Is Semaglutide FDA Approved for Weight Loss?

Semaglutide is classified as a glucagon-like peptide-1 (GLP-1) receptor agonist and binds to receptors located in the gastrointestinal tract, pancreas, and brain. It’s a medication that was initially developed for the treatment of type 2 diabetes but has since shown significant potential in aiding weight loss.

Semaglutide is approved by the FDA as three separate brand name medications (forms of semaglutide): Ozempic®, Rybelsus^®, and Wegovy^®.  Each version contains semaglutide as its active component and comes with its associated indications, preparations, and dosages.

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What is the difference between Ozempic, Rybelsus, and Wegovy? 

Due to the increased complexity involved, it’s important to understand every FDA-approved semaglutide indication and its current use.

Ozempic®: Semaglutide for Type 2 Diabetes

In 2017, the FDA approved semaglutide under the brand name Ozempic® for the management of type 2 diabetes (T2D). Ozempic® is administered as a once-weekly injection and functions as a GLP-1 receptor agonist, which helps regulate blood sugar levels by enhancing insulin secretion, slowing gastric emptying, and reducing appetite. This multifaceted approach makes semaglutide an effective tool for those managing type 2 diabetes.

Semaglutide has gained recognition not only for its role in managing T2D but also for its weight loss benefits.  In clinical trials, semaglutide (Ozempic®) demonstrated significant results in improving glycemic control and aiding weight loss. Participants who received semaglutide saw substantial reductions in their HbA1c levels, a key marker of blood sugar control, and experienced notable weight loss compared to those who received a placebo. Specifically, in a trial enrolling adults with type 2 diabetes, individuals who received Semaglutide (Ozempic) lost 6.2% of their initial body weight compared to those who received a placebo. [5]

The success of semaglutide (Ozempic®) has made it a popular choice among healthcare providers for patients struggling with T2D and weight management. It offers a dual benefit, addressing two major health concerns simultaneously. However, as with any medication, patients need to discuss with their healthcare provider to ensure semaglutide is suitable for their specific health needs, considering any potential risks and side effects.

Rybelsus^®: Semaglutide Tablets

In 2019, the FDA approved semaglutide oral tablets (Rybelsus®) as an adjunct to diet and exercise to enhance glycemic control in adults with T2DM. It contains the same active ingredient as the injections Ozempic and Wegovy, and it’s the first oral medication of its kind (GLP-1 agonist) to treat T2D. 

Although not FDA-approved for weight loss, clinical trial data has shown that higher doses of Rybelsus® are also effective for weight loss. The OASIS 1 trial tracked weight loss in adults taking oral semaglutide (Rybelsus^®) 50 mg compared to those taking a placebo for 68 weeks. People in the semaglutide group lost about 17% of their starting body weight, on average. The FDA’s Center for Drug Evaluation and Research is evaluating the approval of oral semaglutide for weight loss, providing yet another alternative to patients with obesity.

Wegovy^®: Semaglutide for Weight Loss

In June 2021, the FDA approved a once-weekly semaglutide injection of 2.4 mg, marketed as Wegovy^®, specifically for chronic weight management. Weekly semaglutide 2.4 mg (Wegovy^®, Novo Nordisk), a GLP-1 receptor agonist, is the first approved drug for chronic weight management in adults with general obesity or overweight since 2014. [3]. 

This drug is indicated for chronic weight management in adults who are obese or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol) for use in addition to a reduced calorie diet and increased physical activity.

Semaglutide (Wegovy^®) works by reducing appetite and enhancing feelings of fullness, which helps individuals consume fewer calories. The effectiveness and safety of semaglutide (Wegovy^®) for weight loss were demonstrated in a large, multi-national, multi-center, placebo-controlled trial. 

This extensive study involved over 17,600 participants who were randomly assigned to receive either semaglutide (Wegovy^®) or a placebo. Participants who used semaglutide (Wegovy^®) experienced an average weight loss of 12.4% of their initial body weight compared to those who received a placebo. [4]

Semaglutide has emerged as a game-changer for weight loss, offering hope to many individuals struggling with obesity.  By incorporating semaglutide into their weight management plan, individuals have a promising new option to help them achieve their weight loss goals.

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FDA Expands Semaglutide Approval

In an exciting development in March of 2024, the FDA has expanded the approval of semaglutide for cardiovascular weight reduction,  an added benefit for those struggling with both obesity and cardiovascular disease. [5]  This decision came after significant findings from the SELECT clinical trial, which revealed that Semaglutide as Wegovy™ not only aids in weight loss but also reduces the risk of major adverse cardiovascular events.

SELECT showed that major adverse cardiovascular events, such as cardiovascular death, heart attack, and stroke, occurred in 6.5% of participants who received Wegovy compared to 8% of participants who received a placebo. [7]

It means that semaglutide can now be considered a treatment option that not only helps manage weight but also addresses cardiovascular disease. This approval marks a significant step forward in the battle against obesity and its related health complications, providing a broader spectrum of benefits for patients and healthcare providers.

What About Compounded Semaglutide?

Semaglutide products can be prescribed in two forms: the brand-name version, which the FDA approves, and a compounded version, which can be obtained from a compounding pharmacy. 

Given the rise in demand for effective weight loss solutions, some patients may consider a compounded drug as an alternative to brand-name products. When a drug is in shortage, compounding pharmacies can legally create "a copy" of approved medications, as is the case with semaglutide and other GLP-1 receptor agonists.[6]

Compounding involves creating a customized medication by combining, mixing, or altering ingredients to meet the specific needs of a patient. While this practice can offer personalized treatment options, it’s important to note that compounded medications are not FDA-approved; their safety, efficacy, and quality are not evaluated in the same manner as FDA-approved drugs. However, they are compounded in the United States by licensed compounding pharmacies that follow state and FDA guidelines.

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How Does Semaglutide Work?

Semaglutide, a GLP-1 receptor agonist, works by mimicking the hormone incretin. Incretin is the naturally produced GLP-1 receptor agonist. This hormone helps to lower blood sugar levels and slows gastric emptying, contributing to an overall reduction in appetite. Furthermore, semaglutide activates receptors in the brain that reduce sensations of hunger, alleviate food cravings, and enhance the feelings of satiety. [1] [2]

These unique qualities make semaglutide a valuable tool for healthcare prescribers and patients looking to manage obesity and weight loss.

Its effectiveness in weight loss was demonstrated in a large placebo-controlled trial, where participants who received Semaglutide (Wegovy^®) experienced an average reduction of 12.4% of their initial body mass index (BMI) compared to those on a placebo (a dummy pill). 

Studies have shown that the weight loss needed to prevent and treat the complications of obesity that impair health and quality of life is at least 10% to 15% of BMI. This impressive result highlights the potential of semaglutide as a powerful tool for weight management and risk reduction. [4]

Potential Semaglutide Side Effects and Considerations

When considering semaglutide, it's important to be aware of potential side effects and have an open dialogue with your healthcare provider. Common side effects include gastrointestinal issues such as nausea, vomiting, diarrhea, and constipation. It’s important to monitor your blood sugar, as another common side effect is hypoglycemia (low blood sugar). These symptoms are usually mild to moderate and tend to decrease over time as your body adjusts to the medication.

Some individuals may experience more serious side effects, such as pancreatitis, gallbladder problems, or allergic reactions. It's crucial to inform your healthcare provider immediately if you notice severe abdominal pain, jaundice, or signs of an allergic reaction like rash, itching, or difficulty breathing.

Additionally, patients with a history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) should avoid using semaglutide due to the potential risk of thyroid c-cell tumors. 

Your healthcare provider will help assess your medical history and determine if semaglutide is the right option, considering any pre-existing conditions or medications you may be taking.

Monitoring your progress and any side effects is essential. Regular follow-ups with your healthcare provider will ensure that any adverse effects are managed effectively and that the treatment remains beneficial for your weight management journey.

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Bottom Line

Semaglutide has made a significant difference for both patients and healthcare providers. The extensive clinical trials have showcased semaglutide effectiveness and safety for T2D, weight loss, and cardiovascular benefits. The results have provided confidence to healthcare professionals in recommending semaglutide as a viable option for patients struggling with chronic weight management.

Patients have reported remarkable weight loss, improved quality of life, and enhanced overall health. This has been particularly encouraging for those who have faced challenges in losing weight through traditional methods alone. Healthcare providers now have a powerful tool to address weight management and related health concerns, such as cardiovascular risks.

By working closely with your healthcare team, you can maximize semaglutide's benefits while minimizing potential risks. This balanced approach will support your efforts in achieving a healthier, more fulfilling life.

Connect with the experts at LookMeds today and start your weight loss journey with a personalized solution and ongoing support.

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