Higher dosage of oral semaglutide useful for chronic weight management and glycemic control

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