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*In adults, Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of ≥30 kg/m2 (obesity), or ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. In adolescents (≥12 years), Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with obesity and body weight above 60 kg. Treatment with Wegovy® should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose.1
† For the trial product estimand, the estimated mean (s.e.) change in body weight from baseline to week 104 was –16.7% (0.9) with semaglutide and –0.6% (0.9) for placebo (ETD –16.0 percentage points, 95% CI –18.6 to –13.5). The ‘trial product’ estimand quantified the average treatment effect for the on-treatment period in all randomly assigned participants, assuming that the drug or placebo was taken as intended.2
** 105.6 kg x 0.167 = 17.6 kg
‡ Data from STEP 5. Co-primary endpoints were percentage change in body weight from baseline to week 104 and achievement of weight loss of at least 5% of baseline weight at week 104 (two year).2
§ Mean baseline body weight across entire trial population was 106.0 kg in STEP 5.2
GLP-1 RA, glucagon-like peptide-1 receptor agonist.
*During the trial, randomised treatment was permanently discontinued by 17.1% and 22.4% of patients randomised to semaglutide 2.4 mg and placebo, respectively. Assuming that all randomised patients stayed on treatment and did not receive additional anti-obesity therapies, the estimated changes from randomisation to week 68 for body weight based on a Mixed Model for Repeated Measures including all observations until first discontinuation were -16.9% and -2.4% for semaglutide 2.4 mg and placebo respectively.1,3
† Mean baseline body weight across entire trial population was 105.3 kg in STEP 1.3
**Calculated as weight loss from baseline in STEP 1.3
‡Calculated from difference between STEP 5 results for body weight reduction from baseline (%) for semaglutide 2.4 vs placebo.2
CRP, C-reactive protein; HDL, high-density lipoprotein; LDL, low-density lipoprotein.
*Diastolic blood pressure is a supportive secondary end point.2
†This parameter was an exploratory end point.2
- The most frequently reported adverse reactions were gastrointestinal disorders, including nausea, diarrhoea, constipation and vomiting.1
- The majority of events were of mild-to-moderate in severity and of short duration.1
- Acute pancreatitis have been observed with the use of GLP-1 receptor agonists.1
- Patients should be informed about characteristic symptoms of acute pancreatitis and caution should be used in patients with a history of pancreatitis.1
- Wegovy® should not be used as a subsitute for insulin.1
- Patients treated with Wegovy® in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia.1
- In STEP 2, clinically significant hypoglycaemia was observed in 6.2% of subjects treated with semaglutide compared with 2.5% of subjects treated with placebo; one episode (0.2% of subjects) was reported as severe in a subject not concomitantly treated with a sulfonylurea.1
- Patients with a history of diabetic retinopathy should be monitored for worsening.1
- Diabetic retinopathy was reported by 4.0% of patients receiving Wegovy® and 2.7% of those receiving placebo.1
The safety and efficacy of Wegovy® have not been investigated in patients:1
- Limited experience in patients aged 75 years or more.
- Treated with other products for weight management.
- With type 1 diabetes.
- With severe renal impairment.
- With severe hepatic impairment.
- With congestive heart failure New York Heart Association (NYHA) class IV.
(Check the SmPC for complete list of patient populations not investigated, or in which there is limited clinical experience)
Wegovy® [summary of product characteristics]. Bagsværd, Denmark: Novo Nordisk A/S; March 2024
Garvey WT, Batterham RL, Bhatta M, et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022 Oct;28(10):2083-2091.
Wilding JPH, Batterham RL, Calanna S, et al. STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002.
Rubino D, Abrahamsson N, Davies M, et al. Effect of continued weekly subcutaneous semaglutide vs placebo on weight loss maintenance in adults with overweight or obesity. The STEP 4 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1414-1425.
Davies M, Færch L, Jeppesen OK, et al. Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021 Mar 13;397(10278):971-984.