Mounjaro, known generically as Tirzepatide, is a medication used primarily for the treatment of type 2 diabetes in adults. It is developed and manufactured by Eli Lilly and Company, was FDA-approved on May 13, 2022, specifically for improving blood sugar levels in adults with type 2 diabetes. The comprehensive data from its clinical trials and the specific focus on its primary use and side effects make Mounjaro an important addition to diabetes management strategies. Here we will see some of the important points related to this medication.
Uses and Indications
- Primary Use: Mounjaro is used to improve blood sugar control in adults with type 2 diabetes mellitus. It should be used alongside a proper diet and exercise regimen.
- Weight Loss: Clinical trials for a 15 mg dose of Mounjaro showed significant weight loss in patients. However, for weight loss purposes, the same active ingredient (tirzepatide) is marketed under the brand name Zepbound, which is FDA-approved for weight loss.
Mounjaro - Newly approved medication for Type 2 Diabetes Treatment
Mounjaro works by helping the pancreas produce more insulin, reducing the amount of sugar produced by the liver, and slowing down food passage through the body. This results in patients feeling fuller for longer periods. It is the first medication to act on both glucose-dependent insulinotropic polypeptide (GIP) receptors and glucagon-like peptide-1 (GLP-1) receptors, both of which are incretin hormones that help regulate blood sugar levels.
- Formulation: Mounjaro is an injectable drug, available in a prefilled pen.
- Dosage: It is administered once weekly through subcutaneous injection in the abdomen, thigh, or upper arm. It can be used alone or in combination with other FDA-approved diabetes medications such as metformin, sulfonylureas, and insulin.
Clinical Trials and Efficacy
- Clinical Trials: The FDA's approval of Mounjaro was based on evidence from nine clinical trials involving 7,769 patients with type 2 diabetes. These trials were conducted at 673 sites in 24 countries.
- Efficacy: The drug has been shown to significantly lower HbA1c levels, a key measure of blood sugar control. In the clinical trials, Mounjaro was used as monotherapy or in combination with other antidiabetic medications, showing a substantial reduction in HbA1c levels compared to placebos and other diabetes treatments like semaglutide and insulin.
Effectiveness Across Demographics
In clinical trials, Mounjaro demonstrated similar effectiveness in controlling blood sugar across different sexes, races, and age groups, including patients younger than 65 and those 65 years and older. More on FDA official website.
- Common Side Effects: These include nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
- Serious Side Effects: These can include symptoms of an allergic reaction, pancreatitis, severe stomach problems, vision changes, symptoms of a thyroid tumor, gallbladder problems, low blood sugar symptoms, and kidney problems.
- Thyroid Tumor Warning: There is a warning regarding thyroid tumor symptoms, as studies in rats showed that tirzepatide caused thyroid tumors, including thyroid cancer. It is not recommended for use in patients with a personal or family history of certain types of thyroid cancer or endocrine conditions like Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).