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Cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the groundbreaking news of oral semaglutide's approval and its cardioprotective benefits.
Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!
In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, provide an in-depth discussion of the FDA approval of oral semaglutide (oral Wegovy) for chronic weight management, with market availability anticipated as early as January 2026. The conversation centers on the clinical, regulatory, and practical implications of introducing the first oral GLP-1 receptor agonist approved specifically for weight loss, long-term weight maintenance, and cardiovascular risk reduction.
00:00:01 Intro
00:00:12 Oral Wegovy is now FDA approved
00:02:16 Cardiovascular reduction from an oral GLP-1?
00:04:55 Oral versus injectable weight loss medications
00:05:21 Specific instructions for taking oral GLP-1s
00:10:10 Uptake of oral semaglutide
00:12:12 Orforglipron versus semaglutide
00:13:37 Outro
The hosts review the evidence underpinning approval, focusing on phase 3 data from the OASIS program, including OASIS 4, which enrolled more than 300 participants, and supporting trials encompassing over 17,000 patients. Oral semaglutide, titrated up to 25 mg once daily, produced up to 14% mean weight loss at 64 weeks compared with approximately 2% with placebo – this demonstrated durable, long-term efficacy rather than short-term weight reduction. Isaacs and Bellini highlight the importance of the extended follow-up period and the consistency of weight loss outcomes, particularly given longstanding concerns about sustainability with obesity pharmacotherapy.
The discussion then shifts to the cardiovascular indication recently granted to oral semaglutide. The hosts explain that cardiovascular outcomes were not directly studied at the 25-mg oral dose in a dedicated outcomes trial. Instead, the FDA accepted extrapolation from the SELECT trial, in which injectable semaglutide 2.4 mg weekly demonstrated a 20% reduction in major adverse cardiovascular events, along with prior cardiovascular outcomes data from oral semaglutide in type 2 diabetes. Isaacs underscores the significance of this regulatory decision, noting that it avoids redundant, costly trials and accelerates patient access to therapies with well-established class effects.
The episode also addresses real-world considerations that will influence uptake. The anticipated lower cash price – reported at approximately $149 – could substantially improve access, particularly compared with injectable GLP-1–based weight loss therapies. The hosts discuss patient preferences, noting that an oral option may appeal to individuals hesitant about injections and may offer a greater sense of control despite similar pharmacokinetics and side-effect profiles.
At the same time, Isaacs and Bellini stress the critical role of patient education. Oral semaglutide requires strict administration conditions, including ingestion with limited water and no food or beverages for at least 30 minutes, as well as careful dose titration. Pills cannot be split or doubled, and improper use may significantly reduce absorption and efficacy. The episode concludes with a forward-looking discussion of payer dynamics, step-therapy considerations, and emerging oral GLP-1 agents, positioning oral semaglutide as a potentially transformative addition to obesity and cardiovascular risk management in clinical practice.
