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In the landscape of medically-supervised treatments for weight management, Zepbound™ is redefining how healthcare providers are tackling obesity and associated health risks.
As the brand name for tirzepatide, Zepbound™ has garnered FDA approval for its efficacy in chronic weight management, standing out with its dual mechanism as a GIP and GLP-1 receptor agonist.
Originally introduced as Mounjaro® for type 2 diabetes, its weight loss benefits have paved the way for its repositioning in obesity treatment.
In this article, we will take a look at how Zepbound™ works, its FDA approval, the clinical trial backing and its administration and dosage.
Zepbound™ is a brand name for tirzepatide, an FDA-approved medication for chronic weight management. Tirzepatide has shown substantial weight loss benefits, leading to its approval under the name Zepbound™ for obesity and overweight treatment.
Tirzepatide is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist (agonists are compounds that imitate the effects of a neurotransmitter or hormone, eliciting a response upon binding to a particular receptor in the brain).
It is a single novel molecule that activates the body’s receptors for GIP and GLP-1, which are natural incretin hormones.
GIP is a hormone that may complement the effects of GLP-1 receptor agonism. It has been shown to decrease food intake while blunting the metabolic adaptive responses that usually occur with calorie restriction resulting in weight reductions.
When combined with GLP-1 receptor agonism, it can result in greater effects on markers of metabolic dysregulation such as body weight, glucose and lipids.
Tirzepatide was approved on November 8, 2023 as Zepbound™ for use in addition to a reduced calorie diet and increased physical activity.
This is an injection for chronic weight management in adults with obesity (body mass index of 30 kilograms per square meter (kg/ m2) or greater) or overweight (body mass index of 27 kg/m2 or greater) with at least one weight-related condition.
Weight related conditions include high blood pressure, type 2 diabetes or high cholesterol.
The approval of Zepbound™ was based on results from the SURMOUNT-1 and SURMOUNT-2 phase 3 trials, demonstrating significant weight loss over 72 weeks compared to placebo.
Clinical trials for tirzepatide have shown it significantly reduces HbA1c, fasting plasma glucose, and postprandial glucose levels, offering notable weight loss for individuals with type 2 diabetes. It’s an attractive treatment option for those needing control of both glycemic levels and weight.
The SURMOUNT-1 trial, focusing on non-diabetic individuals with obesity or overweight, showed that tirzepatide was superior to placebo in achieving body weight reduction.
Participants received tirzepatide in a step-wise manner, starting at 2.5 mg weekly and titrating up to maintenance doses of 5 mg, 10 mg, or 15 mg.
The SURMOUNT-2 trial, designed for adults with obesity or overweight and type 2 diabetes, compared the effectiveness and safety of tirzepatide (10 mg and 15 mg) to placebo. Participants, who were on a reduced-calorie diet and increased physical activity, were randomly assigned in equal ratios to either tirzepatide or placebo.
The treatment began with a 2.5 mg weekly dose of tirzepatide, gradually increasing to the maintenance doses of 10 mg or 15 mg. The primary goals were to demonstrate the superiority of tirzepatide in mean percentage body weight reduction from the baseline and in the percentage of participants achieving over 5% body weight loss at 72 weeks compared to placebo.
The FDA approval of Zepbound™ is based on the results of the SURMOUNT-1 and SURMOUNT-2 phase 3 clinical trials.
One of the more impressive highlights from these studies was that approximately one-third of subjects on the highest dosage of Zepbound™ experienced weight loss exceeding more than 25% of their body weight.
While Zepbound has shown promising results, it’s crucial to monitor patients for potential adverse events.
Known side effects include:
The most common adverse reactions were reported in ≥5% of patients treated with Zepbound™.
Zepbound™ has been found to induce thyroid C-cell tumors in rats, but it remains unclear if it has the same effect in humans, including causing medullary thyroid cancer.
Therefore, Zepbound™ is not recommended for individuals with a personal or familial history of medullary thyroid cancer or those diagnosed with Multiple Endocrine Neoplasia syndrome type 2.
Zepbound™ is administered via subcutaneous injection, with a recommended starting dosage of 2.5 mg once weekly, gradually increasing based on treatment response and tolerability.
Before starting Zepbound™ treatment, patients and caregivers must be trained on the correct injection technique, which can be found in the detailed Instructions for Use that come with illustrations.
The medication should be inspected for clarity and any discoloration or particles before use, administered weekly without regard to meals, and injected subcutaneously into the abdomen, thigh, or upper arm, ensuring the injection site is rotated with each dose.
Note: With any successful medically-supervised weight loss treatment program, diet and exercise are an equally important part of the equation.
Your patients can expect Zepbound™ to remain in their system for approximately 30 days after their last dose.
Most patients should expect to take Zepbound™ for just over one year. In some cases, it can be longer depending on the patient.
Sources say costs will vary for patients depending on their insurance plan, deductibles, medical history, etc. It’s possible their insurance will not fully or even partially cover the cost of the drug for them. Patients should check with their insurance company to confirm.
That being said, the drug could cost as little as $25/month according to Eli Lilly if patients enrol in a commercial card savings program or $550/month for patients with insurance that doesn’t cover the drug.
Without any assistance, the estimated cost of Zebpound is around $1,113 per month.
No. There is currently no generic form of Zepbound™.
Interested physicians can enhance their expertise in using Zepbound™ by signing up for the Certified Medical Weight Management Provider™ (CWMP) program.
The Certified Medical Weight Management Provider™ (CWMP) program is a comprehensive training initiative designed to empower healthcare professionals with the knowledge and tools to offer effective weight loss solutions. Key benefits of the program include:
This program stands out as an all-in-one solution, aimed at equipping medical professionals with the necessary skills to effectively manage and treat weight issues, ultimately leading to improved patient outcomes.
This program stands out as an all-in-one solution, aimed at equipping medical professionals with the necessary skills to effectively manage and treat weight issues, ultimately leading to improved patient outcomes.
The future of Zepbound™ in weight management appears promising and poised for growth. As a significant advancement in medically-supervised weight loss, Zepbound has already demonstrated its ability to facilitate substantial reductions in weight through clinical trials.
This efficacy marks it as a potent tool against obesity, a condition that plagues a substantial portion of the population and is associated with numerous health complications.
Looking ahead, ongoing studies are set to provide more insights into the long-term efficacy and safety of Zepbound™.
These studies will likely explore the drug’s impact on various obesity-related comorbidities, such as cardiovascular disease, non-alcoholic fatty liver disease, and sleep apnea, potentially broadening its therapeutic scope.
Moreover, research into the psychosocial benefits of weight loss facilitated by Zepbound™ could offer a deeper understanding of its influence on quality of life, mental health, and socio-economic factors.
Additionally, as health care providers become more familiar with Zepbound™ through programs like the Certified Medical Weight Management Provider™ (CWMP), its integration into treatment protocols may increase, enhancing patient access to this cutting-edge therapy.
With continued research and educational efforts to increase its adoption among healthcare providers, Zepbound™ is well-positioned to become a mainstay in obesity management.
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Mounjaro® and Zepbound™ are registered trademarks of Eli Lilly.
