Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)

What Was Tested

This registered phase 3 trial tested Semaglutide.

This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight.

This study will look at the change in participants body weight.

Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body).

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 667 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 greater than or equal to 18 years at the time of signing informed consent. Body mass index (BMI):. 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 greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.

How the Study Was Run

The set-up was 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.

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 2021-09-13 with completion listed for 2023-03-24.

It ran at 56 sites in United States (13), Germany (8), Russia (8), France (7), Canada (5) and Poland (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage Change in Body Weight (time frame: Baseline (week 0), end-of-treatment (week 68)).

It also tracked 27 secondary outcomes, for example Change in Waist Circumference, Change in Body Mass Index (BMI), Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function, Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Domain, 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 667 people.

With 667 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.