Who uses GLP-1 drugs, and for what? Is it worsening diabetes drug shortages?

• The last few years have seen a marked increase in the use of glucagon-like peptide-1 receptor agonists (GLP-1 agonists) used for managing type 2 diabetes and as a way to lose weight.
• This rapid increase in users of GLP-1 drugs has caused worldwide shortages of these medications for people with type 2 diabetes who need them.
• A new study reports that of the 1 million new GLP-1 medication users identified between 2011 to 2023, there was a twofold increase in GLP-1 medication users who do not have type 2 diabetes.
• Researchers also found the proportion of users of GLP-1 medications without FDA-approved indications rose from 0.21% in 2019 to 0.37% in 2023.

Over the last few years, the use of glucagon-like peptide-1 receptor agonists (GLP-1 agonists) for managing type 2 diabetes has dramatically increased. This is mainly because of the reported weight loss side effect that many people experience when on these medications.

While GLP-1 medications Zepbound and Wegovy have received Food and Drug Administration (FDA) approval for weight loss in people with obesity, many are using other GLP-1 drugs, such as Ozempic , for weight loss off label.

This rapid increase in users of GLP-1 drugs has caused worldwide shortages of these medications for people with type 2 diabetes who need them.

Now, a new study published in Annals of Internal Medicine , reports that among the approximately 1 million new GLP-1 medication users identified between 2011 to 2023, there was a twofold increase in GLP-1 medication users who do not have type 2 diabetes but do have a body mass index (BMI) of 30 killograms per square meter (kg/m ² ) or greater, and in people with a BMI of 27 to 30 kg/m ² and an obesity-related comorbid condition .

The researchers also found that the proportion of users of GLP-1 medications without FDA-approved indications rose from 0.21% in 2019 to 0.37% in 2023.

Twofold increase in GLP-1 drug users without diabetes

For this population-based study, researchers used medical records from about 45 million people in the United States listed in the TriNetX real-time federated health research network who all had at least one outpatient or inpatient doctor visit between 2011 and 2023.

Scientists accessed medical information for each study participant, including BMI, demographic data, diagnoses, and prescriptions.

Upon analysis, researchers found there were about 1 million new users of GLP-1 medications between 2011 and 2023.

While during this time frame the percentage of new users with type 2 diabetes decreased, there was a twofold increase in the proportions of users without type 2 diabetes and a BMI of 30 kg/m ² or greater, as well as in participants with a BMI of 27 to 30 kg/m ² and an obesity-related comorbid condition.

Kevin Sheng-Kai Ma, DDS, FRSPH, FRSM , international scholar at the Center for Global Health at the Perelman School of Medicine at the University of Pennsylvania and lead author of this study, told Medical News Today that he and his colleagues “were not surprised by these findings, as these [obesity and obesity-related issues] are indications for GLP-1RA that have been approved in recent years.”

“That said, clinicians are encouraged to monitor and continue assessing patients receiving GLP-1RA [drugs],” he advised.

The researchers also discovered the quantity of GLP-1 medication users without FDA-approved indications increased from 0.21% in 2019 to 0.37% in 2023.

“This data suggests that more healthcare providers are seeing the benefits of these medications for treating obesity, which is a significant public health shift,” Yee Hui Yeo, MD , a clinical fellow in the Karsh Division of Gastroenterology and Hepatology at Cedars-Sinai and co-first author of the study said in a press release .

Racial, ethnic disparities for GLP-1 drug access

Scientists also uncovered some gender and ethnic disparities in the use of GLP-1 medications.

Researchers reported that between 2011 and 2023 the largest users of semaglutide were disproportionately female, non-Hispanic white.

“We hope our findings will inform healthcare policies and promote equitable access to these essential treatments,” Yeo said in the press release.

David Cutler, MD , a board-certified family medicine physician at Providence Saint John’s Health Center in Santa Monica, CA, who was not involved in this study, told MNT that the current economics of supply and demand for GLP-1 medications makes health disparities unavoidable.

“Health insurance companies and health plans vary greatly in how policies cover weight loss drugs,” Cutler explained.

“There is also variability in how they cover the drugs when used for diabetes. Regardless of which drug or which disease, access to the drug may be limited to some patients due to cost. This inevitably leads to racial, ethnic, and other socioeconomic disparities in access. Since control of diabetes and obesity are significant health outcome risk factors, it is conceivable that the shortages and high cost of GLP1 agonists will exacerbate existing health disparities.”

– David Cutler, MD

His perspective echoed what Ma told us, namely that “[o]ne of the biggest bottlenecks with GLP-1RA access is cost and insurance.”

“Even if a doctor prescribes [this type of drug], patients cannot obtain it if their insurance does not cover it, which could worsen disparities, especially for those with public insurance or in underserved populations,” he also emphasized.

“We need to work with insurance and health policy to establish criteria for qualifying for GLP-1RA and to advocate for people for whom other standard medications cannot substitute for GLP-1RA,” the researcher went on to say.

GLP-1 drug shortage is a daily struggle for some

In regards to the current GLP-1 medication shortage, Cutler said this is a topic and a struggle he deals with on a daily basis.

“It is no secret that GLP-1 agonist medications like semaglutide — Ozempic, Wegovy — have demonstrated both effectiveness and popularity for treating obesity ,” he told us.

“One consequence of this popularity is that despite their high cost, the GLP-1 agonist medications have seen demand outstrip their supply resulting in shortages making their availability to treat diabetes more limited. So, it is not surprising to see studies in medical journals documenting not only this increased demand, but also resulting shortages, and postulating on methods of obtaining these medications for those people who more desperately need them for diabetes than for weight loss,” said Cutler.

MNT also spoke with Mir Ali, MD , a board-certified bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA, who was also not involved in this study, about its findings.

Ali agreed with Cutler that the findings, while concerning, were unsurprising.

“This is a trend we’ve been seeing and it’s been seen by other studies as well that there’s a shortage of these medications because it’s a much broader indication now than just diabetics — it’s patients who are obese and don’t have diabetes can get these medications,” he told us.

“The typical hurdles our patients are facing is first, getting covered by insurance , which is another separate issue because if there were more people covered, there’d be an even greater shortage of these medications,” said Ali.

How can the GLP-1 drug shortage be solved?

When asked what steps need to be taken to solve the current GLP-1 medication shortage, Cutler said that fixing it is a complex task due to the complexity of pharmaceutical licensure, manufacturing, and distribution.

“The company which manufactures brand name semaglutide […] brings billions of dollars into the Danish economy through sales of this drug,” he opined. “However, they are now seeing competition from other companies manufacturing ‘compounded’ or non-branded semaglutide, which is bringing the price down. However, these medications are not FDA-approved, so buyer beware.”

“The competing GLP-1 drug tirzepatide ( Mounjaro , Zepbound ) is similarly branded by a single company,” Cutler continued. “They, too, benefit from FDA approval protecting their brand from competition. But there are also non-branded, non-FDA approved options available at lower cost.”

Ali’s suggested solution relied on drug manufacturers increasing the production of GLP-1 medications as much as possible.

“It seems like the manufacturers are making as much as they can, but maybe they have some capacity to increase that,” he hoped.

And Cutler mentioned there is now ongoing research examining the impact of GLP-1 medications on metabolic diseases, such as metabolic-associated steatohepatitis (MASH), formerly known as nonalcoholic fatty liver disease .

“While this research may widen the indications and temporarily worsen the shortage of these agents, in the long run, the health benefits may be significant,” he added. “Current research on the relative benefits and safety of non-FDA approved alternatives compared to the more expensive agents may help improve access to GLP-1 agonists.”