The US Food and Drug Administration has approved semaglutide 7.2 mg (Wegovy HD), based on results from the phase 3 STEP UP clinical trial program in adults with obesity, including a trial in adults with obesity and type 2 diabetes, according to a press release from Novo Nordisk.

The FDA also granted a Commissioner’s National Priority Voucher for Wegovy HD, accelerating its review and underscoring its potential to address national health priorities in the United States. Semaglutide 7.2 mg is a once-weekly injectable therapy indicated to reduce excess body weight and maintain long-term weight reduction.

In the 72-week STEP UP trial of approximately 1,400 adults with obesity receiving lifestyle intervention, semaglutide 7.2 mg demonstrated a mean weight loss of 20.7%, with 31.2% of patients achieving reductions of at least 25%.

In the 72-week STEP UP T2D trial of approximately 500 adults with obesity and type 2 diabetes, mean weight loss was 14.1%, and 21.3% of patients achieved reductions of at least 20%.

Across both trials, the safety and tolerability profile of semaglutide 7.2 mg was consistent with previous semaglutide studies for weight management.

Wegovy is approved in once-weekly injectable formulations (1.7 mg, 2.4 mg, and 7.2 mg) as well as an oral formulation. It is also approved by the FDA to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight, to reduce excess body weight and maintain long-term weight reduction in adults and pediatric patients aged 12 years and older, and for the treatment of metabolic dysfunction–associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (excluding cirrhosis).

Novo Nordisk expects to launch semaglutide 7.2 mg in a single-dose pen in the US in April 2026.

Source: Novo Nordisk