About Wegovy®
Looking to start their journey to chronic weight management today?
Obesity is a common chronic disease in children. In fact, 22% of adolescents aged 12 to 19 years have obesity.1 High BMI levels during childhood and adolescence may be predictive of having a high BMI as an adult.2
Wegovy® is approved for adolescents 12 years and older with an initial BMI at ≥95th percentile for age and sex (obesity), along with diet and exercise3
With Wegovy®, the first and only once-weekly GLP-1 RA for chronic weight management, adolescent patients have another option.
Wegovy® delivers significant, sustained BMI reduction at week 683
PRIMARY END POINT3
16.1% mean reduction in BMI with Wegovy® vs 0.6% (0.2 kg/m2) mean increase in BMI with placebo at 68 weeks
Mean baseline BMI: Wegovy®=37.7 kg/m2; placebo=35.7 kg/m2.
*BMI reduction has been expressed in kg/m2.
SUPPORTIVE SECONDARY END POINT3,4†
14.7% (~36 lb) mean weight reduction with Wegovy® vs 2.7% (~6 lb) weight increase with placebo at 68 weeks†
Mean baseline body weight: Wegovy®=242.3 lb; placebo=226.2 lb.
†Supportive secondary end points were not included in the statistical testing hierarchy and, as such, not controlled for multiplicity.
PRIMARY END POINT: Mean change in BMI (%) from week 0 to week 683,4
All patients transitioned to a 7-week (weeks 68-75) off-treatment lifestyle-therapy-only period.
Mean baseline BMI: Wegovy®=37.7 kg/m2; placebo=35.7 kg/m2.
‡Missing data were imputed from retrieved subjects of the same randomized treatment arm.
Estimated mean change in BMI (%) at 68 weeks3‡
§p<0.0001 (unadjusted 2-sided) for superiority.
16.7% estimated difference between Wegovy® (-16.1%) and placebo (+0.6%) at 68 weeks
Study design3,4
STEP TEENS: A 68-week trial of 201 adolescent patients aged 12 to <18 years, with a BMI in the 95th percentile or higher (according to sex- and age-specific growth charts). Patients were required to have at least 1 unsuccessful dietary weight-loss attempt and also completed a 12-week lifestyle intervention run-in phase. Patients were randomized in a 2:1 ratio to either Wegovy® or placebo for 68 weeks. Patients in both arms also received behavioral lifestyle therapy, consisting of counseling on healthy nutrition and physical activity for weight loss (a goal of 60 minutes/day of physical activity). The 68-week treatment period was followed by a 7-week follow-up period during which patients did not receive Wegovy® or placebo. During the trial, 10% of patients in each of the Wegovy® and placebo arms discontinued treatment.
Primary end point3:
- Change in BMI (%) from baseline to week 68
Select supportive secondary end points3,4:
- Change in body weight (%) from baseline to week 68
- Proportion of patients achieving ≥5% BMI reduction from baseline to week 68
Additional parameters from Prescribing Information3:
- Proportion of patients achieving ≥10% and ≥15% BMI reductions from baseline to week 68
BMI, body mass index; GLP-1 RA, glucagon-like peptide-1 receptor agonist.
More patients achieved BMI reductions at multiple thresholds with Wegovy® at week 683
Mean baseline BMI: Wegovy®=37.7 kg/m2; placebo=35.7 kg/m2.
*Supportive secondary end points were not included in the statistical testing hierarchy and, as such, not controlled for multiplicity.
†Parameters not included in the pre-specified hierarchical testing.
Study design3,4
STEP TEENS: A 68-week trial of 201 adolescent patients aged 12 to <18 years, with a BMI in the 95th percentile or higher (according to sex- and age-specific growth charts). Patients were required to have at least 1 unsuccessful dietary weight-loss attempt and also completed a 12-week lifestyle intervention run-in phase. Patients were randomized in a 2:1 ratio to either Wegovy® or placebo for 68 weeks. Patients in both arms also received behavioral lifestyle therapy, consisting of counseling on healthy nutrition and physical activity for weight loss (a goal of 60 minutes/day of physical activity). The 68-week treatment period was followed by a 7-week follow-up period during which patients did not receive Wegovy® or placebo. During the trial, 10% of patients in each of the Wegovy® and placebo arms discontinued treatment.
BMI, body mass index; GLP-1 RA, glucagon-like peptide-1 receptor agonist.
Adverse reactions reported in ≥3% of Wegovy®-treated adolescent patients aged 12 and older and more frequently than with placebo3
In a clinical trial
- Gastrointestinal disorders were the most frequent adverse events with Wegovy® (62% vs 42% with placebo)3
- 2.3% of patients treated with Wegovy® vs 1.5% of patients who received placebo discontinued treatment as a result of gastrointestinal adverse events3
- Mean increases in resting heart rate of 1.2 beats per minute from baseline were observed with patients taking Wegovy® vs a decrease of 2.3 beats per minute with placebo3
- Adverse reactions with Wegovy® treatment in pediatric patients aged 12 years and older were similar to those reported in adults. Pediatric patients aged 12 years and older treated with Wegovy® had greater incidences of cholelithiasis, cholecystitis, hypotension, rash, and urticaria compared to adults treated with Wegovy®3
There are insufficient data in pediatric patients with type 2 diabetes treated with Wegovy® for obesity to determine if there is an increased risk of hypoglycemia with Wegovy® treatment similar to that reported in adults. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In pediatric patients aged 12 years and older with type 2 diabetes, monitor blood glucose prior to starting Wegovy® and during Wegovy® treatment. When initiating Wegovy® in pediatric patients aged 12 years and older with type 2 diabetes, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.3
Once-weekly dosing regimen designed with the adolescent patient in mind
Gradual Wegovy® dose escalation gives patients time to adjust to treatment3*
Dose-escalation schedule
Start your patients with once-weekly Wegovy® at 0.25 mg and escalate the dose every 4 weeks.
Injected subcutaneously once weekly.
*Follow the dose-escalation schedule to minimize gastrointestinal adverse reactions.
What to do if adolescent patients...
Need additional time to adjust to Wegovy®3:
If patients do not tolerate a dose during dose escalation:
Consider delaying dose escalation for 4 weeks.
If adolescent patients do not tolerate the maintenance 2.4 mg dose:
The dose can be decreased to 1.7 mg once weekly.
Discontinue Wegovy® if the patient cannot tolerate the 1.7 mg dose.
Miss dose(s) of Wegovy®3:
Patients miss 1 dose and the next dose is:
>2 days (48 hours): Instruct them to administer Wegovy® as soon as possible.
<2 days (48 hours): Inform them to NOT administer a dose of Wegovy®. Resume dosing on the regularly scheduled day of the week.
Patients miss more than 2 consecutive doses:
Inform them to resume dosing as scheduled. Or if needed, inform them to reinitiate Wegovy® and follow the dose-escalation schedule, which may reduce the occurrence of GI symptoms associated with reinitiation of treatment.
BMI, body mass index; GI, gastrointestinal; GLP-1 RA, glucagon-like peptide-1 receptor agonist.
Goal:
Wants to achieve a lower BMI before starting college
History:
Elevated blood glucose levels; mother has obesity and high blood pressure
Previous weight-loss attempts:
Family has tried to implement a structured weight-management plan with healthy eating and physical activity goals, but he still feels hungry all the time
BMI, body mass index; GLP-1 RA, glucagon-like peptide-1 receptor agonist.
Your eligible patients could save on Wegovy®
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)
- pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater standardized for age and sex (obesity)
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
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 Wegovy®
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: Treatment with Wegovy® was associated with an increased occurrence of cholelithiasis and cholecystitis. The incidence of cholelithiasis and cholecystitis was higher in Wegovy® pediatric patients aged 12 years and older than in Wegovy® adults. In clinical trials in adult patients, 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. In a clinical trial in pediatric patients aged 12 years and older, cholelithiasis was reported by 3.8% of Wegovy® patients and 0% placebo patients. Cholecystitis was reported by 0.8% of Wegovy® pediatric patients and 0% placebo patients. Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in Wegovy® patients than in placebo patients, even after accounting for the degree of weight loss. 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 adult 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 Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with Wegovy®. 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 adult 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® adult patients compared to placebo in clinical trials. More Wegovy® adult 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%). In a clinical trial in pediatric patients aged 12 years and older with normal baseline heart rate, more patients treated with Wegovy® compared to placebo had maximum changes in heart rate of 20 bpm or more (54% versus 39%). 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
- Most common adverse reactions (incidence ≥5%) are: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distention, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis
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
- Pediatric: Adverse reactions with Wegovy® in pediatric patients aged 12 years and older were similar to those reported in adults. Pediatric patients ≥12 years of age treated with Wegovy® had greater incidences of cholelithiasis, cholecystitis, hypotension, rash, and urticaria compared to adults treated with Wegovy®
Please click here for Prescribing Information, including Boxed Warning.
1. Wegovy™ [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2021.
References
1. Center for Disease Control and Prevention (CDC). Childhood obesity facts. Accessed February 24, 2023. https://www.cdc.gov/obesity/data/childhood.html
2. Hampl S, Hassink S, Skinner A, et al. Clinical practice guideline for the evaluation and treatment of children and adolescents with obesity. Pediatrics. 2023;151(2):e2022060640.
3. Wegovy® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2022.
4. Weghuber D, Barrett T, Barrientos-Pérez M, et al. Once-weekly semaglutide in adolescents with obesity. N Engl J Med. 2022;387(24):2245-2257.