FDA Approves Mounjaro (Tirzepatide) for Diabetes Treatment
By Matthew Garza
Mounjaro (tirzepatide), a first-of-its kind medication for treating type 2 diabetes, has been approved by the FDA after much anticipation. This new medication has been shown to dramatically lower A1C and weight in clinical trials.
In May 2022, the FDA approved Lilly’s new medication Mounjaro (also known as tirzepatide) for type 2 diabetes management, in addition to diet and exercise. This first-in-class medication has been shown to improve glucose levels and also dramatically improve weight in clinical trials.
“This approval marks the first new class of diabetes medications in almost 10 years,” said Dr. Charles Alexander, an endocrinologist and diaTribe’s scientific and medical advisor. “We have known about the GIP receptor for over 50 years, but initial studies led scientists to believe that it would not have any role in the treatment of diabetes. How wrong they were! Many people with type 2 diabetes will immensely benefit from this new class of medicines.”
Learn more about this new medication and what its approval means for people with diabetes.
What is Mounjaro (tirzepatide)?
Mounjaro is a once-weekly injectable medication that will be available as an auto-injector pen. This new glucose-lowering therapy is called a "dual agonist" or a “dual GIP and GLP-1 receptor agonist.” It’s similar to GLP-1 receptor agonists – which have been shown to lower glucose levels, lead to weight loss, and lower the risk of heart disease – but Mounjaro adds a GIP receptor agonist.
Mounjaro is the first dual GIP and GLP-1 receptor agonist to be approved by the FDA. GIP and GLP-1 are two hormones that the body makes which are normally released with meals. This medication is designed to help mimic both natural agonists (GIP and GLP-1) so the molecule can bind to their receptors. Simply put, an agonist is like a key that fits in the locks (the receptors) and turns it to open the doors to help manage glucose levels and also cause weight loss.
Mounjaro was approved at three different doses – 5 mg, 10 mg, and 15 mg. Healthcare professionals may adjust the dose depending on the person’s response to the medication and health goals.
When will Mounjaro become available?
Lilly has announced that this medication will be available in the US "in the coming weeks." We will continue to update this article as we learn more.
How much will Mounjaro cost?
Lilly has not announced the list price of Mounjaro yet. The company has announced that for qualifying people, they plan to independently offer a savings card to receive Mounjaro for as little as $25 per month out-of-pocket.
Unfortunately at this time, this savings card will not be available to those on Medicaid and Medicare.
For questions about Mounjaro you can visit www.Mounjaro.com or call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).
What does the research on Mounjaro show?
The research on Mounjaro has been overwhelmingly positive. The medication has been studied in a number of clinical trials, most notably the SURPASS trials (which includes five completed studies and two ongoing studies).
In the trials submitted to the FDA for this approval – all three doses of the medication were compared to a placebo, a GLP-1 receptor agonist (semaglutide – also known as Ozempic), and two different long-acting insulins (insulin degludec and insulin glargine). The results from these trials showed Mounjaro did better than the comparison drugs for both A1C reduction and weight loss.
The medication is also being studied in people with overweight or obesity without type 2 diabetes (SURMOUNT), but those trials are still ongoing and will require a separate FDA approval.
You can read our coverage of the SURPASS trials in our article, “Tirzepatide Dramatically Lowers Weight and A1C.” Mounjaro led to an average 2.0 percentage point A1C reduction across all SURPASS trials, and all groups taking a 15 mg dose of tirzepatide had an average A1C below 6%. On average, at the highest dose of 15 mg, Mounjaro lowered trial participants’ A1C by:
1.6 percentage points more than placebo when used as stand-alone therapy.
1.5 percentage points more than placebo when used in combination with a long-acting insulin.
0.5 percentage points more than semaglutide.
0.9 percentage points more than insulin degludec.
1.0 percentage points more than insulin glargine.
In addition, Mounjaro helped trial participants lose
15 pounds more than placebo when neither were used with insulin.
23 pounds more than placebo when both were used with insulin.
12 pounds more than semaglutide.
29 pounds more than insulin degludec.
27 pounds more than insulin glargine.
And in recent results from SURMOUNT-1, which included 2,539 participants with overweight or obesity who did not have diabetes, Mounjaro was shown to lower body weight by 22.5% at the highest dose of 15 mg. In the 15 mg group, 63% of participants achieved a weight loss of over 20% of their body weight.
Does Mounjaro have side effects?
Mounjaro has been shown to cause nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort and abdominal pain in some people who take it.
Who can be prescribed Mounjaro?
At this time, Mounjaro has only been approved for adults with type 2 diabetes, as an addition to diet and exercise. Mounjaro is not approved for children and teens, people with type 1 diabetes, or people without type 2 diabetes.
Learn more about Mounjaro
To learn more about this exciting new medication and its performance in clinical trials check out our articles on the subject: