New Type 2 Diabetes Treatment - Mounjaro
Just before the ADA meeting there was a big announcement of the FDA approval of a new Type 2 diabetes medication that has the promise of superior glucose control and weight reduction.
This new drug is called Mounjaro (Tirzepatide) and is a dual GIP + GLP-1 receptor agonist. You may be aware of the current GLP-1 medications on the market sold as Trulicity and Ozempic. Mounjaro works by adding the additional incretin hormone known as GIP to the mix. This is the first approved medication in this class.
We have been following the clinical trials results with over 6,000 participants that showed an A1c reduction of 1.9 to 2.6% with no increased risk for hypoglycemia. The A1c reduction was greater than that seen with the 1 mg dose of Ozempic or the basal insulins Lantus or Tresiba. This data on glucose control was convincing enough for the FDA to grant approval.
The other benefit of the medication is a significant weight loss of weight which was greater than seen with 1 mg of Ozempic. There are also ongoing trials that are looking at the role of appetite reduction and weight loss in people without diabetes. If approved, this could compete with the Wegovy, which is 2.4 mg/week the highest dose of semaglutide (Ozempic).
The medication is administered in a once-weekly injection using a similar simple delivery device that is used by Trulicity which hides the needle. It comes in a range of six different doses from the initial 2.5 milligrams up to the maximal dose of 15 milligrams. This drug has the similar GI side effects of nausea and diarrhea that is experienced with the other GLP-1 medications. The side effects can be reduced by slowly increasing the dose over time.
The downside is that this medication was approved before the final results of the large cardiovascular trial has been completed. This study has over 12,000 participants and will tell us if whether Mounjaro increases, decreases, or doesn’t change cardiovascular risk in people with diabetes. We know that Ozempic and Trulicity reduce this risk and until we get these results of this trial at the end of 2024, these GLP-1 agents may be better options to use in high-risk individuals.
The structure of Mounjaro is also quite different than the GLP-1 RA’s we currently have. It is based on the GIP molecule, not GLP-1, so there is a theoretical reason why it might behave differently in terms of cardiovascular events. There is also a black box warning that all the GLP-1 receptor agonists have in terms of the risk for medullary thyroid carcinoma, and it has the same exclusion for people who have a personal or family history of medullary thyroid carcinoma, or an eminent syndrome.
Little is known about the cost or insurance coverage of Mounjaro for people with type 2 diabetes. To date, the GLP-1 class of drugs has been priced on the high side and it is unknown if the dual GIP + GLP-1 will be priced even higher.
All-in-all, this is an exciting new option that should be available soon that could lead to a simplified treatment option with improved glucose control and a weight-loss benefit. We are looking forward to trying this new option in the right patients and eagerly await the results of the continuing weight-loss and cardiovascular trials.
For more on the approval of Mounjaro there are four videos on Medscape.
Dr. Peters has two videos that report on the Tirzepatide trial data:
Tirzepatide is the newest player in the quest for lowering A1c in people with type 2 diabetes. Dr Anne Peters describes the novel agent -- what it can do for patients now and in the future.
Dr Anne Peters discusses tirzepatide and the topline results from the SURPASS trials.
And Mark has two videos. One with a long-time weight-reduction researcher and other with a clinical trial investigator.
Weight management is the driver of all chronic diseases, contends Dr Donna Ryan, who discusses her extensive experience in researching obesity and her optimism for new medication advances.
Dr Juan Frias discusses results from the SURPASS trials and how tirzepatide might eventually be used in the clinical setting.