ArticleDiabetes, obesity & metabolism2026
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.
Article in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
3 citing papers in PubMed.
- Semaglutide 25 mg Oral Versus Semaglutide 2.4 mg Injectable: An Indirect Treatment Comparison of Weight Loss Outcomes.Diabetes, obesity & metabolism · 2026Trial
- Positioning Incretin-Based and Next-Generation Obesity Management Medications: A Methodological Framework for a Series of Systematic Reviews and Network Meta-Analyses.Diabetes, obesity & metabolism · 2026Article
- The Impact of Missed Doses on Pharmacokinetic Concentrations for Oral Semaglutide in Comparison to Other Glucagon-Like Peptide-1-Based Therapies.Diabetes, obesity & metabolism · 2026Article
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Authors and funding
7 authors.
Funding
Abstract
aimsSemaglutide has previously been approved for weight management and cardiovascular disease as a subcutaneous formulation, and more recently also as an oral formulation. However, there is limited information across oral dose levels, and there are no studies for the 25 mg dose in people with obesity and type 2 diabetes (T2D). To fulfil health authority approval requirements, population pharmacokinetic and exposure-response analyses were used to extrapolate efficacy and safety data from subcutaneous to oral semaglutide. MATERIALS AND
methodsOnce-daily oral semaglutide 25 mg was approved for obesity treatment based on historical semaglutide data and the OASIS programme. Two studies were simulated: a modelled/virtual Phase 2 trial to establish efficacy across different oral semaglutide dose levels, and a modelled/virtual Phase 3 trial to assess efficacy in a population with overweight/obesity and T2D.
resultsMost participants (82.2%) treated with oral semaglutide 25 mg in OASIS 4 achieved exposure levels within the same range as participants treated with once-weekly subcutaneous semaglutide 2.4 mg in STEP 1. In the simulated studies, oral semaglutide 25 mg provided significantly greater weight reduction compared with placebo, for the trial product estimand and treatment policy estimand, respectively, in those with overweight/obesity and T2D (9.4% and 7.8%), and in those with overweight/obesity without T2D (16.3% and 14.7%).
conclusionsEstimated 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.
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