Regulatory

Wegovy becomes the first GLP-1 pill approved for weight management

The FDA approved oral semaglutide 25 mg once daily to reduce excess body weight, maintain weight reduction and lower the risk of major cardiovascular events. In OASIS 4, participants lost a mean 16.6% of body weight at 64 weeks on treatment versus 2.7% on placebo.

EVIDENCE

Regulatory decision

WHY IT MATTERS

Injection-level results now come in a pill. It must be taken on an empty stomach with a small sip of water and a 30-minute wait before eating or drinking.

The details

OASIS 4 randomized 307 adults with obesity, or overweight with at least one weight-related condition. About one in three lost at least 20% of body weight, and side effects mirrored injectable semaglutide, led by nausea, vomiting and constipation.

PRIMARY SOURCE

Novo Nordisk release, December 22, 2025; Wharton et al., N Engl J Med 2025

OASIS 4 · NCT05564117

Educational summary only. It is not medical advice and does not replace a conversation with your clinician.