Zepbound® (tirzepatide / marketed as Mounjaro® for diabetes)

Zepbound is a once-weekly injectable medication that has was approved by the FDA for chronic weight management on November 8th, 2023, and is now available at U.S. retail pharmacies. The mechanism of action is similar to Wegovy in that it is a gut hormone analogue. Wegovy is a GLP-1 analogue, while Zepbound is a dual-hormone analogue, having activity at both GIP (glucose dependent insulinotropic peptide) and GLP-1 (glucagon-like peptide 1). In a study published in the New England Journal of Medicine of 2,539 people, patients lost an average of 20.9% of their starting body weight (~50 pounds!) after treatment with Zepbound 15 mg weekly for 72 weeks.

The first step in getting on Zepbound is checking with your health insurance company to see if you have coverage. In addition, there is a coupon to lower the cost available from Lilly – read more about their savings program here.

If you are interested in starting Zepbound schedule a visit with a CNC provider. Read more about Zepbound at Lilly’s website here.

Lilly takes a stand against the use of Zepbound and Mounjaro for cosmetic weight loss

Airing during the Academy Awards, Lilly stated that its medications are to improve the health of people living with obesity, and took a stab at people using these medications for purely cosmetic results, including many Hollywood celebrities.

How to use a Zepbound Pen

Wegovy (semaglutide)

Semaglutide is the active ingredient in Wegovy, Ozempic, and Rybelsus, Originally studied for type 2 diabetes, it was initially approved for this indication. In 2021, it was approved for chronic weight management and named Wegovy.

Wegovy contains a higher dose (2.4 mg) of semaglutide than Ozempic (.5 mg, 1 mg, or 2 mg). It is self-administered as an injection once weekly and provides better weight loss than the oral medications. The average weight loss for patients treated with Wegovy is 15-16% weight loss at 1 year, or 35 pounds, although in our clinical experience, it is not unusual for patients to lose far more than this when combined with one of CNC’s intensive programs.

Semaglutide mimics the effects of a hormone the human body makes called GLP-1. This hormone is released by our gut when we eat, and not only lowers blood sugar, but also signals the brain that we have just eaten –> that we are satisfied. Patients treated with Wegovy find their hunger and cravings go away and are often replaced with a desire to eat healthier options. It is not a stimulant, so doesn’t keep you awake at night. Side effects include nausea, diarrhea, constipation, and fatigue (among others – see Wegovy web site here), but tend to fade as the body gets used to the medication.

Wegovy has been approved by our FDA for chronic weight management for adults with a BMI of 30 or more, or 27 or more with a weight-related comorbidity. It is also approved for use in kids down to age 12 if the BMI is at the 95th percentile for age or above. It is quite expensive (~$1,000 per month), but people with insurance coverage often get it for $25 / month, or even free with the manufacturer’s coupon. Before discussing whether or not Wegovy is right for you, it is important to check with your insurance to see if you have coverage, or visit wegovy.com and use their tool.

Wegovy now indicated to reduce the risk of cardiovascular death.

On March 8th, 2024, The FDA approved a new indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. Wegovy should be used in addition to a reduced calorie diet and increased physical activity. Cardiovascular disease is a group of diseases of the heart and blood vessels.

The FDA stated that “Wegovy’s efficacy and safety for this new indication were studied in a multi-national, multi-center, placebo-controlled double-blind trial that randomly assigned over 17,600 participants to receive either Wegovy or placebo. Participants in both groups also received standard-of-care medical treatment (e.g., management of blood pressure and cholesterol) and healthy lifestyle counseling (including diet and physical activity). Wegovy significantly reduced the risk of major adverse cardiovascular events (cardiovascular death, heart attack and stroke), which occurred in 6.5% of participants who received Wegovy compared to 8% of participants who received placebo.”

Read the FDA full release here.

This challenges age-old beliefs that treating obesity with medication is hazardous, and in fact, shows that treating obesity with medication may have other important effects like reducing heart risk and improving lifespan

Medicare adds coverage for anti-obesity medications indicated to reduce cardiovascular death for people at risk for a recurrent event.

On March 21st, 2024, Medicare is going to start covering anti-obesity medications which have been shown to reduce cardiovascular events for those at high risk for a recurrent event (at this time, only Wegovy will qualify).

While this is a step in the right direction, it still leaves the majority of Medicare recipients at risk for a first event without coverage for any medication.

Right now it is too early to see what this will look like, but in coming months, at least a few of our highest risk patients can finally get access to treatment!

Wegovy Shortages Continue

Even if you have coverage for Wegovy, it remains in short supply. If you are wanting to go on Wegovy and your insurance will cover it, the first step is going to be finding the first 3 strengths, which has been a real challenge!

 

How to use a Wegovy Pen

Saxenda (liraglutide)

Liraglutide is the active ingredient in Saxenda and Victoza. Originally studied for type 2 diabetes, it was initially approved for this indication. In 2014, it was approved for chronic weight management and named Saxenda.

Saxenda contains a higher dose (3.0 mg) of liraglutide than Victoza (.6, 1.2, or 1.8 mg). It is self-administered as an injection once daily and provides weight loss that is similar in percentage to the oral medications. The average weight loss for patients treated with Saxenda is 9-10% weight loss at 1 year, or 25 pounds, although in our clinical experience, it is not unusual for patients to lose far more than this when combined with one of CNC’s intensive programs.

Liraglutide mimics the effects of a hormone the human body makes called GLP-1. This hormone is released by our gut when we eat, and not only lowers blood sugar, but also signals the brain that we have just eaten –> that we are satisfied. Patients treated with Saxenda find their hunger and cravings go away and are often replaced with a desire to eat healthier options. It is not a stimulant, so doesn’t keep you awake at night. Side effects include nausea, diarrhea, constipation, and fatigue (among others), but tend to fade as the body gets used to the medication.

Saxenda has been approved by our FDA for chronic weight management for adults with a BMI of 30 or more, or 27 or more with a weight-related comorbidity. It is also approved for use in kids down to age 12 if the BMI is at the 95th percentile for age or above. It is quite expensive (~$1,000 per month), but people with insurance coverage often get it for $25 / month, or even free with the manufacturer’s coupon. Before discussing whether or not Saxenda is right for you, it is important to check with your insurance to see if you have coverage.

How to use a Saxenda Pen

Ozempic

Ozempic has been approved for the treatment of type 2 diabetes. Most insurance plans cover Ozempic, but only for patients with diabetes. We receive many requests from patients for Ozempic when patients erroneously believe their insurance will cover it – it will not unless there is a diagnosis of type 2 diabetes. The cost for Ozempic is similar to the cost for Wegovy.

How to use an Ozempic Pen

GLP-1 Side Effects

This video reviews some of the most common side effects of GLP-1 medications, and tips on how to manage them.

Side effects of GLP-1 Medications

Rybelsus

Rybelsus is an oral form of semaglutide – it is taken as one pill daily in the morning on an empty stomach with a full glass of water. Again, it is only approved for the treatment of type 2 diabetes. The current dose goes as high as 14 mg daily, but a 50 mg dose is in development for the purpose of chronic weight management, and has shown similar weight loss as Wegovy. Again, the cost is similar to Wegovy.

Compounded Semaglutide and Tirzepatide

We have received countless reports of patients being sold “Compounded semaglutide” under the belief that this is the same safe, effective, fda-approved version of semaglutide as what is found in Ozempic, Wegovy, and Rybelsus. Unfortunately, this does not appear to be the case. The FDA released a warning that the version of compounded semaglutide being used by compounding pharmacies is likely a salt form of semaglutide for which no human data exists. We do not know if it is safe or if it is effective. We are advising our patients to listen to the FDA and not use compounded semaglutide.

Read the FDA warning here.

In addition, on June 21st, 2023, Novo Nordisk, the manufacturer of authentic semaglutide, marketed as Rybelsus, Ozempic, and Wegovy, initiated lawsuits against multiple centers selling compounded semaglutide along with multiple manufacturers of compounded semaglutide. Read more about the lawsuit here.

We reserve the right not to accept patients who are using compounded semaglutide, as we do not want to accept the unknown risks of this treatment.

Further, neither Dr. Lazarus nor Heather or Jamie will prescribe or refill compounded semaglutide or tirzepatide, for all the reasons listed above.

Read the FDA’s warnings regarding compounded semaglutide and tirzepatide here. Read the Obesity Medicine Association’s position statement against the use of compounded semaglutide and tirzepatide here.

Compounded Semaglutide and Tirzepatide

We have received countless reports of patients being sold “Compounded semaglutide” under the belief that this is the same safe, effective, fda-approved version of semaglutide as what is found in Ozempic, Wegovy, and Rybelsus. Unfortunately, this does not appear to be the case. The FDA released a warning that the version of compounded semaglutide being used by compounding pharmacies is likely a salt form of semaglutide for which no human data exists. We do not know if it is safe or if it is effective. We are advising our patients to listen to the FDA and not use compounded semaglutide.

Read the FDA warning here.

In addition, on June 21st, 2023, Novo Nordisk, the manufacturer of authentic semaglutide, marketed as Rybelsus, Ozempic, and Wegovy, initiated lawsuits against multiple centers selling compounded semaglutide along with multiple manufacturers of compounded semaglutide. Read more about the lawsuit here.

Lilly has also published an open letter stating that, similar to Novo Nordisk’s actions with regards to compounded semaglutide, that they will be aggressively pursuing legal action against manufacturers of compounded / counterfeit tirzepatide.

We reserve the right not to accept patients who are using compounded semaglutide, as we do not want to accept the unknown risks of this treatment.

Further, neither Dr. Lazarus nor Heather or Jamie will prescribe or refill compounded semaglutide or tirzepatide, for all the reasons listed above.

Read the FDA’s warnings regarding compounded semaglutide and tirzepatide here. Read the Obesity Medicine Association’s position statement against the use of compounded semaglutide and tirzepatide here.

 

*Weight Loss medications are not appropriate for all individuals and will be prescribed only if deemed an appropriate treatment option by Dr. Lazarus or Heather Thomas, PA-C. The purchase of prescription medications from us is completely optional – programs do not include the cost of medication. We stock many medications, but you are welcome to request a written prescription or have our providers e-prescribe to the pharmacy of your choice.