A Guide to Zepbound™, Approved by the FDA for Weight Loss
If you are struggling to lose weight through diet and exercise alone, new prescription weight loss medications, like Zepbound™ that was just approved by the FDA, may be an option for you.
What is Zepbound™ and how does it work?
Zepbound™ is tirzepatide, a prescription medication manufactured by Eli Lilly. Tirzepatide is already on the market, sold under the brand name Mounjaro and approved for the treatment of diabetes. Taken once a week via injection, it has just been approved by the FDA for weight loss under the brand name Zepbound™.
Tirzepatide mimics two naturally occurring hormones called glucagon-like peptide-1, abbreviated GLP-1, and glucose-dependent insulinotropic polypeptide, abbreviated GIP. These hormones act on several systems to decrease appetite by producing feelings of fullness. They also affect the appetite centers of the brain and slow down how quickly the stomach empties, which leaves you feeling full for longer. Additionally they act on the pancreas to increase insulin secretion and decrease glucagon. (This reduces blood sugar levels, after you eat.) Another way they work is converting white fat-storing cells into brown fat, which increases energy expenditure.
Tirzepatide is similar to another medication called semaglutide, sold under the brand names Ozempic and Wegovy, which are in the GLP-1 class of drugs.
Why is Zepbound™ important?
The data from Zepbound™ studies shows that patients can lose 15% to nearly 21% of their body weight, depending on the dosage. This is good news because obesity is a medical condition, not a matter of personal choice. Defined simply as a person’s body accumulating and storing excess body fat, obesity is influenced by a multifaceted interplay of genetics, environment, and other factors. Research has revealed that obesity has an impact on 236 other diseases, including 13 types of cancer.
Biological factors including genetics and other health conditions can make weight loss difficult. The environment around us can also play a big role in weight loss. These new GLP-1 and GIP weight loss medications, like Ozempic and Zepbound™, fight against these genetic, biological, and environmental factors that prevent weight loss.
Even with medications, it’s important to eat healthy and exercise regularly. Consuming healthy foods and drinks, along with getting regular physical exercise, may help you reach and maintain a healthy weight. Maintaining a healthy weight, getting adequate sleep, and managing stress may also help reduce risk for some health conditions like type 2 diabetes and heart disease.
Obesity facts
- Obesity is the most common chronic disease in the United States. According to the CDC, about 93.3 million U.S. adults were affected by obesity from 2015–2016.
- Obesity costs the United States $1.42 trillion annually, using 14.3% of healthcare spending dollars and causing 320,000 deaths.
- Losing just 5% body weight can save an individual with a BMI over 40 $2,137 per year.
- Within 15 years, 50% of the U.S. adult population will suffer from obesity.
- Lifespan is shortened by up to 8 years for those with a BMI greater than 40, which is comparable to the effects of smoking.
Road to approval
The FDA approved tirzepatide for the treatment of type 2 diabetes in May 2022. Marketed under the brand name Mounjaro, it works as a glucose-lowering therapy. In the clinical trials for Mounjaro, called SURMOUNT-1, not only did participants see positive responses to their diabetes management, those on a 15mg dose of tirzepatide experienced an astonishing 22.5% reduction in body weight. This immediately caught the eye of researchers and clinicians alike.
The manufacturer, Eli Lilly, announced on Oct. 6 2022 that the FDA granted tirzepatide a “fast track” review to be designated as a treatment for obesity. To receive this label, Lilly used data from the SURMOUNT-1 trial and the ongoing SURMOUNT-2 trial, which is investigating tirzepatide in people with type 2 diabetes who have excess weight or obesity.
The FDA grants these fast-track designations to medications that 1) treat serious or life-threatening conditions; and 2) demonstrate the potential to address unmetunment medical needs. With the rising rates of the serious conditions of adult and childhood obesity, coupled with the limited options for medical treatment, tirzepatide could be a game-changer in the obesity epidemic.
In the SURMOUNT-1 clinical trial the average weight loss after 72 weeks was 15% for the 5mg dose, 19.5% for the 10mg dose and 20.9% for the 15mg dose. Currently, one of the best glucose-lowering medications for weight management is Wegovy (semaglutide), which resulted in a 14.9% reduction in body weight — significantly lower than tirzepatide’s 22.5% reduction.
Zepbound™ cautions, side effects, and safety warnings
Warnings for Zepbound™ include that the drug may cause tumors in the thyroid, including thyroid cancer and should not be used if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound™.
Zepbound™ also has a number of indicated side effects, some serious, that should be considered carefully and reviewed with your provider before starting. These side effects may include severe stomach problems, and can come with some uncomfortable gastrointestinal side effects such as nausea, vomiting, abdominal discomfort, bloating, gassiness, constipation and diarrhea, kidney, gallbladder and pancreatic problems, and serious allergic reactions in some individuals. Often, side effects are short-term and improve as your body adjusts to the medication. Not everyone will experience side effects. It’s important to check with your provider for guidance on how to manage any side effects you may experience.
Zepbound™ cautions
One possible consideration with any prescription weight loss medication, including Zepbound™, is that you may stop losing weight if you stop taking your medication, potentially leading to weight cycling. Weight cycling refers to repeatedly losing and regaining weight. Studies have linked weight cycling to a greater risk of diabetes, hypertension and gallbladder stones. Patients beginning prescription medication for weight loss or weight management are often advised to consider a holistic approach to comprehensive lifestyle change in order to reduce the risk of weight cycling.
A third issue with Zepbound™ and other new injectable weight loss medications is how expensive they are. Ozempic, for example, comes in at about $1,400 a month out of pocket when not covered by insurance — which is high enough that many people can’t afford to stay on the medication for the long term. Unfortunately, many insurance companies don’t cover newer weight loss drugs, even when medically necessary (more about this). If you want to use your insurance plan to cover treatment, find a copy of your insurance company’s drug formulary to see what medications are covered. With this information, you and your provider can create a treatment plan that fits your needs.
Zepbound™ and other weight loss medications
There are different categories of prescription medications to support weight loss. Every body is different, so your provider may prescribe medication depending on your desired results, side effects, and health condition. Zepbound™ and Mounjaro are the same active ingredient, just approved for different medical conditions — Zepbound™ for obesity and Mounjaro for diabetes.
There are a variety of options in addition to tirzepatide. Learn more about the most commonly prescribed, and how to decode acronyms like GLP-1, GIP, and more.
Is Zepbound™ right for me?
As these new treatments for obesity have demonstrated effectiveness when used appropriately, the demand for prescription weight loss medication has significantly increased in the past year, thanks to celebrity endorsements, medical professionals’ willingness to prescribe the medication, and coupon programs that reduce its cost, at least initially. As a result, drug companies are struggling to meet the demand. However, it is certain that new treatments for obesity have proven to be effective when used appropriately. If you are living with obesity, consult with a medical professional to determine whether you are a suitable candidate.
About Hello Alpha
Hello Alpha is a nationwide virtual primary care platform specializing in women’s health. While we treat all genders, Alpha focuses on women of all ages, delivering whole person care optimized for their unique behavioral and physical needs.
If you’re interested in being screened for weight loss or want to learn about prescription weight loss medication, you can start a visit with Hello Alpha at any time. Our dedicated providers can help you get holistic, personalized care throughout your healthcare journey.
If you’re interested in learning more, browse our other blog posts about prescription weight loss treatment:
Dear Dr. J: What Should I Know About Weight Loss Medication?
PLEASE NOTE: THIS BLOG DOES NOT PROVIDE MEDICAL ADVICE.
The information, including but not limited to, test, graphics, imagines and other material contained on this website are for informational/educational purposes only. No material on this site is intended to substitute for professional medical advice, diagnosis or treatment. A patient-client relationship will only be formed after you enter into a written agreement with an Alpha provider. Always consult a professional in the area for your particular needs before undertaking any new healthcare regimen.
Sources:
- https://www.fda.gov/drugs/development-approval-process-drugs
- https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
- https://www.drugs.com/mounjaro.html
- Milken Institute Report. http://www.milkeninstitute.org/publications/view/833. Accessed April 30, 2017
- Alexander LC. https://obesitymedicine.org/diseases-related-to-obesity/. Accessed October 8, 2018
- https://www.nejm.org/doi/full/10.1056/NEJMoa2206038
- https://obesitymedicine.org/what-is-obesity/
