Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity

What Was Tested

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

The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine).

Which treatment the participants get is decided by chance.

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

Participants will receive semaglutide as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.

Participants will receive placebo (semaglutide) as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.

The registry classes the interventions as drug.

Who Took Part

17604 actual participants took part.

It was open to people of any sex aged from 45 years with no upper age limit.

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

Examples of who could join: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male or female, age greater than or equal to 45 years at the time of signing informed consent. Body mass index (BMI) greater than or equal to 27 kg/m\^2.

The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: planned coronary, carotid or peripheral artery revascularisation known on the day of screening; presently classified as being in new york heart association (nyha) class iv heart failure; history of type 1 or type 2 diabetes (history of gestational diabetes is allowed).

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-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.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2018-10-24 with completion listed for 2023-06-21.

It ran at 833 sites in United States (205), Japan (49), Russia (49), United Kingdom (42), India (34) and Germany (31).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 28 secondary outcomes, for example Participants From Time of Randomisation to First Occurrence of Non-fatal MI, Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke, Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation, Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation, Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF Visit and Participants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome Measure.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 17604 people.

With 17604 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.