A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight

What Was Tested

This registered phase 3 trial tested Semaglutide.

This study will look at how much weight participants will lose and how much blood sugar control they achieve 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: 512 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. BMI greater than or equal to 30.0 kilograms per square meter (kg/m\^2). Diagnosed with type 2 diabetes (T2D) greater than or equal to 180 days prior to the day of screening. History of at least one self-reported unsuccessful dietary effort to lose body weight.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds \[lbs\]) within 90 days before screening irrespective of medical records; personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

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 2023-01-04 with completion listed for 2024-10-28.

It ran at 76 sites in United States (23), South Africa (11), Bulgaria (9), Poland (8), Hungary (7) and Canada (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Relative Change in Body Weight (time frame: Baseline (week 0), End of treatment (week 72)).

It also tracked 34 secondary outcomes, for example Change in Waist Circumference, Change in Glycated Haemoglobin (HbA1c), Change in Body Weight, Change in Body Mass Index (BMI), Change in Systolic Blood Pressure and Change in Diastolic Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 512 people.

With 512 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.