From the Guidelines
Mounjaro (tirzepatide) is not FDA approved for weight loss or hyperlipidemia, but it is approved for type 2 diabetes management, and its counterpart, Zepbound, is FDA approved for chronic weight management in adults with obesity or overweight with at least one weight-related condition, as of November 2023, as reported in a review of obesity management in adults 1. The medication, tirzepatide, has been shown to have a significant impact on weight loss, with a mean weight loss of 20.9% for the 15 mg dose, 19.5% for the 10 mg dose, and 15.0% for the 5 mg dose, compared to 3.1% for placebo, in a randomized controlled trial (RCT) of 2539 adults with obesity and without diabetes 1. Some key points to consider when prescribing tirzepatide for weight management include:
- The FDA-approved indication for Zepbound, which contains the same active ingredient as Mounjaro, is for chronic weight management in adults with obesity or overweight with at least one weight-related condition.
- The typical starting dose for Zepbound is 2.5 mg weekly by subcutaneous injection, with gradual dose increases up to 15 mg weekly as tolerated.
- Common side effects of tirzepatide include nausea, diarrhea, vomiting, and constipation, which often improve over time.
- While tirzepatide is not FDA approved for hyperlipidemia, clinical trials have shown improvements in lipid profiles as a secondary benefit, as noted in the review of obesity management in adults 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Mounjaro FDA Approval
- Mounjaro (tirzepatide) is approved in the United States as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes 2, 3, 4.
- The FDA approval is based on the results of the SURPASS clinical trials, which demonstrated the efficacy and safety of tirzepatide in improving glycemic control and reducing body weight in adults with type 2 diabetes 2, 3, 4.
Weight Loss and Hyperlipidemia
- Tirzepatide has been shown to result in significant weight loss in clinical trials, with reductions in body weight ranging from 6.2 to 19.7 kg 2, 5, 6.
- The SURMOUNT-1 trial demonstrated that tirzepatide resulted in substantial and sustained weight reduction over a 3-year period, with a mean percent change in body weight of -12.3% to -19.7% compared to -1.3% with placebo 5.
- Tirzepatide has also been shown to reduce parameters associated with heightened cardiometabolic risk, including blood pressure, visceral adiposity, and circulating triglycerides 2.
FDA Approval for Weight Loss and Hyperlipidemia
- While tirzepatide is approved for the treatment of type 2 diabetes, it is not specifically approved for weight loss or hyperlipidemia 2, 3, 4.
- However, the results of clinical trials suggest that tirzepatide may be effective in reducing body weight and improving cardiometabolic risk factors, and it is being investigated for use in chronic weight management and other conditions 2, 5.