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

What Was Tested

The trial (phase 3) is built around Tirzepatide.

It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).

Participants received placebo administered SC QW.

The registry classes the interventions as drug and other.

More on the Plan

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.

Who Took Part

Enrollment: 731 actual participants took part.

It was open to people of any sex aged from 40 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: have had a major cardiovascular event within the last 90 days of screening; have had acute decompensated heart failure within 4 weeks of screening; presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular heart disease.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant and investigator.

It started in 2021-04-20 with completion listed for 2024-07-02.

It ran at 146 sites in United States (54), China (21), Argentina (17), Brazil (11), Israel (11) and India (10).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) (time frame: Baseline, Week 52). First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes (time frame: Baseline Up To 160 weeks).

It also tracked 9 secondary outcomes, for example Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD), Percent Change From Baseline in Body Weight, Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP), Win Percentage of the Hierarchical Composite Endpoint, Percentage of Participants With New York Heart Association (NYHA) Class Change and Number of Participants With Time to First Occurrence of HF Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 731 people.

With 731 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Tirzepatide compound page, all human trials.