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05-06-2021 | Semaglutide | News

approvalsWatch

FDA approves higher semaglutide dose for obesity

Author:
Eleanor McDermid

medwireNews: The US FDA has approved the 2.4 mg weekly dose of semaglutide to treat obesity regardless of the presence of type 2 diabetes.

The dose is higher than the 1.0 mg weekly dose currently approved for reducing blood glucose levels in people with type 2 diabetes. The STEP 2 trial showed that the higher dose produces only a slight additional improvement in glycemic control, but a markedly larger reduction in bodyweight.

STEP 2 was the only trial in the STEP series to recruit people with diabetes; the others all enrolled people who had a BMI of 30 kg/m2 or of 25 kg/m2 with related comorbidities, but not diabetes. Four of these trials have published to date, with four still in progress.

The cardiovascular safety/efficacy study for semaglutide 2.4 mg/week, SELECT, is ongoing, with results expected in the second half of 2023.

The FDA notes that semaglutide 2.4 mg should not be used in combination with other glucagon-like peptide-1 receptor agonists, or with other products intended for weight loss, including prescription drugs, over-the-counter drugs, or herbal products.”

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group

Semaglutide for weight loss: The STEP and SELECT trials

Get the latest results and insights from the researchers.

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