This transcript has been edited for clarity.
Hi. Today we're going to talk about another form of semaglutide. This form is called Wegovy, and it's indicated for weight loss in people with or without diabetes. It's a higher dose than we've used before — 2.4 mg weekly. It has been FDA-approved and is coming on the market soon.
The indications, based on the package insert, are a BMI ≥ 30 kg/m2 or a BMI ≥ 27 kg/m2 with one weight-related comorbid condition such as diabetes. Like the other GLP-1 receptor agonists, it has a black box warning for medullary thyroid carcinoma, and it should not be used in patients with a personal or family history of multiple endocrine neoplasia (MEN) syndrome.
I read through the package insert in its entirety, and there wasn't much that caught my eye. But the one thing we need to be aware of is that there was an increase in rates of acute gallbladder disease. This was probably because of the weight loss that we saw, but it's something to know.
In clinical trials, cholelithiasis was reported by 1.6% of those taking semaglutide and 0.7% of those taking placebo. And in terms of cholecystitis, the rates were 0.6% with the higher dose of semaglutide vs 0.2% with placebo. These are relatively low rates, but they can certainly occur. There is also a concern about pancreatitis, so know that these can occur and you need to watch out for them if a patient has signs or symptoms of either.
The STEP Trials Broken Down
The data that were used for approval came from four phase 3 trials — the STEP program, which involved 4500 adults. We have lots of data on semaglutide from the trials for the treatment of diabetes, so we know this drug fairly well in terms of risks and benefits.
STEP 1 looked at obesity or overweight with a comorbidity, and the primary endpoint was percent change in weight from baseline to 68 weeks. With placebo, there was a 2.4% reduction in weight vs a 14.9% reduction in weight with the semaglutide.
STEP 3 is my favorite form of study because it involved intensive lifestyle intervention in conjunction with a medication. In this study, they gave lifestyle intervention to individuals with obesity or overweight and a preexisting comorbidity. Patients receiving only lifestyle intervention lost 5.7% of their body weight, compared with 16% of their body weight with semaglutide.
And finally, we have STEP 4, which was pretty interesting. The investigators basically took everybody and randomized them to semaglutide or a placebo and watched them for 20 weeks. Then, in a subset of them, semaglutide was stopped and they were given placebo to see what happens to their weight. Those on semaglutide continued to lose weight vs those on placebo, whose weight loss stopped, and the weight actually started to go back up again.
Wegovy is going to be dispensed in single-dose pens. This is different from the pens we have for Ozempic. Each box of pens will include four single-dose pens, and they'll be one of five different dose strengths: 0.25, 0.5, 1, 1.7, and 2.4 mg. Every four weeks, the patient is supposed to go up to a higher dose strength until they get to the maximum tolerated dose or 2.4 mg.
These pens have a preattached needle, so the patient just has to twist off the top and give the dose. I don't think the patient has to interact with the needle much at all. These are very simple pens and very simple instructions, but we need to make sure that we give patients enough of these dose packs so that they can actually go up on the dose every month until they get to the 2.4-mg dose.
I'm really looking forward to using Wegovy in my patients who need weight loss. I think it's going to be effective. It's a drug that we've known for a number of years, so it's going to be different in terms of our experience of prescribing something "new." But we all have to wait for this to become approved on various formularies, and a big issue that we've all had is getting approval for weight loss drugs for our patients. Hopefully, this will somehow be easier; I'm always an optimist. And never forget to discuss lifestyle with your patients, because they'll do even better if they take this and improve their lifestyles.
Anne L. Peters, MD, is a professor of medicine at the University of Southern California (USC) Keck School of Medicine and director of the USC clinical diabetes programs. She has published more than 200 articles, reviews, and abstracts, and three books, on diabetes, and has been an investigator for more than 40 research studies. She has spoken internationally at over 400 programs and serves on many committees of several professional organizations.
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Cite this: All About Wegovy for Weight Loss - Medscape - Jun 21, 2021.