Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction

What Was Tested

This registered phase 4 trial tested Semaglutide.

It had two arms (groups): Semaglutide Treatment (active comparator) and Placebo Treatment (placebo comparator).

Subjects will receive Semaglutide once weekly in addition to counselling on healthy lifestyle intervention.

Subjects will receive matching placebo once weekly in addition to counselling on healthy lifestyle intervention.

The registry classes the interventions as behavioral and drug.

Who Took Part

Enrollment: 81 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: BMI ≥ 30.0 kg/m2. NYHA Class II-IV. No hospitalizations due to heart failure in the preceding 30 days. At least one of the following:.

The full record lists 8 inclusion and 22 exclusion criteria; among the exclusions: myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening; systolic blood pressure \> 160 mmhg at screening; planned coronary, carotid or peripheral artery revascularization.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2022-09-06 with completion listed for 2026-07-17.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Pulmonary Capillary Wedge Pressure (PCWP) (time frame: Baseline, 12 months).

It also tracked 28 secondary outcomes, for example Trans-cardiac uptake of free fatty acids (FFA) at rest, Trans-cardiac uptake of free fatty acids (FFA) during exercise, Trans-cardiac uptake of glucose at rest, Trans-cardiac uptake of glucose during exercise, Trans-cardiac uptake of ketone bodies at rest and Trans-cardiac uptake of ketone bodies during exercise.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 81 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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