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*At 104 weeks, mean weight loss was 16.7% with Wegovy® vs 0.6% with placebo in the STEP 5 trial product estimated (assessed treatment effect if a trial product was taken as intended).1 For weight management in adults with a BMI ≥30 kg/m2 with a weight-related comorbidity, and for adolescents aged 12 years and older with an initial BMI ≥95th percentile for age and sex (obesity) along with diet and exercise.1
**Data from STEP 5.
†Mean baseline body weight was 106.0 kg in STEP 5.
‡Calculates as weight loss from baseline.

17% weight loss

(~17 kg) mean weight loss sustained over 68 weeks vs. 2.4% (3 kg) with diet and exercise alone.3*†‡
>1 out of 3 patients

patients achieved ≥20% (~21 kg) weight loss at 2 years.1
6x

greater weight loss vs diet and exercise alone.2

GLP-1 RA, glucagon-like peptide-1 receptor agonist.
*At 68 weeks, mean weight loss was 14.9% vs. 2.4% with placebo in the STEP 1 trial2
**Data from STEP 1 and 4.
† Mean baseline body weight was 105.4 kg in STEP 1; mean body weight at week 0 was 107.2 kg in STEP 4.
‡Calculated as weight loss from baseline in STEP 1 and week 0 in STEP 4.

Waist circumference

15.8 centimetres lost in waist circumference with Wegovy® vs 3.7 centimetres lost with placebo.1
blood-pressure

6.1 mm Hg reduction in systolic blood pressure with Wegovy® vs 0.1 mm Hg reduction with placebo.1
4.4 mm Hg reduction in diastolic blood pressure with Wegovy® vs 0.7 mm Hg reduction with placebo.1*
Glycaemic parameters

At 104 weeks, 80% of those who entered the study with pre-diabetes achieved normal glycaemic status with Wegovy® vs. 37% with placebo.1**
Lipid profile

Reduction in total cholesterol (-3.3% vs +1.4%), LDL cholesterol (-6.1% vs -2.7%) and triglycerides (-19.0% vs +3.7%) along with an increase in HDL cholesterol (+9.6% vs +8.1%) at week 104 compared with placebo.1
CRP

56.7% reduction in CRP with Wegovy® vs 7.8% with placebo.1

CRP, C-reactive protein; HDL, high-density lipoprotein; LDL, low-density lipoprotein.
*Diastolic blood pressure is a supportive secondary end point.
**This parameter was an exploratory end point.

  • Similar to other GLP-1 RAs, the most frequently reported adverse reactions were gastrointestinal.
  • The most common side effects are nausea, diarrhoea, vomiting, constipation and abdominal pain which occurred primarily during the dose-escalation period and improved as patients’ treatment continued. The majority were of mild-to-moderate in severity.
  • Patients should be advised to take precautions to avoid dehydration relating to gastrointestinal side effects.
  • Patients should be informed about characteristic symptoms of acute pancreatitis and caution should be used in patients with a history of pancreatitis.
  • Very few events of acute pancreatitis were reported in clinical trials and were similar for patients receiving Wegovy® or placebo.
  • Wegovy® should not be used as substitute for insulin.
  • Patients treated with Wegovy® in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia.
  • In STEP 2, clinically significant hypoglycaemia was observed in 6.2% of patients treated with Wegovy® compared with 3% of patients treated with placebo; one episode was severe.
  • Patients with a history of diabetic retinopathy should be monitored for worsening.
  • Diabetic retinopathy was reported by 4.0% of patients receiving Wegovy® and 2.7% of those receiving placebo.

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 SmPC for complete list of patients not investigated)

1.

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.

2.

Wegovy® [summary of product characteristics]. Bagsværd, Denmark: Novo Nordisk A/S; 2023.

3.

Wilding JPH, Batterham RL, Calanna S, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Md. 2021;3841(11):989-1002.

4.

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;325(14):1414-1425.

5.

New Drug Therapy Approvals 2022. U.S. Food & Drug Administration. Accessed 15 March 2023 https://www.fda.gov/media/164429/download.

6.

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

 

The information contained in this site is intended for healthcare professionals only outside of the United States of America. This site is not intended to provide medical advice and/or treatment guidance. Only a physician can determine whether a specific product is correct for a particular patient. This site is not country-specific and therefore may contain information which is not applicable to your country. Novo Nordisk accepts no liability for the accuracy, completeness or use of this information, and disclaims any liability to update the information contained on this site. By accessing this site and materials you accept this legal notice and expressly confirm your status as a healthcare professional. Any images shown are models and not real patients.

 

 

HQ24SEMO00032, March 2024