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News about a drug that has been called a "game changer" for the medical management of obesity resulted in this week's top trending clinical topic. In early June, the US Food and Drug Administration (FDA) approved a 2.4-mg/week subcutaneous dose of the glucagonlike peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy) for weight loss. Specifically, the drug format and dosage was approved as an adjunct to lifestyle modifications in adults with obesity (body mass index ≥ 30 kg/m2) or who are overweight (≥ 27 kg/m2) with at least one weight-related comorbidity.
According to a statement from Novo Nordisk, semaglutide "induces weight loss by reducing hunger, increasing feelings of fullness, and thereby helping people eat less." The medication is currently under review by the European Medicines Agency. The FDA approval was based on results from the Semaglutide Treatment Effect in People With Obesity (STEP) program of four phase 3 clinical trials. In the STEP 1, 2, and 4 trials, those in the semaglutide groups attained a 15%-18% weight loss over 68 weeks. STEP 4 — an international, multicenter trial — found that weekly injections helped patients maintain, and even increase, their initial weight loss on the agent when they continued treatment beyond 20 weeks.
The drug "is likely to usher in a new era in the medical treatment of obesity," stated Lee M. Kaplan, MD, PhD, at the virtual American Diabetes Association 81st Scientific Sessions. Other experts are equally optimistic, pointing out that Wegovy should be easy to use. It will be dispensed as single-dosed pens that allow the patient to simply twist off the top and administer the dose. The fact that the drug has been safely used for other indications is also inspiring confidence in physicians that it can be added to lifestyle changes for certain patients focused on weight loss.
Combination therapy with the drug is also under investigation. A phase 1 study recently found that use of semaglutide (2.4 mg) with an investigational agent, cagrilintide, resulted in greater weight loss than semaglutide alone and was well tolerated (see Infographic below). The research was presented at the online 28th European Congress on Obesity (ECO 2021) meeting by Lone Enebo, PhD, and was simultaneously published in The Lancet.
In an accompanying commentary, Sara Becerril, PhD candidate, and Gema Frühbeck, MD, said: "Approved pharmacological treatment options [for overweight and obesity] are scarce and do not satisfactorily bridge the gap in efficacy between lifestyle behavioral changes and bariatric surgery to attain sustained long-term results." However, they emphasize, "Because the study was designed for safety, the weight loss outcomes need to be analyzed with caution. No lifestyle intervention was prescribed to produce weight loss...Moreover, the protocol was amended to include the highest cagrilintide dose, which might have been data driven."
Not all recent findings were positive for semaglutide. A study found that tirzepatide, a novel "twincretin" agent, was superior to 1-mg semaglutide treatments in patients with type 2 diabetes. SURPASS-2 compared three different tirzepatide doses delivered once weekly by subcutaneous injection against a 1-mg weekly, subcutaneous dose of semaglutide in 1879 adults. Patients on each of the three tirzepatide doses — 5 mg, 10 mg, or 15 mg once weekly — showed dose-dependent reductions in A1c that were significantly superior to those seen with semaglutide. Weight reduction was a key secondary endpoint; each of the three tirzepatide doses produced significant incremental loss beyond what semaglutide produced.
Although SURPASS-2 may not have favored semaglutide, interest in its potential role in aiding patients with weight loss helped the drug become this week's top trending clinical topic.
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Cite this: Ryan Syrek. Trending Clinical Topic: Semaglutide - Medscape - Jul 09, 2021.