GLP-1s have proven to be highly effective for obesity, but are extremely expensive and often have serious side effects, such as nausea, vomiting, dizziness and fatigue.
That’s why Noom, a digital weight loss company, has introduced microdosing for GLP-1s. The company’s program involves beginning with a very low dose and gradually increasing to no more than 25% of the standard maintenance dose, with the goal of finding the lowest effective amount that supports weight loss while minimizing side effects and reducing cost.
The offering starts at $119 per month and uses compounded GLP-1s, which are custom-made by compounding pharmacies and include the same active ingredient found in branded GLP-1s. Compounded GLP-1s are controversial because they are not FDA approved and many physicians believe the compounded versions can harm patients, but they are a cheaper alternative to the branded drugs. When there was a shortage of GLP-1s, the compounded versions became immensely popular, though now some companies like Hims & Hers are facing scrutiny from Novo Nordisk due to the sale of compounded GLP-1s. Novo Nordisk recently terminated a partnership with Hims & Hers because of its continued prescribing of these drugs.
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Currently, physicians can prescribe compounded medications if an FDA-approved drug is not medically appropriate to treat a patient. Hims & Hers, however, does not provide microdosing for GLP-1s, the company confirmed to MedCity News.
Is this microdosing program safe and effective? Noom says that due to the smaller doses, patients reduce the risk and intensity of side effects. The company also provides clinical oversight to ensure safety.
However, at least one obesity medicine specialist isn’t so convinced that Noom’s microdosing offering is safe. And the concern isn’t so much with the prescribing of smaller doses, but the use of compounded GLP-1s, as they are not FDA-approved.
“The microdosing itself is not necessarily an issue. … For example, for patients on Ozempic for diabetes, we would off-label do this once in a while, especially when patients had more gastrointestinal side effects or they were losing weight faster than they wanted. … What I sort of take issue with Noom is that, one, I don’t know what medication or even substance somebody’s pumping into their bodies. And then two, what are the actual doses? Or what are the actual equivalents [compared to branded GLP-1s]?” argued Dr. Disha Narang, an endocrinologist and director of obesity medicine at Endeavor Health.
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She noted that the only branded GLP-1 that can be microdosed is Ozempic because it comes in a clickable pen, and it’d have to be done off-label. The others are only one-time use.
Noom’s program
In order to be eligible for Noom’s Microdose GLP-1 Program, patients must have a body mass index of 25 or higher. They start with an intake survey in which they share their medical history and weight loss goals. A clinician reviews their results and provides a prescription if they consider the patient clinically appropriate.
Patients start with a dose of 0.2 mg, which can then be gradually adjusted to a maximum of 0.6 mg if needed. Every two weeks, a Noom clinician assesses progress and determines whether the dose should stay the same, increase slightly or decrease. The typical dose of semaglutide is .25 mg to 2.4 mg.
“Noom has never stood for just moving people up to that highest dose they could possibly tolerate. We think that is not the right way to dose, and it’s instead about the lowest dose to help patients achieve a health goal,” said Geoff Cook, CEO of the company, in an interview.
In addition to the prescription, patients receive access to Noom’s GLP-1 companion educational program, 24/7 messaging with clinicians and care coordinators and one-on-one health coaching.
The company pointed to several studies that show the effectiveness of this microdosing approach. For example, one study sponsored by Novo Nordisk published in the New England Journal of Medicine found that patients achieve weight loss at about 20% and 40% of the full dose. In addition, preliminary data on Noom’s microdosing program found that 70% of patients report no side effects at all.
What others think about the program
Dr. Narang of Endeavor Health is not the only person skeptical of the compounded microdosing program because it doesn’t have FDA approval.
“While taking lower doses are not wrong or harmful (as long as you are using FDA approved versions and not compounded versions) they may not be effective so might not be worth the money. We do not know the safety or efficacy of compounded GLP-1 medications and at any dose the risk/benefit of these medications currently favors more risk than benefit,” said Dr. Angela Fitch, co-founder and chief medical officer of metabolic health company knownwell. Fitch is also the former president of the Obesity Medicine Association.
Narang of Endeavor Health emphasized that when it comes to compounded GLP-1s, it’s hard to know what’s actually being put into people’s bodies. She feels like the GLP-1 market has become extremely unregulated and that there is very little data to support the microdosing of compounded GLP-1s.
Noom, meanwhile, emphasized that it takes all the necessary measures to ensure safety. The company only works with state-licensed, United States Pharmacopeia-compliant compounding pharmacies. It sources its ingredients from FDA-registered facilities, and each batch is tested by a third party. Patients can also request a Certificate of Analysis from their care coordination team, which shows that the medication meets regulatory requirements.
“Compounding has really been around and has been a tool for physicians and patients since the beginning of medicine or before,” said Dr. Jeffrey Egler, MD, chief medical officer at Noom, in an interview. “So this is just utilizing a tool that allows us to give people what they really need and to help them find their lowest effective dose, rather than begrudgingly going through a process that’s less efficacious and results in less success.”
It’s worth noting that while physicians and pharma companies are concerned over the safety of compounded GLP-1s, ironically there are lawsuits tied to the safety of branded GLP-1 drugs. Cases have been brought against Novo Nordisk and Eli Lilly, alleging that they failed to warn consumers about the dangerous side effects of weight loss drugs, such as sudden blindness and persistent vomiting that causes hospitalization. This includes the popular Ozempic, Wegovy and Mounjaro medications.
While Narang and Fitch have reservations about Noom’s microdosing program, other company executives believe it shows promise. This includes Dr. Jennifer Peña, chief medical officer at Wisp, an online sexual and reproductive health company that also offers weight care.
“Programs like this that support microdosing of GLP-1 medications can be a smart, safer alternative for certain people, especially if higher doses cause unwanted side effects or aren’t necessary to achieve meaningful results,” Peña said.
She added that Wisp is not currently offering a microdosing approach, but would consider it if supported by robust research and clinical guidelines.
Peña’s comments were echoed by Dr. Rishi Khakhkhar, chief medical officer at Counsel Health, a company that provides on-demand medical advice.
“From a safety standpoint, one of the main reasons patients stop GLP-1s is gastrointestinal side effects,” Khakhkhar said. “Microdosing could be one strategy to help reduce those issues and improve adherence. The evidence is still emerging, and patients on microdoses should be monitored by a responsible care team just like patients on full doses.”
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