As the pursuit of effective weight management solutions intensifies, Mounjaro (tirzepatide) has emerged as a noteworthy contender. While initially approved by the Food and Drug Administration (FDA) for treating type 2 diabetes, Mounjaro has garnered attention for its potential off-label use in promoting weight loss. This article delves into the intricacies of Mounjaro, examining its effectiveness, usage, side effects, and overall role in the evolving landscape of weight loss medications.
Understanding Mounjaro and Tirzepatide
Mounjaro is a brand-name subcutaneous injection pen containing tirzepatide. Tirzepatide is a dual incretin medication, attaching to two different receptors. It is a new class of medication for the treatment of diabetes. Tirzepatide is unique in the sense that is a dual incretin medication. It attaches to two different receptors. So we have a class of medication that has been in the market now for about 15 years called GLP-1 receptor agonist. The drug mimics the activity of the hormones GIP and GLP-1. These hormones are released in response to us eating food. When we eat carbs or sugar, it goes in our stomach and then reaches our stomach and our intestines, our gut. Our body says, "Whoa, we got nutrients here." We release the GLP-1 and this other one called GIP hormones that then say, "We got food, we got carbs, we got sugar. Let's tell our pancreas to release insulin," because we just got some food in our body. We got some sugar in our body. And then it crosses the brain and tells the appetite centers in my brain that, "I just got nutrients. The issue with our natural hormones in our body is that they get taken down, they get broken down very quickly. They only last a few seconds. Therefore, that's why they're so effective. And therefore, that's why they are also given once a week, which is really kind of neat for a lot of those medications. So you don't have to take a medication every day.
Another version of tirzepatide, known as Zepbound, has received FDA approval for weight loss in adults with obesity or who are overweight and have at least one weight-related condition, such as high blood pressure or heart disease.
Off-Label Use of Mounjaro for Weight Loss
The use of Mounjaro for weight loss is considered an off-label use. Off-label drug use is when a medication the FDA approved is prescribed for a purpose other than what it’s approved for. Mounjaro may be prescribed off-label for weight loss in adults with or without type 2 diabetes. In addition, it may be used off-label in adults who:
- Have obesity
- Are overweight and have at least one health condition related to weight, such as high cholesterol, high blood pressure, or sleep apnea
It's important to note that insurance providers may not cover Mounjaro for off-label uses.
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How Mounjaro Works
Mounjaro belongs to two groups of drugs called GIPs and GLP-1s. It works by mimicking the activity of the hormones GIP and GLP-1. Mounjaro works to treat type 2 diabetes in several ways:
- Increases the amount of insulin your body makes after eating
- Reduces the amount of glucose (sugar) released into your blood and also helps remove excess glucose from your blood
- Slows the movement of food through your stomach, which helps prevent your blood sugar from spiking after eating
Mounjaro also reduces your appetite, which can help you consume fewer calories, potentially leading to weight loss.
Clinical Evidence for Weight Loss
Clinical trials of Mounjaro for treating type 2 diabetes looked at the drug’s effect on body weight. Many people who used the drug for type 2 diabetes did lose weight. A separate clinical trial looked at the use of Mounjaro for weight loss in people without diabetes. The trial included adults who either:
- Have obesity
- Are overweight and have at least one health condition related to weight, such as high cholesterol, high blood pressure, or sleep apnea
Most adults in this trial lost at least 10% of their body weight after using Mounjaro for 72 weeks (about 18 months).
One study compared Mounjaro with Ozempic for treating type 2 diabetes. While this study wasn’t done specifically to look at weight loss, researchers did look at the effect of both drugs on body weight. They found that people who used Mounjaro to treat type 2 diabetes lost more weight than people who used Ozempic for this purpose.
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According to a study published in JAMA Internal Medicine, individuals taking Mounjaro were three times as likely to lose 15% or more of total body weight, 2.5 times as likely to experience 10% or more weight loss, and 1.8 times as likely to experience 5% or more weight loss compared to those taking semaglutide, the active ingredient found in Ozempic. This finding was sustained at 12 months of follow-up.
Dosage and Administration
The usual starting dosage of Mounjaro for weight loss is 2.5 milligrams (mg) once per week for 4 weeks. After that, your doctor may increase your dose by 2.5 mg. They may continue to increase your dose by 2.5 mg every 4 weeks. The maximum dosage they’ll prescribe is 15 mg of Mounjaro once per week.
Mounjaro comes as a liquid solution in a single-use injection pen. It’s given as a subcutaneous injection. You’ll inject Mounjaro under the skin of your abdomen or thigh. A caregiver can also give you an injection under the skin of your upper arm. You can inject the drug at any time of day, but try to inject it on the same day each week.
Potential Side Effects
The off-label use of Mounjaro for weight loss may cause side effects that are mild or serious.
Mild Side Effects
- Injection site reactions
- Slight increase in heart rate
- Mild problems with digestion, such as abdominal pain, constipation, diarrhea, indigestion, loss of appetite, nausea, vomiting
Serious Side Effects
- Severe problems with digestion, such as severe diarrhea, nausea, or vomiting, which may lead to dehydration and kidney problems
- Acute pancreatitis (sudden inflammation of the pancreas)
- Hypoglycemia (low blood sugar)
- Acute (sudden) gallbladder disease, which may include gallstones or cholecystitis (inflammation of the gallbladder)
- Risk of thyroid cancer
- Allergic reaction
Boxed Warning: Risk of Thyroid Cancer
Mounjaro has a boxed warning about the possible risk of thyroid cancer. This is a serious warning from the FDA. Animal trials have shown an increased risk of thyroid cancer with the use of tirzepatide (the active ingredient in Mounjaro). It’s not known for certain if the use of Mounjaro increases the human risk of thyroid cancer.
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Doctors likely will not prescribe Mounjaro for people with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
Important Considerations Before Using Mounjaro
Before using Mounjaro off-label for weight loss, it's crucial to consider certain factors. The drug may not be a safe option if you have certain medical conditions or other factors that affect your health. These include:
- Problems with your digestive system, such as gastroparesis (stomach paralysis)
- An upcoming medical procedure that may require general anesthesia
- A kidney problem, such as kidney failure
- A history of pancreatitis
- Diabetic retinopathy
- Pregnancy or breastfeeding
- A previous allergic reaction to Mounjaro or any of its ingredients
Mounjaro vs. Ozempic
Both Mounjaro and Ozempic are approved to treat type 2 diabetes and can be prescribed off-label for weight loss. Studies have not specifically compared Mounjaro with Ozempic when they’re used for weight loss. However, one study did compare the effects of Mounjaro and Ozempic on body weight when used to treat type 2 diabetes. In this study, people using Mounjaro lost more weight than people using Ozempic.
Long-Term Use and Weight Maintenance
A long-term study of tirzepatide for weight loss looked at the effects of stopping treatment. One year after the drug was stopped, most people had regained some of the weight they’d lost. In contrast, most people who continued using tirzepatide long term had maintained their weight loss. In some cases, they experienced additional weight loss over time. Based on these results, your doctor will likely recommend long-term use of Mounjaro to help maintain weight loss.
Cost and Availability
The price of Mounjaro depends on several factors, including your treatment plan, your health insurance coverage (if you have it), and the pharmacy you use. Mounjaro’s price may be different for an off-label use than for an approved use. For example, some health insurance plans may not cover Mounjaro when it’s prescribed off-label for weight loss.
Integrating Lifestyle Changes
Medical specialists emphasize that using medication to lose weight also requires cardio and strength training and changing your diet to one that includes proteins and less processed foods with added sugars.
A Realistic Timeline for Weight Loss with Mounjaro
Weight loss doesn’t happen overnight, and it could take up to 18 months to get the results you’re looking for from Mounjaro. You can expect to lose 6% of your body weight after two months, 9% after three months, and 11% after four months. By the 18-month mark, Mounjaro patients experience around 21% weight loss.
User Reviews and Experiences
User-generated content on platforms like WebMD can provide insights into real-world experiences with Mounjaro. However, it's important to note that these opinions are solely those of the user and may not represent the opinions of WebMD or medical professionals.
Some users have reported positive experiences with Mounjaro, noting significant weight loss and improved appetite control. However, others have reported negative side effects, such as diarrhea, nausea, and constipation.