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Mounjaro, New Type 2 Diabetes Drug From Lilly, Gets U.S. Approval

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Mounjaro, New Type 2 Diabetes Drug From Lilly, Gets U.S. Approval

The U.S. Food and Drug Administration (FDA) has approved a new injectable drug for type 2 diabetes, Mounjaro (tirzepatide) — representing the first GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist approved in the United States, according to an announcement from its manufacturer, Lilly.

Mounjaro is unique among currently approved drugs in that it activates receptors for two different kinds of hormones — GIP and GLP-1 — that the body doesn’t make enough of in people with type 2 diabetes. A few other drugs belong to the family of GLP-1 agonists, which activate the receptors for this hormone. GLP-1 agonists include Byetta and Bydureon (exenatide), Ozempic and Rybelsus (semaglutide), Victoza (liraglutide), Trulicity (dulaglutide), and Adlyxin (lixisenatide). GLP-1 agonists are some of the most effective drugs for blood glucose control in type 2 diabetes, yet they remain underused, especially among ethnic and racial minorities in the Unites States. In addition to their beneficial effect on blood glucose control, these drugs have been linked to a lower risk of death in people with kidney disease, and they may also reduce the risk for glaucoma, an eye disorder that can lead to blindness.

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Mounjaro approved based on SURPASS results

As the announcement notes, Mounjaro was approved based on results from a study known as SURPASS, which compared the drug with Ozempic, insulin glargine, and insulin degludec (two types of long-acting insulin). Study participants who took Mounjaro (based on random selection) received it in a dose of 5, 10, or 15 milligrams weekly, either alone or in combination with other commonly prescribed diabetes medications. Over the course of 40 weeks, participants who took Mounjaro experienced an average reduction in A1C (a measure of long-term blood glucose control) of 1.87% for 5 milligrams weekly, 1.89% for 10 milligrams weekly, and 2.07% for 15 milligrams weekly. In contrast, participants who took a placebo (inactive injection) saw an average increase in A1C of 0.04%.

Mounjaro
Mounjaro. Image courtesy Eli Lilly.

Participants who took Mounjaro also tended to lose body weight — an average of about 12 pounds for those who took 5 milligrams weekly, and about 25 pounds for those who took 15 milligrams weekly. Mounjaro was not prescribed and is not intended for weight loss, but this may be a beneficial side effect of taking the drug. The drug can also cause some unpleasant side effects — with nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion (dyspepsia), and stomach (abdominal) pain each reported by at least 5% of study participants.

Mounjaro is expected to become available through the United States in the coming weeks. For more information about the drug, visit the official website from Lilly or talk to your doctor about whether it may be a good option for you.

Want to learn more about type 2 diabetes? Read “Diagnostic Tests for Type 2 Diabetes” and “Welcome to Diabetes.”

Quinn Phillips

Quinn Phillips

Quinn Phillips on social media

A freelance health writer and editor based in Wisconsin, Phillips has a degree from Harvard University. He is a former Editorial Assistant for Diabetes Self-Management and has years of experience covering diabetes and related health conditions. Phillips writes on a variety of topics, but is especially interested in the intersection of health and public policy.

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