![]() The historic results of the landmark trial-which concluded use was associated with a mean 14.9% reduction in body weight with semaglutide 2.4 mg compared to 2.4% with placebo therapy-sent the interest level in semaglutide 2.4 mg skyrocketing. Published in the NEJM in March 2021, the STEP 1 trial randomized adults with obesity or overweight plus 1 weight-related condition who did not have diabetes to semaglutide 2.4 mg or placebo for 68 weeks. The most significant event leading to the ascent of semaglutide into the conscience of the medical community and general public prior to 2023 occurred with the first release of results from Novo Nordisk’s STEP program, which began in 2021 with the STEP 1 trial. 4,5 Although these trials and expanded indications contributed to increased demand for the agent, its use in real-world settings remained limited to patients with type 2 diabetes. A clinical program containing 8 trials, the SUSTAIN program would go on to serve as the basis for additional approvals for cardiovascular risk reduction in adults with type 2 diabetes and known cardiovascular disease in 2020 and semaglutide 2.0 mg in 2022. 3īased on the results of Novo Nordisk’s SUSTAIN program, semaglutide 0.5 mg and 1.0 mg (Ozempic) received initial approval from the FDA in 2017 as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes. Published in the New England Journal of Medicine ( NEJM) in July 2016, results of the LEADER trial, which included 9340 adults with type 2 diabetes, concluded use of the GLP-1 receptor agonist was associated with a significant reduction in the risk of major adverse cardiovascular events, including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, compared to placebo. Launched in 2010, the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial sought to explore the long-term effects of liraglutide on cardiovascular outcomes and other clinically important events. Few, if any, could have predicted how the development of liraglutide would set the stage for semaglutide in the next decade and a half. Between 2005 approval and the 2017 approval of semaglutide, 5 other GLP-1 receptor agonists received approval and came to market, including Novo Nordisk’s liraglutide (Victoza), which received approval in January 2010. In 2005, exenatide (Byetta) became the first GLP-1 receptor agonist to receive approval from the FDA. Although there has been a demonstrative increase in interest and demand for semaglutide in 2023, the origins of its ascent into the spotlight predates the agent’s 2017 approval by more than a decade. Just 6 years removed from the GLP-1 receptor agonist’s initial approval by the US Food and Drug Administration (FDA) for improving glycemic control in type 2 diabetes (T2D) in 2017, the agent is now positioned at the center of discussions across disciplines in medicine and beyond, as evidenced by the historic demand and ongoing shortage of the agent.
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