The obesity epidemic continues to plague America, with approximately two-thirds of the population overweight or obese. Individuals who are overweight or have obesity are more likely to develop Type 2 diabetes (T2D). Aside from weight loss, semaglutide may prevent heart attacks and ischemic strokes in adults with T2D and a history of heart disease. Semaglutide is the active ingredient in three popular medications, Wegovy®, Ozempic®, and Rybelsus®. This article delves into the use of Rybelsus, an oral form of semaglutide, for weight loss, particularly in individuals without diabetes.
Understanding Semaglutide and Rybelsus
Semaglutide belongs to the category of drugs known as glucagon-like peptide-1 receptor agonists (GLP-1 RAs). GLP-1 receptor agonists mimic the action of GLP-1, a hormone naturally produced in the intestines in response to food intake. When you eat, your intestines release GLP-1, signaling the pancreas to release insulin. Insulin helps the body absorb glucose (sugar) from the blood into cells for energy or storage. GLP-1 ensures insulin is released when needed, especially after meals when blood glucose levels tend to rise.
Additionally, GLP-1 reduces the secretion of another pancreatic hormone called glucagon, which has the opposite effect of insulin by increasing blood sugar levels. By inhibiting glucagon, GLP-1 helps prevent excessive release of glucose from the liver, which can lead to high blood sugar levels.
GLP-1 agonists like Rybelsus may also slow down the emptying of the stomach (gastric emptying). This helps regulate the rate at which nutrients from your meal enter the bloodstream, preventing sudden spikes in blood sugar levels after eating. Slower stomach emptying can also make you feel full for longer, potentially reducing your overall calorie intake.
Rybelsus is the oral version of semaglutide and is the first GLP-1 pill. Rybelsus improves blood sugar levels in adults with T2D. The medication is taken once daily in conjunction with diet and exercise.
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Rybelsus and Weight Loss: How Does It Work?
Rybelsus is FDA-approved for the treatment of type 2 diabetes. It is not formally approved as a chronic weight management aid. However, it has been shown to lead to weight loss in patients when coupled with a healthy diet and regular exercise. Because 90% of adults with type 2 diabetes also have obesity or are overweight, the benefits of Rybelsus affect both conditions.
Rybelsus may result in weight loss through two actions: blood sugar management and appetite reduction.
Blood Sugar Management
Semaglutide, the active ingredient in Rybelsus, encourages the pancreas to release insulin, which helps move glucose (sugar) from the blood into cells for energy. This action stabilizes blood sugar levels and reduces the chance of sudden energy swings that can make you crave high-calorie foods. Also, semaglutide effectively stops the production of glucagon, another hormone that raises blood sugar levels, by telling the liver to release stored glucose into the blood. By controlling glucagon, Rybelsus keeps blood sugar levels steady and prevents excessive hunger caused by low blood sugar.
Appetite Reduction
Rybelsus's impact extends beyond blood sugar control; it also regulates appetite. GLP-1 receptors in the brain, especially in the hypothalamus, control our hunger and fullness. When GLP-1 binds to these receptors, it tells the brain to reduce appetite and cravings. This means you'll feel less hungry and more satisfied with smaller meals. Rybelsus also slows down how quickly the stomach empties its contents into the small intestine. Slower stomach emptying means food stays in your stomach longer after you eat, making you feel full for a longer time and reducing the urge to eat more. Rybelsus is prescribed alongside lifestyle changes like eating fewer calories and exercising more. It's not meant to be the only treatment for obesity.
Clinical Evidence: Rybelsus for Weight Loss in Non-Diabetics
The weight loss benefit of semaglutide in patients with diabetes is well-documented, but its clinical utility in treating obesity among patients without diabetes is less described. A clinical study (OASIS 1) with 709 participants found that adults without type 2 diabetes who took oral semaglutide daily experienced greater weight loss compared to those on a placebo. Reported side effects were similar to those seen in studies looking at people with type 2 diabetes, and mainly consisted of stomach-related side effects.
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Novo Nordisk has released key findings from the OASIS 1 phase 3a trial, part of the global OASIS program. The 68-week trial involved 667 adults who were overweight or obese with weight-related health issues. It compared a once-daily 50 mg dose of Rybelsus, alongside lifestyle changes, to a placebo for weight management. The trial successfully met its primary goal, showing that oral semaglutide 50 mg led to significant and superior weight loss compared to the placebo.
Specifically, participants taking the oral medication achieved a substantial 17.4% weight loss after 68 weeks, while those on the placebo experienced only a 1.8% reduction. Furthermore, 89.2% of the oral semaglutide group achieved a weight loss of 5% or more, compared to only 24.5% in the placebo group. When considering treatment adherence, those on oral semaglutide 50 mg dose still achieved a significant 15.1% weight loss compared to a 2.4% reduction in the placebo group. Additionally, 84.9% of the oral semaglutide group reached a 5% or more weight loss, compared to 25.8% with placebo.
A meta-analysis was performed in accordance to the PRISMA 2020 statement. A comprehensive systematic search of PubMed/MEDLINE, Cochrane and Google scholar was performed from inception to June 2021 to identify publications in the English or foreign language with adequate English translations on semaglutide versus placebo and other GLP-1 RAs for weight loss in obesity without T2DM. The search strategy was “semaglutide” AND “obesity.” No filter was used. Ongoing trials were also sought in the relevant search. Two reviewers (HCT and MMM) independently searched the databases to identify all potentially eligible studies and reviewed the full articles for inclusion. Selected articles were then compared and the decision to include the article was reached through a consensus.
The study included 4 randomized controlled trials having a total of 3,613 individuals with obesity without diabetes. The mean difference for weight reduction was -11.85%, favoring semaglutide [95% confidence interval (CI) (-12.81,-10.90), p<0.00001].
These findings suggest that Rybelsus can be an effective tool for weight loss in non-diabetic individuals when combined with lifestyle modifications.
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Dosage and Administration
Rybelsus is not approved by the FDA for weight loss, meaning there is no formal recommended dosage for this use. For type 2 diabetes, Rybelsus is available in 3 mg, 7 mg, and 14 mg tablets. The recommended dosage of Rybelsus will vary depending on the individual and their specific needs. Your healthcare provider will start you at a lower dosage for 30 days. After 30 days, this dosage may increase depending on your condition and how well you tolerate the medication.
Usually, Rybelsus is taken orally once daily. You should take the tablet 30 minutes before you eat, drink, or take any other medications.
Important Considerations When Taking Rybelsus
Rybelsus isn’t known to interact with any particular foods, but consuming it with food may affect the amount of the drug absorbed by your body. It’s best to take Rybelsus in the morning at least 30 minutes before eating or consuming drinks (other than up to 4 ounces of water). Rybelsus is most effective when combined with regular exercise and a balanced diet. Consuming a diet high in whole, unprocessed foods with minimally added sugar can potentially help you keep your blood sugar levels under control if you have type 2 diabetes.
To maximize weight loss, it’s best to combine Rybelsus or other weight-loss drugs with regular exercise and a balanced diet. This includes eating foods that are:
- High in fiber, such as fresh, whole fruits, many fresh vegetables, beans and legumes, brown rice, and oats.
- High in protein, such as seafood, eggs, yogurt, nuts, and seeds.
It also includes avoiding certain types of foods, such as those that are:
- High in trans or saturated fats, such as fried foods, processed meats, and full-fat dairy products.
- Highly processed and high in added sugars, such as candies, sodas, packaged baked goods, and certain fruit juices.
- High in salt.
A balanced diet also includes limiting or eliminating alcohol, which can add a significant number of calories to your diet with no nutritional benefits.
Potential Side Effects and Precautions
Rybelsus was found to be safe and well-tolerated. However, it may cause side effects in some people. The most common side effects of Rybelsus are gastrointestinal issues that include nausea, vomiting, diarrhea, constipation, heartburn, and abdominal pain.
More serious side effects may occur, but they are uncommon. Some serious adverse effects of Rybelsus use include:
- Increased heart rate
- Low blood sugar (hypoglycemia)
- Allergic Reactions: Rash, swelling, breathing difficulties
- Pancreatitis (inflammation of the pancreas)
- Gallbladder problems, including gallstones
- Increased risk of thyroid cancer
If you experience any side effects while taking Rybelsus, seek medical attention from a licensed healthcare provider.
Before starting treatment with any prescription medication, you should tell your doctor about any medical conditions you have, any prescription drugs or supplements you are taking, and any allergies you may have. This information will help reduce the risk of any drug interactions or severe side effects. A history of pancreatitis, gallbladder problems, kidney problems, personal or family history of medullary thyroid carcinoma (MTC) (thyroid tumors), multiple endocrine neoplasia syndrome type 2 (MEN2), diabetic retinopathy (eye problems), and any digestive disorders should be discussed with your doctor. Rybelsus may not be prescribed to pregnant women, women who are trying to conceive, or women who are breastfeeding.
Rybelsus vs. Other Semaglutide Medications: Ozempic and Wegovy
Rybelsus, Ozempic, and Wegovy are all medications made by the pharmaceutical company Novo Nordisk, and they serve different purposes in managing health. Rybelsus is used to help control blood sugar levels in people with type 2 diabetes. It comes in a convenient pill form that you take by mouth. Rybelsus helps your body process sugar more effectively and supports weight loss.
Ozempic is also used to manage blood sugar levels in type 2 diabetes but is given as an injection under the skin. It's typically taken once a week and can help lower blood sugar, promote weight loss, and reduce the risk of cardiovascular problems in people with diabetes.
Wegovy is a medication designed for weight management in people who are overweight or obese, whether they have diabetes or not. It's given as a weekly injection and can help you lose weight by making you feel less hungry and more satisfied with smaller meals.
In summary, Rybelsus is for controlling blood sugar and weight in people with type 2 diabetes, Ozempic is primarily for managing blood sugar and promoting weight loss in those with diabetes, and Wegovy is specifically for weight management in people who are overweight or obese. These medications have different forms of administration (pill or injection) and target various aspects of health. Your healthcare provider can help determine which is right for you based on your health needs and goals.
Alternatives to Rybelsus for Weight Loss
Rybelsus is not FDA-approved for weight loss. The decision to prescribe Rybelsus is at the discretion of your healthcare provider. If you are curious about alternatives to Rybelsus, discuss these options with your provider:
- Tirzepatide (available as Mounjaro or Zepbound): Tirzepatide is a medication used for both type 2 diabetes and obesity management. It aids in regulating blood sugar levels, reducing appetite, and slowing stomach emptying. The brand name Zepbound, containing tirzepatide, is specifically approved for obesity treatment in patients without type 2 diabetes.
- Liraglutide (available as Saxenda): Liraglutide, a GLP-1 receptor agonist, holds FDA approval for treating obesity in adults and adolescents aged 12 and above. It accomplishes this by lowering blood sugar levels, suppressing appetite, and delaying stomach emptying.
- Metformin: Metformin, a prescription diabetes medication, can lead to weight loss in some individuals. This is achieved by regulating blood sugar levels and enhancing insulin sensitivity, which reduces the amount of sugar circulating in the bloodstream.
- Topiramate (available as Topamax): Topiramate, an anticonvulsant drug, has demonstrated weight loss effects in certain patients. Its exact mechanism of action is not entirely understood, but it is believed to reduce calorie intake through appetite suppression, prevent excess fat storage, lower specific fat and cholesterol levels, and potentially impact the brain's reward system to reduce binge eating. It's important to note that while Topiramate is not FDA-approved as a weight loss medication, clinical trials have shown significant weight loss in individuals taking it compared to those on a placebo.
- Contrave (bupropion/naltrexone): Contrave is a combination drug composed of two active ingredients, bupropion and naltrexone, each with distinct mechanisms contributing to its weight loss effects. Primarily, Contrave acts on the brain to control appetite and reduce cravings for high-calorie foods. It's essential to be aware that Contrave may have serious side effects, including the potential for suicidal thoughts.
Accessing Rybelsus: Prescription and Cost
Rybelsus is a prescription drug, meaning that you must have a written order from a licensed healthcare provider to get it. It cannot be purchased over the counter. Rybelsus is available under its brand name. There are no generic versions of Rybelsus currently available.
Weight loss drugs are prescribed to individuals with obesity or individuals who are overweight and managing a weight-related health condition. If you are curious about Rybelsus or any other weight loss drug, talk to your healthcare provider about whether or not these treatment options are right for you. You should also discuss the cost, potential side effects, and any concerns you may have.
The cost of all GLP-1 agonists, including Rybelsus, is quite high. Rybelsus is $892 for 30 tablets, with 7.0 mg of strength. While this may seem expensive, it’s essential to consider the potential benefits and effectiveness of the medication. The manufacturer of Rybelsus provides a savings offer for people with commercial or private insurance. Other resources are also available to help you determine your cost and coverage for Rybelsus on the manufacturer’s site.