955582601
02HumanRandomized controlled trialEfficacy outcome
In adults with obesity and heart failure with preserved ejection fraction, tirzepatide improved the KCCQ clinical summary score more than placebo at 52 weeks.
In plain wordsIn adults with obesity and heart failure, tirzepatide improved health-status scores more than placebo after 52 weeks.
Peptide
Tirzepatide
Outcome
IncreaseKCCQ-CSS change at 52 weeks
Study
n = 731
Comparator
Placebo
Analysis
Primary
Outcome group
Heart function · Cardiovascular
Studied dose
up to 15 mg once weekly · subcutaneous · at least 52 weeksAs given in this study (human).
Measurements
KCCQ-CSS change
19.5 points
tirzepatide
KCCQ-CSS change
12.7 points
placebo
between-group difference
6.9 points
tirzepatide vs placebo
Source sentences
Summary
At 52 weeks, the mean (±SD) change in the KCCQ-CSS was 19.5±1.2 in the tirzepatide group as compared with 12.7±1.3 in the placebo group (between-group difference, 6.9; 95% CI, 3.3 to 10.6; P<0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
In this international, double-blind, randomized, placebo-controlled trial, we randomly assigned, in a 1:1 ratio, 731 patients with heart failure, an ejection fraction of at least 50%, and a body-mass index (the weight in kilograms divided by the square of the height in meters) of at least 30 to rece…
Report a problemFND-3955582604
03HumanRandomized controlled trialEfficacy outcome
In adults with obesity and heart failure with preserved ejection fraction, worsening heart-failure events were less frequent with tirzepatide than with placebo.
In plain wordsIn adults with obesity and heart failure, worsening heart-failure events happened less often with tirzepatide than with placebo.
Peptide
Tirzepatide
Outcome
DecreaseWorsening heart-failure events
Study
n = 731
Comparator
Placebo
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
up to 15 mg once weekly · subcutaneous · at least 52 weeksAs given in this study (human).
Measurements
hazard ratio
0.54 HR
tirzepatide vs placebo
Source sentences
Summary
Worsening heart-failure events occurred in 29 patients (8.0%) in the tirzepatide group and in 52 patients (14.2%) in the placebo group (hazard ratio, 0.54; 95% CI, 0.34 to 0.85)
1 context sentence(design, population, supporting numbers)
Summary · context
In this international, double-blind, randomized, placebo-controlled trial, we randomly assigned, in a 1:1 ratio, 731 patients with heart failure, an ejection fraction of at least 50%, and a body-mass index (the weight in kilograms divided by the square of the height in meters) of at least 30 to rece…
Report a problemFND-3955582602
04HumanRandomized controlled trialEfficacy outcome
In adults with obesity and heart failure with preserved ejection fraction, death from cardiovascular causes did not differ significantly between tirzepatide and placebo.
In plain wordsIn adults with obesity and heart failure, deaths from cardiovascular causes did not differ clearly between tirzepatide and placebo.
Peptide
Tirzepatide
Outcome
No significant changeAdjudicated death from cardiovascular causes
Study
n = 731
Comparator
Placebo
Outcome group
Mortality · Cardiovascular
Studied dose
up to 15 mg once weekly · subcutaneous · at least 52 weeksAs given in this study (human).
Measurements
hazard ratio
1.58 HR
tirzepatide vs placebo
Source sentences
Summary
adjudicated death from cardiovascular causes occurred in 8 patients (2.2%) and 5 patients (1.4%), respectively (hazard ratio, 1.58; 95% CI, 0.52 to 4.83)
1 context sentence(design, population, supporting numbers)
Summary · context
In this international, double-blind, randomized, placebo-controlled trial, we randomly assigned, in a 1:1 ratio, 731 patients with heart failure, an ejection fraction of at least 50%, and a body-mass index (the weight in kilograms divided by the square of the height in meters) of at least 30 to rece…
Report a problemFND-3955582603
05HumanRandomized controlled trialSafety outcome
In adults with obesity and heart failure with preserved ejection fraction, adverse events (mainly gastrointestinal) led to trial-drug discontinuation more often with tirzepatide than with placebo.
In plain wordsIn adults with obesity and heart failure, more people stopped tirzepatide because of side effects than stopped placebo.
Peptide
Tirzepatide
Outcome
IncreaseAdverse events leading to discontinuation
Study
n = 731
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
up to 15 mg once weekly · subcutaneous · at least 52 weeksAs given in this study (human).
Measurements
discontinuation due to adverse events
6.3%
tirzepatide
discontinuation due to adverse events
1.4%
placebo
Source sentences
Summary
Adverse events (mainly gastrointestinal) leading to discontinuation of the trial drug occurred in 23 patients (6.3%) in the tirzepatide group and in 5 patients (1.4%) in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
In this international, double-blind, randomized, placebo-controlled trial, we randomly assigned, in a 1:1 ratio, 731 patients with heart failure, an ejection fraction of at least 50%, and a body-mass index (the weight in kilograms divided by the square of the height in meters) of at least 30 to rece…
Report a problemFND-3955582605

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
9 Oct 2026, 19:08 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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