Over 1.1 million Americans received off-label GLP-1 prescriptions, study finds

A new study by researchers at New York University reveals that over 1.1 million Americans without an FDA-approved indication—such as obesity or type 2 diabetes—were prescribed GLP-1 medications like Ozempic and Wegovy between 2021 and 2025. The findings raise questions about the safety, equity, and motivations behind the surge in off-label use of these drugs.

Off-label GLP-1 prescriptions surge

A study conducted by researchers at New York University found that more than 1.1 million Americans without an FDA-approved indication for GLP-1 medications—such as obesity or type 2 diabetes—were prescribed drugs like Ozempic, Wegovy, and Mounjaro between 2021 and 2025. According to Gizmodo, the analysis drew from the COSMOS dataset, which includes over 300 million patient records from hospitals and clinics across the U.S. and other countries.

The researchers focused on adults who had no current diagnosis of type 2 diabetes, obesity, or overweight with weight-related complications. Among this group, the rate of GLP-1 prescriptions rose from 0.11% in 2021 to 1.5% in 2025, representing a 13.6-fold increase in off-label use.

The study also revealed that roughly a third of those prescribed GLP-1 medications off-label had a normal body mass index (BMI). This subgroup was six times more likely to have a history of eating disorders compared to non-users of GLP-1 drugs.

Demographics and disparities

Off-label prescriptions of GLP-1 medications were not evenly distributed across populations. According to the study, women, white people, and individuals with private insurance were more likely to receive these drugs without an approved indication. The data also suggested that people from less socially vulnerable areas were overrepresented among off-label users.

The study did not include data on compounded GLP-1 medications, which may be used by individuals without clear medical justification. This omission could understate the full scope of off-label use.

Potential and risks of off-label use

GLP-1 medications have shown promise for treating conditions beyond obesity and type 2 diabetes. For example, research is underway to explore their potential for addressing substance use disorders and other health issues. However, the study’s authors emphasized that the risks and benefits of off-label use remain uncertain for many patient groups, particularly those not studied in clinical trials.

A separate 2024 study estimated that expanding access to GLP-1 medications for all eligible Americans could save roughly 40,000 lives annually. This highlights the potential public health benefits of these drugs—but also the importance of ensuring they are prescribed safely and equitably.

What this means

LazyFounders analysis — our interpretation, not reported fact.

This study underscores a growing tension in healthcare: the rapid adoption of powerful medications like GLP-1s for uses beyond their approved indications. For founders and operators in the health and biotech spaces, this trend highlights critical questions about access, equity, and responsibility.

Off-label use isn’t new, but the scale and speed of GLP-1 adoption—fueled by demand, hype, and aggressive marketing—create unique challenges. The data suggests these drugs are being prescribed disproportionately to groups with better access to healthcare, such as those with private insurance or lower social vulnerability. This risks widening disparities in who benefits from medical innovation.

For startups in this space, the takeaway is clear: evidence matters. The study’s findings about eating disorder history among off-label users are a reminder that these drugs aren’t without risk, especially for populations not studied in clinical trials. Companies building products or services around GLP-1s—whether for weight loss, mental health, or other conditions—must prioritize rigorous data collection and transparency.

Regulators and payers will likely scrutinize off-label use more closely as adoption grows. Founders should anticipate pushback if their business models rely on off-label prescriptions without clear safety and efficacy data. At the same time, the potential for GLP-1s to treat conditions like substance use disorders is a significant opportunity—but one that demands patience and collaboration with researchers and clinicians.

Key takeaways

• Over 1.1 million Americans received off-label GLP-1 prescriptions between 2021 and 2025, based on an NYU study.
• Off-label use surged 13.6-fold during this period, with prescriptions rising from 0.11% to 1.5% among those without approved indications.
• A third of off-label users had a normal BMI, and this group was six times more likely to have a history of eating disorders.
• Women, white people, and those with private insurance were more likely to receive off-label prescriptions.
• GLP-1 medications are being explored for conditions beyond obesity and diabetes, but off-label use raises safety and ethical questions.

FAQ

What are GLP-1 medications?

GLP-1 medications, such as Ozempic, Wegovy, Mounjaro, and Zepbound, are drugs originally developed to treat type 2 diabetes and obesity. They work by mimicking a hormone that regulates blood sugar and appetite.

What does "off-label" mean in this context?

Off-label use refers to prescribing a medication for a purpose or patient group not approved by the FDA. In this case, it means prescribing GLP-1 drugs to people without obesity, type 2 diabetes, or weight-related complications.

Why are off-label prescriptions a concern?

Off-label use can pose risks if the drug’s safety and efficacy haven’t been studied for the unapproved condition or population. The NYU study highlights concerns about prescribing GLP-1s to people with normal BMIs or histories of eating disorders, groups not included in clinical trials.

Who is most likely to receive off-label GLP-1 prescriptions?

According to the study, off-label prescriptions were more common among women, white people, those with private insurance, and individuals from less socially vulnerable areas.

Could off-label use of GLP-1s have benefits?

While the study focuses on risks, GLP-1 medications are being researched for other conditions, such as substance use disorders. However, their safety and efficacy for these uses are not yet fully established.

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