New indications could be on the horizon for oral semaglutide based on data from OASIS-1 and PIONEER PLUS trials. Presented at the 83rd Scientific Sessions of the American Diabetes Association (ADA 2023), a study has demonstrated that increased dosages of oral semaglutide could prove helpful not only for treating chronic weight but also for improved glycemic control. Researchers found that Patients who took 50 milligrams of Semaglutide once a day for 68 weeks saw an average weight loss of 15.1%, when they used it alongside diet and physical activity.
Researchers have assessed the efficacy and safety of the oral glucagon-like peptide-1 analogue, semaglutide 50 mg, taken once per day versus placebo for treating overweight or obesity in adults without type 2 diabetes in the trial conducted at 50 outpatient clinics in nearly nine countries.
They enrolled adults with a BMI of at least 30 kg/m2, or at least 27 kg/m2, with bodyweight-related complications and comorbidities, without type 2 diabetes.
The allocation 1:1 was done via an interactive web-response system to oral semaglutide escalated to 50 mg, or visually matching placebo, once daily for 68 weeks, plus lifestyle intervention.
Bodyweight changes and bodyweight reduction of at least 5% at week 68 for oral semaglutide 50 mg versus placebo, assessed regardless of treatment discontinuation or use of other bodyweight-lowering therapies, were the primary endpoints measured.
Researchers drew the following conclusion in their study:
- 709 participants were screened
- Three hundred thirty-four participants were assigned to oral semaglutide 50 mg and 333 to placebo.
- The estimated mean bodyweight change from baseline to week 68 was –15·1% with 50 mg oral semaglutide compared to –2·4% with placebo.
- The estimated treatment difference was reported as −12·7 percentage points.
- More participants reached bodyweight reductions of at least 5%, 10%, 15% and 20% at week 68 with oral semaglutide 50 mg versus placebo.
- Oral semaglutide 50 mg had more adverse events compared to placebo.
- Gastrointestinal adverse events (mainly mild to moderate) were reported in 268 participants with oral semaglutide 50 mg.
- In the placebo, 154 patients reported adverse events.
They interpreted studies findings as those obese adults without T2D have a significant decrease in body weight when given 50 mg once daily oral semaglutide
Novo Nordisk funded the study.
Further reading:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01185-6/fulltext
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