Can you take Mounjaro for prediabetes and weight loss? Has the FDA approved Tirzepatide for prediabetes and weight loss?
The last time I searched the FDA site I couldn’t find any such indication. Although, I have heard that Eli Lilly has submitted it for FDA approval as a weight loss drug for obese people without diabetes.
There is sufficient evidence now and Mounjaro may soon get approval for weight loss and preventing the onset of type 2 diabetes especially in overweight and obese individuals.
Mounjaro for Prediabetes:
Mounjaro (Tirzepatide) has dual actions. It acts as a GLP-1 analog similar to Ozempic. It also enhances the release of glucagon.
As per the ADA 2023 guidelines and recommendations, Mounjaro is the most potent medicine to treat diabetes.
|Diabetes Medicines that are ‘High to very highly effective||GLP-1 Receptor agonists||
|Diabetes medicines that are the most potent||GIP and GLP-1 Receptor agonists||
Prediabetes is a state of impaired blood glucose. It is like the body is warning you to change your habits or you are going to become diabetic.
Prediabetes is defined as:
- Fasting blood glucose: 100 to 125 mg/dl
- 2 hours post-meal glucose: 140 to 199 mg/ dl
- A1C: 5.7 to 6.4%
A post hoc analysis of the SURMOUNT-1 clinical trial evaluated the impact of Mounjaro on the 10-year risk of developing type 2 diabetes in individuals who were obese or overweight with or without prediabetes.
The results of the analysis are summarized in the table below:
Participants with Prediabetes
Participants without Prediabetes
|Baseline 10-Year Risk||29-32%||19-20%|
|Absolute Reduction at Week 72||TZP 5/10/15 mg: 16-20%||TZP 5/10/15 mg: 10-11%|
|Change vs. Placebo at Week 72||TZP 5 mg: -13%||TZP 5 mg: -11%|
|TZP 10 mg: -17%||TZP 10 mg: -12%|
|TZP 15 mg: -18%||TZP 15 mg: -12%|
It is evident from the table above that Mounjaro significantly reduced the risk of type 2 diabetes in obese and overweight individuals who had prediabetes.
The risk was also significantly reduced in those who did not have prediabetes.
Another indirect evidence suggesting the role of using Mounjaro for prediabetes is the effect of Mounjaro on fasting insulin levels.
Compared to normal individuals, prediabetics have high fasting insulin levels.
Tirzepatide reduced the fasting insulin levels by 42 mIU/L compared to only 6.6 mIU/L (estimated mean difference of -38.9 mIU/L) [Ref].
Although Mounjaro is effective in lowering the A1C and treating prediabetes, the primary treatment of prediabetes is sticking to a healthy diet and exercise routine.
In summary, Mounjaro delays the progression of developing type 2 diabetes, however, it has not been approved by the FDA for treating prediabetes.
Mounjaro for Weight Loss:
Mounjaro is associated with significant weight loss. The weight loss effects of Mounjaro in non-diabetic individuals have been studied in obese and overweight individuals.
The SURMOUNT-1 study published in NEJM included more than 2,500 patients who were either obese (BMI of more than 30 kg/m2) or overweight (BMI of more than 27 kg/m2) with at least one weight-associated medical condition other than diabetes.
Tirzepatide resulted in a weight loss ranging from 15% to 21% as summarized in the table below:
≥ 5% Weight Loss
≥ 20% Weight Loss
In the study, over half of the participants achieved a weight loss of 20% or more of their baseline weight when they received Mounjaro (Tirzepatide) at a dosage of 10 mg or higher.
Due to the significant weight loss observed with Tirzepatide, the manufacturers are optimistic about obtaining FDA approval for its use in weight management.
The SURMOUNT-2 clinical trial was conducted on obese diabetic individuals. The weight loss effects of Tirzepatide 10 mg and 15 mg are compared in both studies here:
|Tirzepatide 10 mg||SURMOUNT-1||SURMOUNT-2|
|% Weight Loss||-19.5.0%||-12.8%|
|≥ 5% Weight Loss||89%||79%|
The weight loss effects of Tirzepatide at its maximum dose of 15 mg are tabulated here:
|Tirzepatide 15 mg||SURMOUNT-1||SURMOUNT-2|
|% Weight Loss||-20.9.0%||-14.7%|
|≥ 5% Weight Loss||91%||83%|
The SURMOUNT 3 and 4 studies were conducted in obese individuals. The studies have not been published but results are available on the official website of Eli Lilly.
The results are summarized here:
|% Weight Loss||-24.5%||-21.4%|
|≥ 5% Weight Loss||94.4%|
The doses of Tirzepatide were not fixed. A dose of 2.5 mg was initiated and titrated upwards to the maximum tolerated doses of up to 15 mg.
Mounjaro for Prediabetes and Weight Loss:
There has been direct evidence that Mounjaro can reduce your risk of developing type 2 diabetes by 16 to 20% in the coming 10 years if you have diabetes and 10 to 11% if you don’t have prediabetes.
Other theoretical benefits of Mounjaro for prediabetes are because of its weight loss effects.
According to the CDC, a weight loss of just 5 to 7% can reduce your risk of developing Type 2 diabetes significantly.
The CDC is also running a healthy weight loss program (National Diabetes Prevention Program) where they have been successful in preventing type 2 diabetes by as much as 58% to 71% (if the age is more than 60 years).
Because the impact of weight loss on diabetes prevention is very significant, it is one of the primary goals to prevent prediabetes and diabetes.
Mounjaro is associated with a weight loss of up to 24% which is 3 to 5 times more than what the CDC recommends (5 to 7% weight loss).
Hence, there is a significant potential for Mounjaro to be used in obese individuals with prediabetes.