Efficacy, Safety and PK of Once‐Daily Oral Semaglutide 25 mg for Obesity With and Without Type 2 Diabetes in Comparison With Subcutaneous Semaglutide 2.4 mg: A Model‐Informed Drug Development Approach
Authors' conclusion
Estimated exposure levels and efficacy observed with oral semaglutide 25 mg were similar to those obtained with subcutaneous semaglutide 2.4 mg, supporting application of oral semaglutide 25 mg to treat individuals with overweight/obesity, with/without T2D.
Study context
- Population
- People with overweight/obesity with and without T2D (simulated; OASIS 4 and STEP 1 data)
- Comparison
- Once-daily oral semaglutide 25 mg vs placebo; exposure vs once-weekly subcutaneous semaglutide 2.4 mg
- Outcome
- Weight reduction vs placebo in simulated studies (trial product estimand and treatment policy estimand, respectively)
Methodological detailspopulation pharmacokinetic and exposure-response analyses, model-informed drug development, simulated virtual Phase 2 and Phase 3 trials
- Population pharmacokinetic and exposure-response analyses
- Model-informed drug development
- Simulated virtual Phase 2 and Phase 3 trials
Main finding
As reported in the abstract
Overweight/obesity and T2D: significantly greater weight reduction with oral semaglutide 25 mg vs placebo (trial product estimand and treatment policy estimand)
9.4% and 7.8%
Overweight/obesity without T2D: significantly greater weight reduction with oral semaglutide 25 mg vs placebo (trial product estimand and treatment policy estimand)
16.3% and 14.7%
Further findings
- Exposure within the same range as subcutaneous semaglutide 2.4 mg in STEP 1 — Oral semaglutide 25 mg
- 82.2%
- Exposure within the same range as subcutaneous semaglutide 2.4 mg in STEP 1: OASIS 4 participants
Original publication
Efficacy, Safety and PK of Once‐Daily Oral Semaglutide 25 mg for Obesity With and Without Type 2 Diabetes in Comparison With Subcutaneous Semaglutide 2.4 mg: A Model‐Informed Drug Development Approach. Diabetes Obes Metab. Published 23 April 2026. doi:10.
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