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What to Know About a “Breakthrough” Weight Loss Drugs

The drugs, Wegovy® and Ozempic® have been in the news and trending on social media due to their unprecedented success in helping people lose large amounts of weight. Ozempic (semaglutide) was approved by the FDA for the treatment of type 2 diabetes back in 2017. While studying Ozempic for diabetes, researchers noticed that patients taking the drug also lost weight. This led to clinical trials specifically designed to test semaglutide for weight loss in overweight and obese patients, and the subsequent approval by the FDA of the drug, albeit at higher doses than those used for type 2 diabetes, under the name  Wegovy (semaglutide)1. Wegovy and the type 2 diabetes medication, Ozempic, contain the same active ingredient, called semaglutide, but Wegovy is generally given at a higher dose.  Our experts at PHM answer some common questions about the recently FDA approved drug, Wegovy.

What is Wegovy?

Wegovy is an injectable medication, to be used along with a reduced calorie diet, for chronic weight management. It is manufactured by Novo Nordisk and FDA-approved for use in adults who are overweight or obese and in children who are over 12 years old and obese.

Why are the Wegovy weight loss results considered impressive?

In a study of adults treated with a weekly injection of Wegovy, along with some lifestyle changes, patients had an average body weight reduction of 15% over the course of 16 months.2 In comparison, patients who did not receive the drug lost just 2.4% of their body weight. Wegovy has also been shown to be effective in teenagers, who lost an average of 16% of their body weight.3 To date, there have been no other FDA-approved weight loss drugs that have demonstrated such a dramatic reduction in body weight.4 The results achieved in the Wegovy studies approach the level of weight loss seen in patients who have bariatric surgery, without the need for an invasive procedure.2

How does Wegovy work?

Wegovy works by mimicking a hormone that is released in your gut after eating. This hormone, called glucagon-like peptide (GLP-1), is involved telling your brain that you feel full and slowing the rate at which you digest food. Wegovy enhances how GLP-1 works, which decreases signals of hunger from your brain and makes you feel full faster1.

How is wegovy administered?

Wegovy is designed to be self-injected once a week into the abdomen, arm, or leg. To minimize side effects, patients usually start at the lowest dose (0.2mg/0.5ml) and gradually increase to the highest dose (2.4mg/0.75ml) over the course of a few months.

Who is supposed to take Wegovy?

Wegovy is approved for chronic weight control adults who are obese, as defined by having a body mass index (BMI) of greater than 30, or overweight (BMI of > 27) along with either type 2 diabetes, cholesterol imbalance, or high blood pressure. It is also approved for use in children aged 12 and older with BMI in the 95th percentile for their height, age, and sex.5 

What are the common side effects of Wegovy? Are there any severe side effects/risks?

The most common side effects of Wegovy are gastrointestinal in nature, including nausea, diarrhea, vomiting, and constipation, along with fatigue and headache5. Less common side effects include inflammation of the pancreas, gall bladder disease, low blood sugar, kidney damage, and heart rate increase.

Studies of Wegovy in mice have a risk for developing medullary thyroid cancer. Although it is not known whether Wegovy can cause this cancer to develop in humans, patients with a family history of medullary thyroid cancer or multiple endocrine neoplasia should not take Wegovy.5

Those who are pregnant or planning to become pregnant should not take Wegovy, as studies in animals suggest that Wegovy may cause harm to developing babies.5

Why is there controversy about Wegovy and Ozempic in the news?

While Wegovy is approved by the FDA only for patients who are overweight or obese, some people who do not meet these criteria are taking Wegovy anyway, in what is known as an “off-label” way.

This trend has caused a nationwide shortage of Wegovy7, so as a substitute, some doctors have begun prescribing Ozempic for weight management. Ozempic is the same drug but used at a different dosage and is approved for blood sugar control in adults with type 2 diabetes6. It is important to note that Wegovy has not been studied in patients who are not overweight or obese and that Ozempic is not approved for weight loss.

How much does Wegovy cost and is it covered by insurance?

The list price of Wegovy is close to $1,400 for a 28-day supply. It is covered by some insurance companies, especially if you are in the group approved by the FDA. For those taking the medication “off-label,” it may be more difficult to get insurance coverage. There have also been reports of some insurance companies not covering Wegovy because they consider  it a “vanity drug” rather than an obesity treatment.

How long Would I need to take wegovy?

Currently, it is not known whether patients will need to continue long-term treatment with Wegovy to maintain weight loss. In one study, patients who stopped taking Wegovy regained about 2/3 of the weight that they had lost.8 This may suggest that patients will have to keep taking the medication to maintain their weight loss.

Are there any other weight loss drugs that have shown similar effectiveness?

There is another type 2 diabetes medication, called Mounjaro® (terzepitide) that has also demonstrated dramatic weight loss in patients being treated for diabetes (21% reduction in body weight, on average).9 It works in a similar way to Wegovy, but it mimics a different hormone. Terzepitide is not currently approved for weight loss, but it will be under review by the FDA for this use in early 2023.

References

  1. Commissioner, O. of the. FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014. FDA https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014 (2021).
  2. Wilding, J. P. H. et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine 384, 989–1002 (2021).
  3. Weghuber, D. et al. Once-Weekly Semaglutide in Adolescents with Obesity. N Engl J Med 387, 2245–2257 (2022).
  4. Idrees, Z., Cancarevic, I. & Huang, L. FDA-Approved Pharmacotherapy for Weight Loss Over the Last Decade. Cureus 14, (2022).
  5. Prescribing Wegovy® | Wegovy® (semaglutide) Injection 2.4 mg. novoMEDLINK https://www.novomedlink.com/obesity/products/treatments/wegovy/dosing-administration/prescribing-wegovy.html, https://www.novomedlink.com/obesity/products/treatments/wegovy/dosing-administration/prescribing-wegovy.html.
  6. Prescribing Information | Ozempic® (semaglutide) injection 0.5 mg or 1 mg. https://www.ozempic.com/prescribing-information.html.
  7. FDA Drug Shortages. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm.
  8. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension – PubMed. https://pubmed.ncbi.nlm.nih.gov/35441470/.
  9. Jastreboff, A. M. et al. Tirzepatide Once Weekly for the Treatment of Obesity. New England Journal of Medicine 387, 205–216 (2022).
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