Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide.

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

The study will also look at the change in participants' body weight.

This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms.

It had two arms (groups): one (experimental) and Semaglutide placebo OW (placebo comparator).

Participants will receive semaglutide injections for 52 weeks.

Participants will receive semaglutide placebo injections for 52 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 617 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. Diagnosed with T2D greater than or equal to 90 days prior to the day of screening.

The full record lists 6 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 quadruple-blind study.

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, care provider, investigator and outcomes assessor.

It started in 2021-06-15 with completion listed for 2023-10-11.

It ran at 180 sites in United States (54), India (19), Canada (14), Germany (10), Hungary (10) and United Kingdom (10).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score (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 21 secondary outcomes, for example Change in 6-minute walking distance, Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit, Hierarchical composite of time to first heart failure event requiring hospitalisation or urgent heart failure visit, Hierarchical composite of difference at least 10 in KCCQ clinical summary score change from baseline to 52 weeks, Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks and Change in C-Reactive Protein.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 617 people.

With 617 participants it is a large trial for this field.

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.