Mounjaro (tirzepatide) is a newly approved injectable medication for treating type 2 diabetes that has also shown dramatic weight loss potential in clinical trials.
With obesity being a major health concern, many are wondering if Mounjaro can be used as an effective weight loss treatment.
What Exactly is Mounjaro?
Mounjaro is the brand name for tirzepatide, a medication recently approved by the U.S. Food and Drug Administration (FDA) as an adjunct treatment for type 2 diabetes.
It belongs to a new class of diabetic medications known as GIP/GLP-1 receptor agonists.
Mounjaro was developed by pharmaceutical company Eli Lilly and works by activating the glucose-dependent insulinotropic polypeptide (GIP) receptor and the glucagon-like peptide-1 (GLP-1) receptor, which helps to improve insulin release and sensitivity. This leads to better blood sugar control.
Mounjaro comes in pre-filled pens and syringes to be injected under the skin once per week, with approved doses ranging from 5mg to 15mg. It is to be used along with diet and exercise changes.
Evidence for Mounjaro and Weight Loss
Although Mounjaro’s FDA approval is focused on blood sugar control in type 2 diabetes, weight loss has been a very common and almost remarkable side effect observed in clinical trials.
Significant Weight Reduction Seen in Studies
In phase 3 clinical trials submitted to the FDA, participants with type 2 diabetes receiving the highest studied dose of Mounjaro at 15mg had average weight losses of up to 22.5 pounds (12.9% of body weight) over 52 weeks.
This far exceeds the 2-10 pound weight losses typically seen with other diabetes medications like metformin or SGLT2 inhibitors.
In one 56-week trial, the percentage of participants losing >=5% body weight was 86% for those on Mounjaro 15mg. For >=10% body weight loss, it was 63%. This rivals what has been seen with dedicated anti-obesity medications.
Clearly, Mounjaro has very favorable effects on weight which may translate to real world usage beyond clinical trials. However, there are some important considerations.
Is Mounjaro Approved by the FDA for Weight Loss Currently?
No, Mounjaro does not yet have FDA approval for weight loss purposes and is only indicated for glycemic control in adults with type 2 diabetes.
For a medication to gain approval for a specific use, the pharmaceutical company must conduct rigorous clinical trials to meet efficacy and safety thresholds required by the FDA.
As Mounjaro just completed trials related to diabetes, further research would be needed focusing solely on weight reduction in overweight and obese populations before approval can happen.
Potential for Future Weight Loss Approval
Given the very strong weight lowering potential displayed already, Mounjaro is likely to be investigated in obesity clinical trials to possibly gain FDA approval as an anti-obesity treatment.
In 2022, Eli Lilly announced a phase 3 trial called SURMOUNT-1 specifically examining Mounjaro for treating obesity.
If successful in larger scale trials for non-diabetic patients, experts anticipate approval for chronic weight management can come in the next 2-4 years.
This is similar to the diabetes drug liraglutide which was later developed as the popular weight loss medication Saxenda.
Access and Affordability Considerations for Using Mounjaro Off-Label
As Mounjaro currently does not have weight loss approval, any use of it for that purpose would be considered “off-label” as determined between a patient and their physician. There are some important access and cost considerations in these scenarios.
Availability May Be Restricted Initially
Being newly approved, Mounjaro is slowly launching across the United States through certain select pharmacies and specialty providers.
Not all physicians may have access right away to prescribe it. Supply constraints also exist, making broad off-label use for weight loss impractical.
However, market availability is expected to increase substantially over 2023, granting more patient access. Finding an experienced endocrinologist or weight loss focused doctor can help guide appropriate off-label use.
Out-of-Pocket Costs Could Be High
The list price for Mounjaro ranges between $900 to $1500+ for a one month supply without insurance, depending on the dosage. This is typical pricing for newer diabetic medications.
Unfortunately those using it for weight loss may face the total out-of-pocket cost if insurance does not cover non-diabetes usage. Even with coverage, copays can be 30-50% coinsurance.
Programs like Lilly’s affordability solutions, GoodRx discounts, and provider samples can help reduce costs. Over time, more competitive generics entering market could also lower prices.
Conclusion: A Promising New Option, but More Information Needed
Mounjaro has undoubtedly shown incredible weight lowering potential in clinical trials, rivaling dedicated weight loss medications. It represents an extremely promising option for those struggling with obesity.
However, prospective patients should understand it does not yet have FDA approval for weight management.
Careful discussion with healthcare providers is needed to determine if off-label use is appropriate on an individual basis.
As further research happens clarifying its efficacy and safety specifically for weight loss, approval for those indications could come shortly. This may significantly increase real-world accessibility and affordability.
Overall Mounjaro is an exciting new advancement, but more regulatory clarity over the next few years is still required to fully realize its disruptive possibilities for treating obesity.