Introduction
Ozempic, the brand name for semaglutide, is a drug developed for the treatment of diabetes. It helps increase the body’s production of insulin, helping control and regulate blood sugar. It was subsequently found that Ozempic reduces appetite and increases satiety, the feeling of being full. As a result, patients were losing weight while on the medication.
This phenomenon led to the sudden burgeoning of Ozempic use by non-diabetics who wanted the weight loss benefits of the drug, with mixed results and newly discovered side effects.
FDA Approval And Usage For Ozempic
FDA Status
Currently, Ozempic, as well as its sister drug Wegovy, are only FDA approved for the management of diabetes and weight loss in obesity. Both are semaglutides, and are injectables. Studies have shown that Ozempic in diabetics can control blood sugars, reduce the Hemoglobin A1C (a blood test that measures average blood sugars over time and is a good indicator of blood sugar control), and produce weight loss. Other studies have shown that it has similar results to more standard treatments like metformin and Avandia.
Off-Label Use
Many drugs have multiple uses and not all those uses have been approved by the FDA. Botox is an example, where it is FDA approved for migraines or forehead lines, but is also used in other areas of the face for cosmetic purposes.
Using a drug “off-label” means that the FDA has not proven the efficacy and safety of the drug for that treatment purpose or indication. The FDA allows off-label use of a medication if the treating physician feels that it would be beneficial for the patient and alternative approved medications have failed. As a result, physicians have discretion to prescribe medications to their patients outside the approved indications by the FDA.
Mechanism Of Action
Hormone Mimicry
Ozempic is a GLP-1 agonist, meaning that it acts on receptor sites the same way the natural hormone does. GLP-1, short for Glucagon-like peptide, is a hormone released when blood glucose increases after eating. Type 2 diabetics cannot make sufficient insulin to metabolize the glucose they consume. Ozempic, like the GLP-1 hormone, binds to receptor sites (think lock and key mechanism) in the pancreas where insulin is made, activating the release of insulin to manage the glucose load. This is how Ozempic can help diabetics regulate their blood glucose levels.
Impact On The Brain And Gut
These hormones also slow down digestion, which may be the cause of one of the side-effects of Ozempic, nausea. They act primarily on receptors in the brain that affect stomach and intestine motility and stimulate the satiety center of the brain. As a result, appetite is suppressed and less calories are consumed.
Discontinuation Effects Of Ozempic Use
For diabetics, Ozempic is long-term treatment that can help with the management of their diabetes. It helps them with weight management as well. Recently, there has been a rise in the use of Ozempic by non-diabetics for the sole purpose of weight loss. Because being overweight is a multi-factorial problem, the root causes must be addressed either instead of using Ozempic or while being treated.
Proper diet and reasonable exercise are the most important elements in weight loss that lasts. Using Ozempic can produce weight loss, although it will be minimal without a proper diet. Once Ozempic is discontinued, most patients will regain the weight within 6-12 months if no change in eating behavior has occurred.
Side Effects of Ozempic
Like any medication, Ozempic and the GLP-1 agonists have side effects. Some of these are:
- Nausea
- Diarrhea
- Bloating
- Pancreatitis
- Low blood sugar (hypoglycemia)
- Increased risk of thyroid tumors
- Anaphylaxis
Weight Loss Results
Clinical Studies With Ozempic
Studies have shown that on average, people can lose 5 – 20% of their body weight in 6 to 12 months. Obese people without diabetes tended to lose more weight. More weight loss occurs with lifestyle change, including diet and exercise.
Understanding Weight Loss Plateaus
Many people trying to lose weight are frustrated by the inevitable weight loss plateau. This is a common reason for patients abandoning their attempts to lose weight.
Weight loss plateau is a real phenomenon that typically occurs 4 to 6 months into dieting. There are many causes. The brain can act like a thermostat and set your weight at a certain level. Attempts to change that through diet and exercise or medication can trigger the brain to believe that starvation is occurring, and so it reacts by increasing hunger and storing more fat. So either calories must be reduced or calorie burning increased.
For most people, increasing the calorie burn will be easier and healthy if the diet is good. During this time, the thermostat will reset, and the plateau will disappear.
The Differences Between Ozempic and Wagovy
Dosage and Composition
Ozempic and Wegovy have the same chemical composition. The difference between them is the recommended dosage. Ozempic is typically a lower dose and is used primarily to treat type 2 diabetes. Wegovy is a higher dose of semaglutide that is used for weight loss in obese patients with or without diabetes.
FDA Clearances
Both Ozempic (in 2017) and Wegovy (in 2021) are FDA approved as treatments for diabetes and weight loss in obese patients. They are both made by Novo Nordisk. The company has been seeing record revenues as a result of exceptional sales and favorable results.
Expert Opinions
Medical Perspectives
The semaglutide medications have been in general use for over 5 years, and most internists and endocrinologists feel that they have a place in the treatment of diabetes and obesity. Most physicians, like Dr. Lisa Arian, an internist and endocrinologist in San Diego, feel that, when used appropriately, they provide an effective and safe treatment for these patients. However, like most physicians who treat these conditions, indiscriminate use for weight loss in non-obese patients presents several problems.
“We don’t fully understand the long-term effects of these medications. And while obesity is a medical problem that often can’t be treated with diet and exercise alone, being overweight can. Using a medication like Wegovy or Ozempic is a temporary fix at best, and the weight will return as soon as the drug is stopped without adequate lifestyle changes.”
Lisa Arian, MD
Nevertheless, for significantly overweight patients who are at risk for diabetes or heart problems, these medications can be a springboard to successful long term weight loss.
Supply And Demand Challenges
There has been a huge surge in use of Ozempic and Wegovy in the last 2 years due to its success in helping people lose weight. As a result, there are now supply problems that are impacting availability for patients that depend on these medication for proper treatment of serious medical problems. Many healthcare providers are also struggling with prescribing these medications for patients that are not diabetics or obese when shortages are imminent.
Obesity Statistics
Obesity is defined as a Body Mass Index (BMI) greater than 30. In general, a BMI over 40 is considered “Morbid Obesity” and carries high risks for cardiovascular disease, cancer, and diabetes. BMI is determined using height and weight measurements. Here is a link to a BMI calculator.
According to the CDC, over 40% of the US population is considered obese, and almost 10% severely or morbidly obese. Globally, 13 % of the population is considered obese, while 39% are overweight.
Obesity and its concomitant diseases like hypertension, diabetes, heart disease, stroke, and cancer cost the healthcare system billions of dollars every year. Medical costs for obese patients is on average $2000 a year more than those of normal weight.
Prescription Criteria
Currently, the FDA has approved Ozempic for treatment of diabetes only. Wegovy has been approved for weight loss in patients with a BMI over 30, a BMI of 27 if there are accompanying diseases like hugh blood pressure or diabetes that are related to being overweight.
Does Insurance Cover Ozempic or Wegovy?
Medicare covers both drugs if strict criteria are met. Other insurnce companoes vary in both coverage and specific criteria.
It is advisable to meet with your primary care physician or endocrinologist to determine if you meet the criteria for insurance coverage. If not, and the physician feels the drugs would be appropriate, the medications can still be prescribed but would have to be paid for by the patient.
What Is The Cost Of Ozempic Or Wegovy Without Insurance?
The out of pocket cash cost for these medications ranges from $1000 to $1400 per month. Beware of advertised lower cost versions as these may be compounded and less effective.
Future Advances
Other And Upcoming Medications
Mounjaro (Tirzepatide)
Mounjaro works on GLP-1 and GIP receptors to help control diabetes, It is a once-a-week injection that helps with weight loss but is approved only for diabetes treatment. It has similar side effects to Ozempic.
Rybelsus
Rybelsus is an oral version of semaglutide that has been shown to help with weight loss and diabetes control. It is taken daily 30 to 60 minutes prior to eating.
Retatrutide
Retatrutide is the newest medication undergoing trials and in 2 major studies has been not only effective in treating type 2 diabetes, but resulted in significantly more weight loss than Ozempic and other semaglutides. In one study published in the New England Journal of Medicine, patients lost on average 24% of their body weight. Another larger study will be completed in 2025, and if similar results are reported, Retatrutide could become the most precribed semaglutide. It not only has a similar mechanism of action, but also mimics glucagon receptors, which decreases appetite and increases metabolism.
The current studies have shown a minimal weight loss plateau effect, so that longer effective use of the drug may be indicated. Side effects are similar to Ozempic.
Conclusion
The desire for weight loss is a global one. Diet fads or trendy pills and supplements have been around for decades, especially in first-world nations where food is abundant. So are Ozempic and the other semaglutide medications the answer?
These medications should be used only after careful evaluation by a physician. There are side effects and drug interactions that need to be considered. In addition, the long term effects of these drugs in people with out diabetes or serious obesity are still not fully understood.
For most people, proper diet and exercise remain the safest and most effective treatment for being overweight.
