Wegovy’s safety and efficacy were studied in four 68-week trials. Three were randomized, double-blind, placebo-controlled trials (including 16 weeks of dose increases), and one was a randomized, doubleblind, placebo-controlled withdrawal trial in which patients receiving Wegovy either continued with the treatment or switched to a placebo. More than 2,600 patients received Wegovy for up to 68 weeks in the four studies, and more than 1,500 patients received placebo.
The largest placebo-controlled trial enrolled adults without diabetes. The average age at the beginning of the trial was 46 years, and 74% of patients were female. The average body weight was 231 pounds (105 kg), and average BMI was 38 kg/m2. Patients who received Wegovy lost an average of 12.4% of their initial body weight compared with those who received placebo.
Another trial enrolled adults with type 2 diabetes and an average age of 55 years, and 51% were female. The average body weight was 220 pounds (100 kg) and average BMI was 36 kg/m2. In this trial, patients who received Wegovy lost 6.2% of their initial body weight compared with those who received placebo.
The most common adverse effects of Wegovy include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distention, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease.
The prescribing information for Wegovy contains a boxed warning to inform healthcare professionals and patients about the risk of thyroid C-cell tumors. Wegovy should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called multiple endocrine neoplasia syndrome type 2. Moreover, Wegovy should not be used in patients with a history of severe allergic reactions to semaglutide or any of the other components of Wegovy. Patients should stop Wegovy immediately and seek medical help if a severe allergic reaction is suspected.
Wegovy also contains warnings for pancreatitis, gallbladder problems (including gallstones), low blood sugar, acute kidney injury, diabetic retinopathy, tachycardia, and suicidal behavior or ideation. Patients should discuss with their healthcare professional whether they have symptoms of pancreatitis or gallstones. If Wegovy is used with insulin or a substance that causes insulin secretion, patients should speak to their healthcare provider about potentially lowering the dose of insulin or the insulin-inducing drug to reduce the risk of low blood sugar.
Healthcare providers should monitor patients with kidney disease, diabetic retinopathy, and depression or suicidal behaviors or thoughts. More information about this drug can be found at www.novopi.com/wegovy.pdf.
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