A lot has changed ever since semaglutide hit the market. People from all walks of life, even celebrities and business tycoons, have achieved slimmer figures because of the revolutionary drug. It not only lowers blood sugar levels but also promotes weight loss.
You may already know about the semaglutide brand Ozempic, which has been high on people’s radar for weight management. But there are other semaglutide brands, and it might get confusing to differentiate one from the other. Apart from Ozempic, you have Wegovy and Rybelsus, too.
With all these variants, which is the semaglutide for weight loss? How was it approved for use?
In this article, we take a look back at semaglutide’s FDA approval for weight loss. Specifically, we’ll look into what exactly the drug is approved for and its proven effectiveness in clinical trials.
Semaglutide: An overview
Before we discuss the history of semaglutide’s approval for weight loss, let’s understand what it is and how it works.
What is semaglutide?
Whenever we finish eating and our blood sugar levels are elevated, there’s a hormone in our gut that activates. It’s called glucagon-like peptide-1 (GLP-1) and it prompts the pancreas to release another hormone, insulin, to reduce blood glucose.
Now, semaglutide is a glucagon-like peptide-1 receptor agonist, or GLP-1 Ra for short. It mimics the actions of GLP-1 in lowering blood sugar levels.
Another effect of semaglutide is that it slows down digestion, causing you to feel fuller for a longer period. As a result, you have fewer cravings and don’t feel like eating as much, leading to weight loss.
Additionally, semaglutide decreases food intake by activating GLP-1 receptors located in parts of the brain involved in appetite regulation.
With all these therapeutic benefits, it’s no wonder that the US FDA gave its stamp of approval to semaglutide. In the next section, let’s look at the approval details and the clinical studies that prove its safety and efficacy.
Semaglutide’s FDA approval for weight loss
Although Danish pharmaceutical company Novo Nordisk developed semaglutide in 2012, it wasn’t until 2021 that it received approval. Specifically, it was on June 4, 2021 when the US FDA approved semaglutide under the brand name Wegovy.
First approval of semaglutide for adult use
The US FDA approved Wegovy for chronic weight management in adults with obesity or overweight adults with at least one weight-related condition. Moreover, people taking Wegovy must also be on a lower calorie diet and increase their physical activity. Some examples of applicable weight-related conditions are type 2 diabetes, high blood pressure, or high cholesterol.
It’s important to note that Wegovy comes in pre-filled injectable dosing pens. Hence, you must administer it subcutaneously, meaning, inject it under the skin. The drug’s approval marked an important time in medicine. This was because it was the first weight management drug since 2014 to receive approval for treating obese or overweight adults.
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 tested Wegovy’s safety and efficacy, involving over 2,600 adult participants without diabetes and 1,500 receiving placebo. During the beginning of the trial, patients’ average age was 46 years old, with 74 percent being women. On average, participants weighed 231 pounds (105 kilograms) with an average BMI of 38 kilograms.
Those who received Wegovy lost an average of 12.4 percent of their starting body weight versus those on placebo.
Another trial involved adult participants with type 2 diabetes. Of these participants, 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 on 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 noted by the FDA approval. Knowing this, certain patients may avoid potential complications by avoiding semaglutide use.
The most common side effects reported included nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion, dizziness, and abdominal distension. Other common side effects include belching, hypoglycemia (low blood sugar) in patients with type 2 diabetes, and gassiness. Additonally, it also included gastroenteritis (a type of intestinal infection) and gastroesophageal reflux disease (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 an increased risk of developing thyroid C-cell tumors. As such, it should be avoided by patients with a personal or family medical history of medullary thyroid carcinoma. People with a rare condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) must also refrain from taking Wegovy.
- Severe allergic reactions: Patients should avoid Wegovy if they have a history of severe allergic reactions to semaglutide or any of Wegovy’s components. Moreover, 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, and low blood sugar. In addition, it also heightens the risk of acute kidney injury, diabetic retinopathy, increased heart rate, and suicidal behavior. Patients must report to their doctor if they have symptoms of pancreatitis or gallstones.
Hypoglycemia (Low blood sugar)
You should tell your healthcare provider if you taking Wegovy with insulin or a substance that triggers insulin secretion. This is because this could increase your risk of hypoglycemia (low blood sugar). You may be advised to lower the dose of insulin or insulin-inducing medicine.
Second approval of semaglutide for teen use
In 2022, Wegovy received its second FDA approval, this time to cater to pediatric patients aged 12 years and above. To take the drug, they musts have an initial BMI at the 95th percentile or greater for age and sex. This is in addition to a reduced-calorie diet and increased physical activity to manage weight.
This additional approval is based on a clinical trial wherein the obese teen participants’ BMI decreased by 16.1 percent. It was a significant milestone for Novo Nordisk as it helped address the growing challenge of chronic obesity in the US. More so because Wegovy was the first-and-only prescription, once-weekly anti-obesity medicine for teens.
Safety and efficacy
Data from a clinical study also supports the safety, efficacy, and tolerability of Wegovy as treatment for teens with obesity. In a New England Journal of Medicine study, 201 teens took 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 the participants’ BMI by up to 16.1 percent—more effective than placebo. Additionally, the BMI of 77 percent of those on Wegovy went down by 5 percent or greater versus placebo.
Adverse reactions
The side effects in the teens were similar to those in adults, although they had greater incidences of gallbladder issues. This included more instances of gallstones, low blood pressure, rashes, and itching than the adults who took Wegovy. The most common adverse reactions, meanwhile, were nausea, vomiting, diarrhea, headache, and abdominal pain.
Using Wegovy
Now that we know about Wegovy’s FDA approval, we can learn how to use it for weight loss purposes.
Eligibility
If you wish to take Wegovy, you have to meet certain criteria. You must have a BMI of 27 or greater with one weight-related condition, or a BMI of 30 or greater.
Dosage
To help your body adjust to Wegovy, your healthcare provider will typically start you off on a low dose. This is usually at 0.25 mg until you reach a maintenance dose.
As mentioned, Wegovy is a subcutaneous form of semaglutide and it should be injected once weekly. It comes in five various dose strengths: 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg.
Should you miss a dose of Wegovy and the next is over two days away, take the missed dose immediately. If the next dose is less than two days away, skip the missed dose. Then take the next dose of Wegovy according to schedule.
If you miss a dose for more than two weeks, use it on the next scheduled day of the dose. You may also want to consult your doctor about restarting the treatment.
Administration
Wegovy can be injected subcutaneously in three different areas: your 1) abdomen, 2) thigh, or 3) upper arm. It should be administered once weekly, on the same day each week, at any time with or without meals.
It should not be used along with other products containing semaglutide, other GLP-1 receptor agonists, or other weight loss drugs. These include prescription drugs, over-the-counter drugs, or herbal products.
Obtaining Wegovy
If you are eligible to use Wegovy, you must ask for a prescription from your healthcare provider. Once you have a prescription, you can buy semaglutide online or at any pharmacy.
If you have health insurance, it should cover the cost of semaglutide.
Conclusion
Wegovy marks an important time in medicine as it is the first FDA-approved adult weight loss drug since 2014.
Apart from lowering blood sugar levels, Wegovy also promotes weight loss. Clinical trials provide evidence of how safe, effective, and tolerable it is in adults with obesity. Pediatric patients, meanwhile, must have at least one weight-related condition, in addition to a healthy diet and increased physical activity.
The FDA approval also noted Wegovy’s adverse effects and warnings of potential risks. These include thyroid C-cell tumors, severe allergic reactions, acute pancreatitis, gallbladder issues, and hypoglycemia.
Fully disclose to your healthcare provider aspects of your medical history as well as any current medications you are taking. This is because Wegovy may affect the efficacy of these. Follow your treatment plan’s prescribed dosage and report any adverse reactions immediately.
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 agonists mimic GLP-1 in the production of insulin to control blood sugar levels.
