OASIS 2: oral semaglutide 50 mg in East Asian adults

Why this study matters

People of East Asian background tend to develop weight-related health conditions at lower BMI levels than other groups, so trials in this population use different entry rules. OASIS 2 tested the daily 50 mg semaglutide (Wegovy, Ozempic) tablet in adults in Japan and South Korea, and unlike OASIS 1 it included some people with type 2 diabetes. For Canadian readers of East Asian background, or anyone interested in an oral form, it fills a gap. The tablet regimen here is a research description, not a statement about availability in Canada.

Who was in the study

OASIS 2 enrolled 201 adults at sites in Japan and South Korea between November 2021 and September 2023. To join, a person needed a BMI of 27.0 or higher with two or more weight-related health conditions, or a BMI of 35.0 or higher with one or more. BMI (body mass index) compares weight with height. The plan was for about a quarter of participants to have type 2 diabetes; in the end, 51 people (25.4%) did.

The mean age was 49 years and mean body weight was 91.9 kg. Eighty-seven participants (43.3%) were female. In total, 134 people were assigned to oral semaglutide and 67 to placebo. Treatment lasted 68 weeks, followed by 7 weeks of follow-up.

What the researchers did

This was a multicentre, double-blind, placebo-controlled, phase 3a randomized trial. Randomized means chance decided the treatment, in a 2:1 ratio. Double-blind means neither participants nor staff knew who was on the medicine. Placebo means an inactive tablet that looked the same.

People took oral semaglutide 50 mg or placebo once a day for 68 weeks, plus lifestyle recommendations. The two main outcomes were percentage change in body weight and the share of people who lost at least 5% of their starting weight. Changes in physical function, cardiometabolic risk factors and safety were also measured. How missing data were handled was not extracted.

What they found

The mean percentage change in body weight was -14.3% with oral semaglutide and -1.3% with placebo (R32-C21). The estimated treatment difference was -13.07 percentage points, with a 95% confidence interval of -15.61 to -10.52. A confidence interval is the range where the true difference most likely lies. The result was very unlikely to be chance (P less than 0.001).

The odds ratio for losing at least 5% was 23.00 (95% CI 10.28 to 51.42), meaning this outcome was far more likely with the medicine. The summary we reviewed does not report results separately for people with and without diabetes, or the changes in physical function or risk factors.

Side effects and people who stopped

Stomach and gut side effects were reported by 85 of 134 people (63.4%) on oral semaglutide and 23 of 66 (34.8%) on placebo. Adverse events led to treatment discontinuation in 6 of 134 people (4.5%) on semaglutide (R32-C22). The corresponding figure for placebo was not reported in the summary we reviewed. The authors described the safety profile as consistent with this class of medicines.

What this study does not tell you

• With 201 people from two countries, the trial was small and regional. It does not show how the tablet performs in other populations.
• People with and without type 2 diabetes were combined in the main result. Separate results were not in the summary we reviewed.
• The tablet was compared with placebo, not with the injectable form, so the two cannot be ranked from this trial.
• Both groups had lifestyle support.
• It measured weight over 68 weeks, not heart or other health events, and not what happens after stopping.
• The summary we reviewed does not state the funding source. Our data extraction relied on the abstract only, because the full text could not be retrieved.

What it means in Canada

OASIS 2 shows what a daily 50 mg semaglutide tablet did in East Asian adults in a research setting. This page does not state whether an oral form is approved or covered for weight management in Canada. See semaglutide in Canada and public drug coverage by province.

Related reading

Other studies in this library that bear on the same question.

Source