A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)

What Was Tested

This registered phase 3 trial tested Semaglutide.

This study will look at how much weight participants will lose from the start to the end of the study.

In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1407 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 kilogram per square meter (kg/m\^2). History of at least one self-reported unsuccessful dietary effort to lose body weight.

How the Study Was Run

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

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide 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 Semaglutide.

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

It started in 2023-01-04 with completion listed for 2024-10-30.

It ran at 107 sites in United States (21), Bulgaria (10), Germany (10), South Africa (10), Greece (9) and Canada (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Semaglutide [amount hidden] Versus Placebo: Relative Change in Body Weight.

It also tracked 44 secondary outcomes, for example Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (%), Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (Liters), Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (%), Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (Liters), Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (%) and Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (Liters).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 1407 people.

With 1407 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.