Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity

What Was Tested

This registered phase 3 trial tested Semaglutide.

This study will look at how the participants daily life is affected by their heart failure.

The study will also look at the change in participants body weight from the start to the end of the study.

This is to compare the effect on heart failure symptoms and on body weight in people taking semaglutide (a new medicine) to people taking "dummy" medicine.

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

The registry classes the interventions as drug.

Who Took Part

529 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: Male or female, age above or equal to 18 years at the time of signing informed consent. Body mass index (BMI) greater than or equal to 30.0 kg/m\^2. New York Heart Association (NYHA) Class II-IV. Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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 2021-03-16 with completion listed for 2023-04-18.

It ran at 146 sites in United States (50), United Kingdom (16), Canada (14), Argentina (10), Czechia (9) and Germany (9).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) (time frame: From baseline (week 0) to end of treatment (week 52)). Change in Body Weight (time frame: From baseline (week 0) to end of treatment (week 52)).

It also tracked 13 secondary outcomes, for example Change in Six-minute Walking Distance (6MWD), The Hierarchical Composite Endpoint: Percentage of Wins of Participant Pairs, Change in C-Reactive Protein (CRP): Ratio to Baseline, Percentage of Participants Achieving 10 Percent (%) Weight Loss (Yes/No), Change in KCCQ Overall Summary Score (KCCQ-OSS) and Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in KCCQ-CSS (PGI-S).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 529 people.

With 529 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 Semaglutide compound page, all human trials.