ClinicalTrials.gov posted results on 2026-08-10 for NCT05035082, a completed phase 4 study of semaglutide in adults with type 2 diabetes. In the REALYSE trial, oral semaglutide lowered HbA1c by -1.20 percentage points versus -0.99 with other oral glucose-lowering medications.
Background
The study evaluated oral semaglutide (RYBELSUS®) against other commercially available oral glucose-lowering medications in people living in America with type 2 diabetes. The posted record says the trial looked at treatment used in addition to metformin.
Trial design
REALYSE was a completed study with 1,018 participants. The record compared oral semaglutide with oral glucose-lowering medications (commercially available) and reported outcomes related to HbA1c change and achievement of prespecified HbA1c targets.
Key results
For change in glycated haemoglobin, the mean change was -1.20 with 1.463 standard deviation in the oral semaglutide group and -0.99 with 1.516 standard deviation in the other oral glucose-lowering medication group. The primary estimand analysis used ANCOVA and found a treatment difference of -0.24 percentage points, with a 95.0% confidence interval of -0.44 to -0.04 and a p value of 0.018.
More participants on oral semaglutide achieved an HbA1c of <7.0% or at least a 1.0%-point reduction: 239 versus 180. The record also lists target-based responder counts for HbA1c thresholds including <7.0% and ≤6.5%.
What this means
These posted results add phase 4 evidence that oral semaglutide produced a larger average HbA1c reduction than other oral diabetes tablets in this completed trial. For clinicians and researchers, the data support semaglutide's role as an oral option for glucose lowering in type 2 diabetes, while the posted record should be used alongside full trial details when interpreting the responder analyses.
Source
This information is based on ClinicalTrials.gov results for NCT05035082 posted on 2026-08-10. The record is available at clinicaltrials.gov.