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The proportion of new users of GLP-1 receptor agonists without type 2 diabetes markedly increased over the past decade, and particularly since 2020, according to a nationwide population-based study of prescribing trends.

Overall, the annual incidence of new GLP-1 agonist prescriptions increased from about 0.5% in 2019 to over 3% in 2023, reported Yee Hui Yeo, MD, MSc, of Cedars-Sinai Medical Center in Los Angeles, and colleagues.

And during that timeframe, there was a decreasing trend in the proportion of new GLP-1 users with type 2 diabetes (from nearly 90% to a little over 70%) but a twofold increase in the proportion of users without type 2 diabetes but either a BMI of 30 or greater or a BMI of 27 to 30 and an obesity-related comorbidity (increasing from about 10% to roughly 25%), the authors noted in their brief report in the .

Of note, the proportion of people who didn't have an FDA-approved indication for a GLP-1 receptor agonist increased from 0.21% in 2019 to 0.37% in 2023.

"Essentially, after the medication was approved for obesity, GLP-1 RA [receptor agonist] use took off so quickly that we lost control and vision of how fast people were picking up these medications, and the trends of use are uncertain," said co-author Ali Rezaie, MD, MSc, also of Cedars-Sinai Medical Center, in a statement. "While GLP-1 RAs offer several benefits, they are also associated with various common and uncommon side effects, necessitating careful monitoring of their prescription patterns."

Semaglutide (Ozempic, Wegovy), which constituted 88.1% of all new GLP-1 receptor agonist prescriptions in 2023 -- up from 31.4% in 2019 -- gained an indication for chronic weight management in 2021, years after being approved for type 2 diabetes. It also gained a major heart disease prevention indication earlier this year.

Of note, tirzepatide (Mounjaro, Zepbound) wasn't included in this analysis. This GLP-1/GIP agent was approved in 2022 for type 2 diabetes and in 2023 for chronic weight management. According to a recent real-world analysis, tirzepatide is currently the most effective GLP-1-containing agent for weight loss on the market.

"The recent approval of tirzepatide for weight control in persons without diabetes and the FDA approval of the use of GLP-1 RAs to reduce cardiovascular disease risk will further broaden the indications of GLP-1 RAs and affect access," the researchers pointed out.

The overall findings of this study largely confirm what was reported in a , which showed that over 1.1 million patients were prescribed a GLP-1 agent from 2018 to 2024. Similarly, another study reported a near 600% increase in GLP-1 prescriptions for adolescents and young adults from 2020 to 2023, growing from 8,722 to 60,567 per month.

"These data suggest that more healthcare providers are seeing the benefits of these medications for treating obesity, which is a significant public health shift," Yeo said in a statement. "However, it also raises concerns about potential medication shortages and the need to ensure that patients with diabetes still have access to these treatments."

The researchers hope that these findings will inform healthcare policies and promote equitable access to these essential treatments, Yeo added.

For this study, the authors used data from TriNetX, a federated health research network with de-identified records on about 45 million patients with at least one outpatient or inpatient visit in the U.S. during 2011 through 2023.

Overall, there was 871,854 incident GLP-1 users from 2011 to 2023 -- beyond semaglutide these included exenatide (Byetta, Bydureon), liraglutide (Victoza, Saxenda), dulaglutide (Trulicity), albiglutide (now discontinued), and lixisenatide (now discontinued). From 2011 to 2014, there were 27,367 new users, and this number jumped to 131,029 from 2015 to 2018. Finally, from 2019 to 2023, this number ballooned to 679,265.

New GLP-1 users were disproportionately female and white, with a BMI of 30 or greater. Average age of users was 54.6; 59.5% had type 2 diabetes, 61.3% had hypertension, 17.9% had ischemic heart disease, and 9.3% had cerebrovascular disease.

The study data are only reflective of healthcare organizations included in TriNetX, which may not be representative of the entire U.S. population. This study also did not include patients who were prescribed GLP-1 receptor agonists outside of healthcare organizations, like through online platforms.

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