Trial results for the OASIS 1 study (NCT05035095) investigating oral semaglutide tablets taken once daily for people with overweight or obesity were posted on ClinicalTrials.gov on 2026-05-07. The study showed that participants receiving oral semaglutide 50 mg achieved a mean body weight reduction of -15.8%, compared to -2.2% for those on placebo.
Background
The OASIS 1 study, also known as "Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)," aimed to evaluate the efficacy of semaglutide tablets as a treatment to help individuals living with overweight or obesity lose weight.
Trial design
The OASIS 1 study (NCT05035095) was a Phase 3, randomized, placebo-controlled trial that enrolled 667 participants. The study investigated oral semaglutide tablets in people diagnosed with obesity or who were overweight. Participants were randomly assigned to receive either oral semaglutide tablets or a placebo. The study's primary focus included evaluating the percentage change in participants' body weight.
Key results
The trial results demonstrated significant differences in weight reduction between the oral semaglutide and placebo groups. For the outcome of "Percentage Change in Body Weight":
- Participants receiving oral semaglutide 50 mg achieved a mean body weight reduction of -15.8% (Standard Deviation: 10.3).
- Participants receiving placebo achieved a mean body weight reduction of -2.2% (Standard Deviation: 7.2).
A treatment difference analysis using ANCOVA showed a difference of -12.74% (95.0% CI: -14.15 to -11.33) with a p-value of 0.0001. A Mixed Models Analysis for the hypothetical estimand also showed a treatment difference of -15.63% (95.0% CI: -17.07 to -14.18) with a p-value of 0.0001.
Regarding the proportion of participants achieving specific weight loss thresholds:
- Weight loss ≥ 5%: 269 participants in the oral semaglutide 50 mg group achieved this, compared to 76 in the placebo group.
- Weight loss ≥ 10%: 220 participants in the oral semaglutide 50 mg group achieved this, compared to 35 in the placebo group.
- Weight loss ≥ 15%: 170 participants in the oral semaglutide 50 mg group achieved this, compared to 17 in the placebo group.
Logistic regression analysis for achieving weight loss ≥ 5% showed an Odds Ratio (OR) of 12.62 (95.0% CI: 8.5 to 18.74) with a p-value of 0.0001 for the treatment policy estimand.
What this means
The results from the OASIS 1 trial indicate that oral semaglutide 50 mg significantly reduced body weight in individuals with overweight or obesity compared to placebo. The substantial mean percentage change in body weight and the higher proportion of participants achieving clinically meaningful weight loss thresholds (≥5%, ≥10%, ≥15%) suggest that oral semaglutide could be an effective therapeutic option for weight management in this population. These findings provide important data for clinicians considering treatment strategies for overweight and obesity.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05035095, titled "Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)," were posted on 2026-05-07 on clinicaltrials.gov.