Over the past few years, drugs like Wegovy, Ozempic, and Mounjaro have become household names, sparking worldwide conversations about weight loss, diabetes care, and the future of medicine. Demand for these medications, known as GLP-1s, has skyrocketed, but with that demand has come a shadow market: unregulated, compounded versions of GLP-1 drugs being sold online, often with misleading claims about safety and approval.
To better understand this growing trend, Michael J. DiStefano, PhD, Assistant Professor in the Center for Pharmaceutical Outcomes Research, and a team of researchers from CU Pharmacy have been studying the direct-to-consumer market for compounded GLP-1s, first only in Colorado, and now, a second study, with expanded states. Their findings raise important questions about patient safety, affordability, and the role of regulation in a fast-moving healthcare landscape.
In this Q&A, Dr. DiStefano shares his insights on the risks of compounded GLP-1s, how celebrity culture and rising costs are shaping demand, and what consumers should know as new weight-loss treatments seem too good to be true.
In your original Colorado-only study, many websites selling compounded GLP-1 drugs claimed their products were “FDA-approved” or even “generic,” even though they weren’t. How can everyday people tell the difference between safe, approved medications and misleading online and social media ads?
People pursuing GLP-1s shouldn’t be afraid to speak with their doctors about the option of compounded products, and they shouldn’t be afraid to ask telehealth companies, clinics, or med spas questions like: Are your products compounded? Do you add any other ingredients? Where do you source your compounded product? Regarding claims about the benefits or safety of these products, consumer ads from the branded manufacturers (i.e. Novo Nordisk and Eli Lilly) are subject to FDA regulations requiring accuracy and a fair balance in the discussion of benefits and risks. But claims on the websites of weight loss clinics or med spas don’t necessarily receive this attention from the FDA or other institutions that seek to protect consumers (e.g. the FTC). So, in general, you should be very skeptical of claims about benefits and safety that are made by these clinics and spas and that go beyond what you see in manufacturer ads.
Serena Williams recently shared that she lost over 30 pounds using a GLP-1. Do you think high-profile stories like hers are fueling demand for compounded versions of these medications online?
Yes, absolutely, although I’m not sure whether Serena Williams herself has used a compounded or branded GLP-1 product. Much of the initial skyrocketing demand for these products — either branded or compounded — that we saw a few years ago definitely seems to have been driven by celebrity use and viral social media posts. Something to note about Serena Williams’ case is that, as an elite athlete, she has spent a lifetime developing habits that will help her to be successful on a GLP-1. It’s important that others turning to GLP-1s also do their best to explore what lifestyle changes they can make to improve their chances of long-term success with these medications.
Your research highlights cost as a big reason people turn to compounded GLP-1s. With headlines showing skyrocketing demand and price differences for drugs like Wegovy and Mounjaro, how much is affordability driving people toward riskier, unapproved options?
Many commercial payers and state Medicaid programs are reluctant to cover these drugs given the substantial budget impact and uncertainty regarding the potential for longer-term cost offsets. At the same time, Medicare is prohibited from covering these drugs if intended for weight loss only. So it’s true that many people, if they cannot get insurance coverage, may consider compounded versions. That said, the compounded versions may still cost several hundred dollars per month, so they are not amazingly cheap. One thing people worried about cost should be aware of is that semaglutide (the active ingredient in Ozempic and Wegovy) was selected for the Medicare Price Negotiation Program. This means that, effective January 2027, semaglutide may see a significant price drop. This could have spillover effects on prices outside the Medicare market and on competitor drugs like tirzepatide.
Some compounded GLP-1 products are mixed with other substances the FDA has called unsafe. What are the biggest dangers for patients who may not realize what’s in the medication they’re buying online?
We did identify one instance of a clinic in Colorado advertising a GLP-1 compounded with BPC-157, a peptide about which the FDA lacks adequate safety information and has stated may trigger an immune response. It is much more common to see compounded products that combine GLP-1s with B vitamins. While I can’t speak to whether this is an unsafe combination, I do wonder how this combination would impact the effectiveness of the GLP-1. We certainly do not have high-quality clinical trials of the type required for FDA approval that have studied this combination of ingredients.
Some people are now “microdosing” GLP-1 drugs, often through compounded versions, as a cheaper or gentler option. Did you come across this in your research, and what should people know about it?
This was not a focus of our previous research, but it is something we are now looking more into. During the shortage of semaglutide and tirzepatide, compounders could legally produce copies of the branded products. But now that the FDA has determined this shortage to have resolved, only formulations tailored for specific patient needs should be compounded. One way to do this could be through specialized dosing regimens, like microdosing. However, it’s hard to see how such small doses could be effective. Manufacturers spend a lot of resources over the course of many clinical trials figuring out the right dosing regimen.
Your previous work focused on compounded GLP-1 products only in Colorado, but you’ve secured a grant to expand this research nationwide, looking at telehealth platforms, weight-loss clinics, and med spas across multiple states. What new patterns or challenges are you hoping to uncover, and how might these findings influence the future of safe, affordable access to GLP-1 weight-loss treatments?
We’ve expanded the work to states where we think demand for compounded GLP-1 products might be higher than in Colorado. After all, Colorado has the lowest rate of obesity in the US outside of DC. We are also hoping to better understand the personal experiences of people who have used compounded GLP-1 products. Finally, we are interested in better understanding how the market for these compounded products has changed since the FDA declared an end to the shortages of semaglutide and tirzepatide.
