Oral semaglutide and cardiovascular (CV) benefits in the SOUL trial: how do baseline or changes in HbA1c and BMI affect clinical outcomes?
Authors' conclusion
In SOUL, CV benefits of oral semaglutide appeared more pronounced among participants with higher baseline HbA1c and greater HbA1c reductions, but were consistent across baseline or changes in BMI.
Study context
- Population
- Adults aged ≥50 years with T2D and atherosclerotic CVD and/or CKD; median age 66 years, mean HbA1c 8.0%, mean BMI 31.1 kg/m²randomized 1:1
- Participants
- 9,650 adults
- Comparison
- Oral semaglutide vs placebo
- Primary endpoint
- 3-point MACE (CV death, nonfatal MI or nonfatal stroke) by baseline and in-trial changes in HbA1c and BMI
- Follow-up
- Weeks 13; 52
Methodological detailspost hoc analysis, double-blind, placebo-controlled, international, 444 sites
- Post hoc analysis
- Double-blind
- Placebo-controlled
- International
- 444 sites
Primary result
As reported in the abstract
MACE benefit of oral semaglutide by baseline and in-trial change in HbA1c and BMI · followed for 47.5 months
- Greater MACE risk reduction at higher baseline HbA1c
- MACE benefit consistent across baseline BMI categories
- Greater in-trial HbA1c reductions associated with larger decreases in MACE risk with oral semaglutide at 13 and 52 weeks
- MACE benefit consistent across in-trial BMI changes
- Oral semaglutide vs Placebo: P for interaction = 0.04
- Oral semaglutide vs Placebo: P-interaction .005
- Oral semaglutide vs Placebo: P for interaction < 0.001
- Oral semaglutide vs Placebo: P-interaction .88
- Oral semaglutide vs Placebo: P-interaction .64
- Post hoc analysis
Original publication
Oral semaglutide and CV benefits in the SOUL trial: how do baseline or changes in HbA1c and BMI affect clinical outcomes? J Clin Endocrinol Metab. Published 21 July 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →