- Wegovy HD, a higher-dose semaglutide, got FDA approval for obesity treatment
- Clinical trials showed an average weight loss of 20.7% with the 7.2 mg dose
- Novo Nordisk plans to launch Wegovy HD in the US in April 2026
Wegovy HD, a higher-dose version from Danish drugmaker Novo Nordisk, has received approval from the US Food and Drug Administration with clinical trials showing an average weight loss of 20.7 per cent.
Novo Nordisk said it plans to launch the new formulation, (semaglutide 7.2 mg), in the United States in April 2026. The once-weekly injection aimed at helping people with obesity lose weight and keep it off over the long term.
Nearly one in three patients lost at least 25 per cent of their body weight in clinical trials.
The approval is based on two 72-week late-stage studies-STEP UP and STEP UP T2D-which together evaluated nearly 2,000 participants, where patients on the higher dose lost about one-fifth of their body weight on average.
In the main STEP UP trial, involving around 1,400 adults with obesity, the higher dose was tested against the currently used 2.4 mg dose and a placebo, alongside lifestyle changes such as diet and exercise.
Patients who remained on treatment recorded an average weight loss of 20.7 per cent, while the overall reduction, including those who did not fully adhere to treatment, was 18.7 per cent.
In the STEP UP T2D trial, which included about 500 adults with both obesity and type 2 diabetes, the average weight loss was lower at 14.1 per cent. Even so, over 21 per cent of participants in this group lost at least 20 per cent of their body weight.
Both trials found that the safety and tolerability of the higher dose were consistent with earlier versions of semaglutide, with no major new concerns flagged.
The company said the safety profile of the higher dose remained consistent with earlier versions of the drug, meaning no major new side effects were observed compared to existing treatments.
The drug has been cleared under the FDA's Commissioner's National Priority Voucher programme, a fast-track review pathway meant for treatments addressing critical public health needs, underscoring the growing focus on obesity.
Wegovy is already available in lower doses, including a 2.4 mg version, and is also approved to reduce the risk of serious heart-related conditions such as heart attacks and strokes in certain patients.
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