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FDA-Approved Version of Mounjaro (tirzepatide peptide) Treats Obesity

Dec 19, 2023
FDA-Approved Version of Mounjaro (tirzepatide peptide) Treats Obesity

As the field of weight management continues to advance, a recent announcement that the U.S. Food and Drug Administration (FDA) has approved Zepbound (tirzepatide peptide), a form of the diabetes drug Mounjaro for weight loss, is met with excitement. The tirzepatide clinical trial results for treating obesity are extremely promising, with some participants losing up to 24% (60 pounds) of their body weight.1

Manufactured by Eli Lilly and Co., Zepbound is the latest addition to the family of type 2 diabetes/obesity medications, with its active ingredient, tirzepatide, a synthetic peptide already approved under the brand name Mounjaro for type 2 diabetes. This approval marks a significant milestone in the battle against obesity. This condition affects over half of the U.S. adult population.

The Prevalence and Impact of Obesity

Obesity and overweight have reached alarming levels in the United States, with approximately 42% of U.S. adults living with obesity.

Obesity is a chronic, relapsing disease that increases the risk of developing nearly 200 other serious health issues, such as heart disease, stroke, type 2 diabetes, and high cholesterol.

The FDA’s decision to approve Zepbound addresses the urgent need for effective treatments to combat the rising rates of obesity and overweight and mitigate their associated health risks.

Understanding Tirzepatide Peptide: A Dual-Acting Weight Loss Medication

Tirzepatide belongs to a class of drugs known as incretin mimetics, which mimic the action of hormones released by the gut in response to food. These hormones, namely glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) play crucial roles in regulating blood sugar levels, slowing stomach emptying, and reducing food cravings.

By targeting both GLP-1 and GIP receptors, tirzepatide effectively reduces appetite, food cravings, and food intake, aiding in weight loss.

clinical trials

The Efficacy of Tirzepatide Peptide: Clinical Trial Results

Extensive clinical trials have demonstrated the remarkable efficacy of tirzepatide in treating obesity. In a series of randomized, double-masked, placebo-controlled trials involving over 2,500 patients, participants taking tirzepatide consistently lost more weight than those taking a placebo.

Patients who received tirzepatide, along with a reduced-calorie diet and exercise plan, experienced substantial weight loss, with some individuals achieving a reduction of up to 24% of their body weight.1

Long-term clinical studies show that people continue to lose weight while taking tirzepatide. However, they also indicate that weight regain is likely once you stop taking tirzepatide. This underlines the importance of making tirzepatide part of a comprehensive weight-loss program.

Safety Considerations and Possible Side Effects

As with any medication, tirzepatide comes with potential side effects.

Some common side effects include nausea, diarrhea, vomiting, constipation, and abdominal discomfort. These side effects are typically rated as mild-to-moderate in intensity. They usually improve over time and can be worse with dosage increases. About 10% of participants in the tirzepatide clinical trials discontinued treatment due to side effects.

Potentially serious complications can also occur, including gallbladder disease, allergic reactions, thyroid cancer, low blood sugar, injection site reactions, inflammation of the pancreas, and intestinal blockage.

Tirzepatide carries a box warning about the risk of thyroid C-cell tumors. In animal studies, tirzepatide was linked to an increased risk of thyroid tumors. However, it is not clear if the same risk is found in people. People with a personal or family history of thyroid tumors should not take tirzepatide.

weight loss

Target Population: Who Can Benefit from Taking Tirzepatide Peptide?

The FDA has approved Zepbound (tirzepatide) for individuals who meet the following criteria:

  • Obesity, with a body mass index (BMI) of 30 or higher
  • Overweight, with a BMI of 27 or higher, and at least one weight-related condition such as high blood pressure, high cholesterol, or type 2 diabetes.

Tirzepatide should be used along with a reduced-calorie diet and increased physical activity. The FDA says that tirzepatide is not a stand-alone solution. By consuming a reduced-calorie diet and making physical activity a regular part of your daily schedule, you can maximize its weight-loss benefits. Consume a diet high in protein and fiber and low in highly processed and high-glycemic foods to reduce glucose spikes and cravings.

Many people have tried reduced-calorie diets in the past and were unsuccessful in losing any significant amount of weight. They describe “food noise” and cravings as critical factors that make dietary methods of weight loss almost impossible. Food noise is not a medical term. Some people experience a constant noise in their brain that drives them to think about food all day, whether they are hungry or not.

Many people who have taken tirzepatide report that medications in this class, such as tirzepatide and semaglutide, quiet food noise and make it possible to adhere to a healthy diet.

Pricing and Accessibility

While the approval of Zepbound brings hope to many individuals struggling with obesity, it is essential to address the issue of accessibility. The list price of Zepbound is $1,059.87 per month, which will pose financial challenges for many patients, especially those who lack insurance coverage for the medication.

Explore insurance coverage options. For example, Eli Lilly offers a medication savings card for people with certain types of insurance to receive coverage at a discounted price. Government beneficiaries are excluded. If you qualify for a savings card, you may pay as little as $25.00 for a 1- or 3-month prescription. Card savings are a maximum of $150 per month.

Tirzepatide peptide was synthesized in research labs

The Future of Weight Management: A Paradigm Shift

The approval of Zepbound signifies a significant shift in the approach to weight management. Traditionally, weight loss has been a challenging endeavor, with limited pharmaceutical options available. However, with the introduction of Zepbound and other weight loss medications, such as Wegovy and Saxenda, healthcare providers now have additional tools to address obesity and overweight as chronic medical conditions.

Talk to an Invigor Medical treatment specialist to learn more about our Weight Loss Treatment Plans.

FDA-Approved Version of Mounjaro (tirzepatide peptide) Treats Obesity
Disclaimer
While we strive to always provide accurate, current, and safe advice in all of our articles and guides, it’s important to stress that they are no substitute for medical advice from a doctor or healthcare provider. You should always consult a practicing professional who can diagnose your specific case. The content we’ve included in this guide is merely meant to be informational and does not constitute medical advice.

FDA-Approved Version of Mounjaro (tirzepatide peptide) Treats Obesity

Leann Poston, M.D.

Dr. Leann Poston is a licensed physician in the state of Ohio who holds an M.B.A. and an M. Ed. She is a full-time medical communications writer and educator who writes and researches for Invigor Medical. Dr. Poston lives in the Midwest with her family. She enjoys traveling and hiking. She is an avid technology aficionado and loves trying new things.

References

  • 1. Wadden TA, Chao AM, Machineni S, Kushner R, Ard J, Srivastava G, Halpern B, Zhang S, Chen J, Bunck MC, Ahmad NN, Forrester T. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nature Medicine. 2023.

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