Novo Nordisk’s Wegovy approved for patients with obesity and clinical study showed people lost about 21% of their body weight on average

The EC has now approved their new 7.2 mg once‑weekly maintenance dose of Wegovy for adults living with obesity. This gives doctors another option to help adults who need more weight loss after being on the 2.4 mg dose. This approval means that doctors in the EU may now prescribe the 7.2 mg dosage as three 2.4 mg injections, to be taken in one sitting, still once a week. Novo Nordisk has applied for approval of a 7.2 mg single-dose pen in the EU, and if approved, it could be available this year. This means that in the EU, adults with obesity may now step directly from Wegovy2.4 mg up to 7.2 mg if they need greater weight loss while preserving muscle function.

Note that Wegovy 7.2 mg was already approved and available in the UK, and regulatory applications are pending with the US FDA and several other countries.

What did the study show?
In the two clinical studies, STEP UP and STEP UP T2D adults with obesity, without and with type 2 diabetes, respectively, who took the 7.2 mg dose once a week, plus lifestyle changes, lost considerably more weight than people on placebo.

  • 21% body weight loss for those on Wegovy® 7.2 mg when everyone took the medicine as planned, compared to about 2% weight loss for those taking placebo.
  • About 1 in 3 people lost 25% or more of their body weight.
  • Body composition improved with the majority (84%) of weight loss with Wegovy® 7.2 mg coming from fat mass, with tests showing preserved muscle functioning.
  • The most common side effects were nausea, diarrhoea, vomiting (24.8%) and dysaesthesia (22-9%). These events were usually mild to moderate and transient.

 



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