Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

What Was Tested

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

This study will look at the change in body weight from the start to the end of the study.

Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine.

In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 304 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Male or female, age more than or equal to 18 years at the time of signing informed consent. History of at least one self-reported unsuccessful dietary effort to lose body weight.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: A self-reported change in body weight more 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.

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.

The Semaglutide group and the comparison group ran side by side rather than switching.

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 2018-10-05 with completion listed for 2021-01-29.

It ran at 41 sites in United States (15), Canada (9), Hungary (6), Spain (6) and Italy (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage Change From Baseline (Week 0) to Week 104 in Body Weight (time frame: From Baseline (Week 0) to Week 104).

It also tracked 35 secondary outcomes, for example Change From Baseline (Week 0) to Week 104 in Waist Circumference, Change From Baseline (Week 0) to Week 104 in Body Weight (kg), Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI), Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure, Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure and Change in Total Cholesterol-ratio to Baseline.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 304 people.

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.