Introduction
If there’s one market in the medical scene that’s booming right now, it’s the weight loss industry. Semaglutide drugs like Ozempic and Mounjaro have been flying off the shelves with their proven efficacy. Hence, patients can’t seem to get enough of their weight reduction benefits.
Apart from these, you also have Trulicity, Victoza, Rybelsus, and Byetta. It can get dizzying since many of these are not just for type 2 diabetes, but for weight management, too.
With all of these options, you might wonder, ‘Which semaglutide has approval for weight loss?’ In this article, we look at semaglutide’s FDA approvals. In addition, we also look at which brands have green light to help treat people who are obese or overweight.
What is semaglutide?
Before we dive into semaglutide and its FDA approval history, let’s understand what it is and how it works. Knowing this will help us differentiate it from its competitor active ingredients such as tirzepatide, dulaglutide, liraglutide, exenatide, and more.
Whenever we eat and our blood sugar levels rise, a hormone in our gut, glucagon-like peptide-1 (GLP-1), springs into action. It prompts the pancreas to bring these down with the hormone insulin.
Semaglutide, a glucagon-like peptide-1 drug receptor agonist (GLP-1 Ra), works in the same way. It mimics GLP-1 by triggering the pancreas to release just the right amount of pancreas to regulate blood sugar levels. It also slows down digestion or delays gastric emptying, the process where food exits the gut, entering the small intestine.
Because people taking semaglutide feel fuller for longer, they have fewer food cravings and don’t think about food as much. Because they consume fewer calories, they end up losing a significant amount of weight. Semaglutide also sends signals to the brain that you’re already full.
Oral and subcutaneous semaglutide
Currently, semaglutide is available via three brands: Ozempic, Wegovy, and Rybelsus. These brands come in two formats: oral semaglutide and subcutaneous semaglutide.
Manufacturers refer to Rybelsus oral semaglutide as it comes in tablet or pill format and is taken orally. Ozempic and Wegovy, meanwhile, come in injectable dosing pens containing a liquid semaglutide solution. Drugmakers refer to them as subcutaneous semaglutide as you need to inject them under the skin.
Dosage and administration
Proper dosage, administration, and storage of semaglutide are key to ensuring semaglutide is working at its best. Your healthcare provider will typically start you on a low dose, gradually increasing this until you reach a maintenance dose. This is to allow your body to get used to the drug.
You must administer Ozempic and Wegovy once weekly regardless of meals. You need to take Rybelsus, meanwhile, once daily on an empty stomach.
The best time to take semaglutide depends on the dosage schedule its manufacturer prescribes.
It’s important you follow the specific steps every time you administer semaglutide to ensure its optimum efficacy. Your healthcare provider should be able to demonstrate how to properly administer the medicine and address any questions you may have.
For best results, take semaglutide along with a balanced diet and exercise.
Which semaglutide has approval for weight loss?
As mentioned, semaglutide has two therapeutic benefits: reducing elevated blood sugar levels and triggering weight loss. What are Ozempic, Wegovy, and Rybelsus’ uses, and which semaglutide has approval for weight loss?
Ozempic and Rybelsus both have FDA approval to treat type 2 diabetes. Ozempic was the first semaglutide to receive FDA approval, for improving blood sugar control in adults with type 2 diabetes. This is in addition to diet and exercise.
Rybelsus, meanwhile, received FDA approval in 2019. This was for improving blood sugar control in adults with type 2 diabetes, together with diet and exercise. The drug was the first GLP-1 receptor agonist with US FDA-approved that people don’t need to inject.
Wegovy, on the other hand, is the semaglutide brand with approval for weight loss. It was the last to receive FDA approval, in 2021. It has approval for chronic weight management in adults. Additionally, it is also for adults with obesity or overweight adults with at least one weight-related condition. This is in addition to a low-calorie diet and increased physical activity. Some examples of these weight-related conditions are type 2 diabetes, high blood pressure, or high cholesterol.
It was an important time as Wegovy was the first weight management drug since 2014 for obese or overweight adults.
Off-label use
Although Ozempic, Wegovy, and Rybelsus are generally safe, not everyone can just take semaglutide. You first need to meet certain diagnostic criteria. Your doctor may have already explained this to you when you received your prescription.
With Ozempic and Rybelsus, you need to have type 2 diabetes. In some cases, your doctor may prescribe either for those with heart disease. This is because they have additional approval for reducing the risk of cardiovascular problems. Doctors may at times also prescribe these for those with insulin resistance.
With Wegovy, on the other hand, you need to have a body mass index (BMI) of 27 or greater. In addition, you must have one weight-related health condition (ex: high blood pressure) or a BMI of 30 or greater.
Safety and efficacy
What data supports Wegovy’s FDA approval? The following is evidence from clinical trials on how it effectively promoted weight loss versus those on placebo.
Four 68-week trials were conducted to test Wegovy’s safety and efficacy. 2,600 adult participants without diabetes received the drug, wihle over 1,500 received placebo. During the beginning of the trial, patients’ average age were 46 years old, with 74 percent being women. On average, participants weighed 231 pounds (105 kilograms) with an average BMI of 38 kilograms.
Those on Wegovy lost an average of 12.4 percent of their starting body weight versus those on placebo.
In another trial–this time with type 2 diabetic adult participants– the average age was 55 years old. Meanwhile, 51 percent were female. At the start of the trial, the average age was 55 years old, with 51 percent being female. On average, participants weighed 220 pounds, with an average BMI of 36 kilograms.
Those who took Wegovy lost an average of 6.2 percent of their starting body weight versus those in placebo.
Adverse reactions
As with any medication, Wegovy comes with potential risks and side effects, as the FDA approval notes. Knowing this, certain patients may avoid potential complications by avoiding semaglutide use.
The most common side effects included nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion, and dizziness. Others were abdominal distension, belching, hypoglycemia (low blood sugar) in patients with type 2 diabetes, gassiness, gastroenteritis, and GERD. Gastroenteritis is a type of intestinal infection, while GERD (gastroesophageal reflux disease( is a type of digestive disorder.
Should you have or have had a history of the following, please inform your healthcare provider immediately.
Thyroid C-cell tumors: People taking Wegovy face a higher risk of developing thyroid C-cell tumors. As such, patients with a personal or family medical history of medullary thyroid carcinoma should avoid it. The same applies to those with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), a rare condition.
Severe allergic reactions: Similarly, patients should avoid Wegovy if they have history of severe allergic reactions to semaglutide or any other Wegovy components. They should stop Wegovy immediately and seek medical help if they suspect a severe allergic reaction.
Acute pancreatitis, gallbladder issues, and more: Wegovy also potentially increases the risk of an inflamed pancreas (pancreatitis), gallbladder problems, low blood sugar, or acute kidney injury. It also increases the risk of diabetic retinopathy (damage to the eye’s retina) and increased heart rate.
Patients must report to their doctor if they have symptoms of pancreatitis or gallstones.
Hypoglycemia (Low blood sugar): Tell your healthcare provider if you are taking Wegovy with insulin or a substance that triggers insulin secretion. This is because this could increase your risk of hypoglycemia (low blood sugar). Your doctor may advise you to lower the dose of insulin or insulin-inducing medicine.
Second approval for teen use
In 2022, Wegovy received its second FDA approval, this time for treating pediatric patients aged 12 years and above. They need to have an initial BMI at the 95th percentile or greater for age and sex. In addition, they must adopt a reduced-calorie diet and increase physical activity to lose weight and keep it off.
This additional approval—called a label expansion—comes from a clinical trial wherein obese teen participants’ BMI decreased by 16.1 percent.
It was a milestone for Novo Nordisk as it helped address the growing challenge of chronic obesity in the US. Moreover, it is with the first-and-only prescription, once-weekly anti-obesity medicine for teens.
Safety and efficacy
Data from a clinical study supports the safety, efficacy, and tolerability of Wegovy as a treatment for teens with obesity.
In a New England Journal of Medicine study, 201 teens received either Wegovy or placebo once weekly for 68 weeks. This was in addition to lifestyle intervention (reduced calorie diet and increased physical activity). The adolescents’ caregivers also received behavioral lifestyle therapy on healthy food options and ways to be more physically active.
At Week 68, Wegovy reduced participants’ BMI up to 16.1 percent—more effective than placebo. 77 percent of participants on Wegovy also experienced a BMI reduction of over or equal to 5 percent, versus placebo.
Adverse reactions: The side effects in the teens were similar to those in adults, although they had greater incidences of gallbladder issues. These included gallstones, low blood pressure, rashes, and itching than the adults who took Wegovy.
Meanwhile, the most common adverse reactions were nausea, vomiting, diarrhea, headache, and abdominal pain.
Overall, Wegovy has FDA approval for chronic weight management in obese/overweight adults with at least one weight-related condition. This is in addition to a reduced-calorie diet and increased physical activity. It was the first weight management drug since 2014 approved for adults who are obese or overweight.
Wegovy received secondary FDA approval for teens with an initial BMI at 95th percentile or greater for age and sex. This was along with a reduced-calorie diet and increased physical activity.
As with any drug, proper dosage and administration are key to ensuring semaglutide is working properly. Patients should constantly update their healthcare provider on their progress with their treatment plan.
Glossary of terms:
- GLP-1: Glucagon-like peptide-1 is a gut-based hormone involved in the secretion of insulin to lower blood sugar levels typically elevated after meals.
- GLP-1 Ra: Glucagon-like peptide-1 receptor agonist. It mimics the actions of GLP-1.
