Diabetes Drug Ozempic Approved for Weight Loss
Wegovy, a once-weekly injectable medication (semaglutide), has been approved by the FDA to treat obesity and excess weight – conditions that can lead to type 2 diabetes and prediabetes. This new treatment has led to significant weight loss in clinical trials.
Editor's Note: This article has been updated to reflect the recent draft guidance for Wegovy from the National Institute for Health Care and Excellence in the UK.
Obesity is a complicated and serious chronic condition that can lead to many other complications – including type 2 diabetes, prediabetes, and heart disease. As of 2018, almost half (42%) of adults in the US lived with obesity, defined as a body mass index (BMI) over 30 kg/m2. However, most people with obesity are undiagnosed, and less than 3% have been prescribed a medicine to help them manage their condition. Although obesity and excess weight can directly lead to type 2 diabetes and prediabetes, weight management can reduce that risk – preventing or delaying the onset of these diseases.
On June 4, 2021 the FDA approved Novo Nordisk’s Wegovy (generic name: semaglutide), a once-weekly injection for chronic weight management. Semaglutide, a GLP-1 receptor agonist drug, is also approved in the US to treat type 2 diabetes as a once-weekly injection (Ozempic) and as a tablet taken orally (Rybelsus). In addition to improving diabetes management, Ozempic and Rybelsus support heart health. Ozempic is specifically approved to reduce the risk of serious heart problems, including heart attacks, strokes, and heart-related deaths in adults with type 2 diabetes and heart disease. A clinical trial is currently investigating whether Ozempic can slow the progression of chronic kidney disease in people with type 2 diabetes.
In April 2022, the FDA approved Ozempic for a 2.0 mg dose, which was based on clinical trial data from SUSTAIN FORTE showing the higher dose led to a better A1C and to weight loss. Having an additional dosing option for Ozempic will give healthcare providers and people with diabetes an additional alternative to personalize treatment based on their health goals. In addition, not all health insurance plans cover obesity treatment, so people with diabetes and excess weight or obesity may not have been able to access Wegovy with the higher dose of semaglutide. Because Ozempic is already an established diabetes medication covered by most insurance plans and Medicare, access to a higher dose may not be a problem. Talk to your healthcare professional if you have type 2 diabetes and are interested in the blood sugar, or heart-protective effects of this medication.
Wegovy is a slightly higher dose than Ozempic at 2.4 mg, and in the STEP 1 clinical trial, it averaged 14.9% weight loss. Wegovy is now approved for people with obesity (BMI greater than 30 kg/m2) or excess weight (BMI greater than 27 kg/m2) who also have at least one other weight-related health condition, such as type 2 diabetes, high blood pressure, or high cholesterol. The drug is used in combination with a reduced calorie meal plan and increased physical activity to support weight loss.
Wegovy’s STEP 1 clinical trial, published in the New England Journal of Medicine, included 1,961 people with obesity or excess weight who did not have diabetes. The weight loss results were impressive:
People taking Wegovy (in addition to diet and physical activity changes) lost, on average, 14.9% of their body weight after about 16 months, compared to only 2.4% weight loss in participants using the meal plan and exercise regimen without Wegovy.
83.5% of people taking Wegovy were able to lose at least 5% of their body weight, achieved by only 31.1% of people not taking Wegovy.
Dr. Donna Ryan, a renowned obesity researcher from the Pennington Biomedical Research Center at LSU, said, “[This] is the best news I have [heard] in a long time, and I have been eagerly awaiting it.” And Dr. Robert Kushner from Northwestern University, who was an author on the research papers that led to Wegovy’s approval, said, “The approval of Wegovy provides the availability of a more effective medication for the management of obesity and sets the stage for a new generation of drugs that harness the benefits of naturally occurring hormones such as GLP-1.”
Wegovy is now available to people in the US and Novo Nordisk estimated in their 2022 Capital Markets Day report that roughly 125,000 people are on Wegovy. The cost of the drug may vary depending on whether you have health insurance that covers the medication; not all health insurance covers obesity treatment. Some people without insurance may qualify for a $25 monthly copay assistance program.
In addition to the FDA approval last year, as of February, people in the UK may soon be able to get Wegovy on the National Health Service (NHS, the UK’s public healthcare system). This also comes from results of the STEP 1 trial. The National Institute for Health and Care Excellence (Nice) in the UK issued draft recommended guidance that would allow people to access the drug so long as they:
- Have at least one weight-related complication, and
- A BMI of at least 35, or
- A lower BMI threshold for exceptional cases or for people of south Asian, Chinese, and Black African or Caribbean family backgrounds.
Treating obesity and excess weight as chronic conditions could help prevent people from developing type 2 diabetes and other health complications. The new type of treatment may also help address the stigma around diabetes and obesity – neither condition is a lifestyle choice nor personal flaw, but rather the two are medical conditions involving a number of factors, including genetics and environment.