GLP-1, glucagon-like peptide-1 receptor agonist.
Treatment with Wegovy™ resulted in statistically significant reduction in body weight of 14.9% vs 2.4% with placebo at 68 weeks
Co-primary end point: mean change in body weight (%) from baseline to week 68*†
BMI, body mass index.
Missing data were imputed from retrieved subjects of the same randomized treatment arm (RD-MI).
*STEP 1 was a 68-week trial that enrolled 1,961 patients with obesity (BMI ≥30 kg/m2) or with overweight (BMI 27 kg/m2-29.9 kg/m2) and at least 1 weight-related comorbid condition, such as treated or untreated dyslipidemia or hypertension; patients with type 2 diabetes mellitus were excluded. Patients were randomized in a 2:1 ratio to either WegovyTM or placebo.
†All patients received instruction for a reduced-calorie diet (approximately 500 kcal/day deficit) and increased physical activity counseling (recommended to a minimum of 150 min/week) throughout the trial.
‡p<0.0001 (unadjusted 2-sided) for superiority.
§Difference from placebo was -12.4%.
Greater proportions of patients treated with Wegovy™ achieved 5%, 10%, and 15% weight loss than those treated with placebo
Co-primary end point: mean change in body weight (%) from baseline to week 68*†
BMI, body mass index.
*STEP 1 was a 68-week trial that enrolled 1,961 patients with obesity (BMI ≥30 kg/m2) or with overweight (BMI 27 kg/m2 - 29.9 kg/m2) and at least 1 weight-related comorbid condition, such as treated or untreated dyslipidemia or hypertension; patients with type 2 diabetes mellitus were excluded. Patients were randomized in a 2:1 ratio to either Wegovy™ or placebo.
†Observed data from in-trial period including imputed data for missing observations (RD-MI).
Safety with Wegovy™
Adverse reactions reported in ≥2% of patients treated with Wegovy™ and more frequently than with placebo
In clinical trials:
- 6.8% of patients treated with Wegovy™ and 3.2% of patients treated with placebo permanently discontinued treatment as a result of adverse reactions
- 73% of patients treated with Wegovy™ and 47% of patients treated with placebo reported gastrointestinal disorders
- Most frequently reported reactions were nausea (44% vs 16%), vomiting (24% vs 6%), and diarrhea (30% vs 16%)
— These reactions increased during dose escalation
- Permanent discontinuation of treatment as a result of a gastrointestinal adverse reaction occurred in 4.3% of patients treated with Wegovy™ vs 0.7% of patients treated with placebo
T2DM, type 2 diabetes mellitus.
*Includes abdominal pain, abdominal pain upper, abdominal pain lower, gastrointestinal pain, abdominal tenderness, abdominal discomfort, and epigastric discomfort.
†Includes fatigue and asthenia.
‡Defined as blood glucose <54 mg/dL with or without symptoms of hypoglycemia or severe hypoglycemia (requiring the assistance of another person) in patients with type 2 diabetes not on concomitant insulin.
§Includes chronic gastritis, gastritis, gastritis erosive, and reflux gastritis.
Changes in anthropometry and cardiometabolic parameters at week 68
HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; LDL, low-density lipoprotein; LSMean, least squares mean.
Missing data were imputed from retrieved subjects of the same randomized treatment arm (RD-MI).
*Model-based estimates based on analysis of covariance model including treatment as a factor and baseline value as a covariate.
†Not included in the pre-specified hierarchical testing.
‡Model-based estimates based on a mixed model for repeated measures including treatment as a factor and baseline values as a covariate.
§Baseline value is the geometric mean.
WegovyTM is not indicated to treat hypertension, diabetes mellitus, dyslipidemia, or cardiovascular disease.
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Important Safety Information for Wegovy™ (semaglutide) injection 2.4 mg
WARNING: RISK OF THYROID C-CELL TUMORS
- In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Wegovy™ causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
- Wegovy™ is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Wegovy™ and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Wegovy™.
Indications and Usage
Wegovy™ (semaglutide) injection 2.4 mg is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of ≥30 kg/m2 (obesity) or ≥27 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
Limitations of Use
- Wegovy™ contains semaglutide and should not be coadministered with other semaglutide-containing products or with any GLP-1 receptor agonist.
- The safety and effectiveness of Wegovy™ in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
- Wegovy™ has not been studied in patients with a history of pancreatitis.
Important Safety Information cont.
Contraindications
- Wegovy™ is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in Wegovy™. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with semaglutide.
Warnings and Precautions
- Risk of Thyroid C-Cell Tumors: Patients should be further evaluated if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging.
- Acute Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including semaglutide. Acute pancreatitis was observed in patients treated with Wegovy™ in clinical trials. Observe patients carefully for signs and symptoms of acute pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be accompanied by vomiting). If acute pancreatitis is suspected, discontinue Wegovy™ promptly, and if acute pancreatitis is confirmed, do not restart.
- Acute Gallbladder Disease: In clinical trials, cholelithiasis was reported by 1.6% of Wegovy™ patients and 0.7% of placebo patients. Cholecystitis was reported by 0.6% of Wegovy™ patients and 0.2% of placebo patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
- Hypoglycemia: Wegovy™ lowers blood glucose and can cause hypoglycemia. In a trial of patients with type 2 diabetes, hypoglycemia was reported in 6.2% of Wegovy™ patients versus 2.5% of placebo patients. Patients with type 2 diabetes taking Wegovy™ with an insulin secretagogue (e.g. sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms. Monitor blood glucose in patients with type 2 diabetes.
- Acute Kidney Injury: There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which in some cases required hemodialysis, in patients treated with semaglutide. Patients with renal impairment may be at a greater risk of acute kidney injury, but some events have been reported in patients without known underlying renal disease. A majority of the events occurred in patients who experienced nausea, vomiting, or diarrhea, leading to volume depletion. Monitor renal function when initiating or escalating doses of Wegovy™ in patients reporting severe adverse gastrointestinal reactions and in patients with renal impairment reporting any adverse reactions that could lead to volume depletion.
- Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with semaglutide. If hypersensitivity reactions occur, discontinue use of Wegovy™, treat promptly per standard of care, and monitor until signs and symptoms resolve. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist.
- Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: In a trial of patients with type 2 diabetes, diabetic retinopathy was reported by 4.0% of Wegovy™ patients and 2.7% of placebo patients. Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
- Heart Rate Increase: Mean increases in resting heart rate of 1 to 4 beats per minute (bpm) were observed in Wegovy™ patients compared to placebo in clinical trials. More Wegovy™ patients compared with placebo had maximum changes from baseline of 10 to 19 bpm (41% versus 34%) and 20 bpm or more (26% versus 16%). Monitor heart rate at regular intervals and instruct patients to report palpitations or feelings of a racing heartbeat while at rest. If patients experience a sustained increase in resting heart rate, discontinue Wegovy™.
- Suicidal Behavior and Ideation: Suicidal behavior and ideation have been reported in clinical trials with other weight management products. Monitor patients for depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Wegovy™ in patients who experience suicidal thoughts or behaviors and avoid in patients with a history of suicidal attempts or active suicidal ideation.
Adverse Reactions
- The most common adverse reactions reported in ≥5% of patients treated with Wegovy™ are 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.
Drug Interactions
- The addition of Wegovy™ in patients treated with insulin has not been evaluated. When initiating Wegovy™, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.
- Wegovy™ causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. Monitor the effects of oral medications concomitantly administered with Wegovy™.
Use in Specific Populations
Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue Wegovy™. Discontinue Wegovy™ in patients at least 2 months before a planned pregnancy.
Please click here for Wegovy™ Prescribing Information, including Boxed Warning.
1. Wegovy™ [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2021