Wegovy
Authorised
This medicine is authorised for use in the European Union
semaglutide
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Wegovy is used together with diet and physical activity to help people lose weight and keep their weight under control. It is used in adults who have:
- a BMI of 30 kg/m² or greater (obesity) or
- a BMI of at least 27 kg/m² but less than 30 kg/m² (overweight) who have weight-related health problems (such as diabetes, high blood pressure, abnormal levels of fats in the blood, breathing problems during sleep called obstructive sleep apnoea or a history of heart attack, stroke or blood vessel problems).
It is also used in adolescents from 12 years of age whose BMI is at or above the 95th percentile for their age and gender (obesity) and who weigh more than 60 kg.
BMI (body mass index) is a measure of your weight in relation to your height. A BMI at the 95th percentile means that it is greater than that of 95% of people of the same age and gender.
Wegovy contains the active substance semaglutide.
Wegovy can only be obtained with a prescription.
The medicine is available as pre-filled pens for injection and as tablets to be taken by mouth. The pens are for adults and adolescents from 12 years of age, while the tablets are only intended for adults.
The injection is given once a week under the skin in the belly, thigh or upper arm. Patients can inject the medicine themselves by following the instructions included in the package leaflet.
The tablets are taken once a day on an empty stomach, after at least 8 hours of fasting. Patients should wait 30 minutes before eating, drinking or taking other medicines.
To reduce the risk of side effects affecting the gut, the dose is gradually increased over 16 weeks.
For more information about using Wegovy, see the package leaflet or contact your doctor or pharmacist.
The active substance in Wegovy, semaglutide, is a GLP-1 receptor agonist. It acts in the same way as GLP-1 (a natural hormone in the body) and helps regulate appetite by increasing a person’s feeling of fullness, while reducing their food intake, hunger and cravings. This can help people lose weight.
Studies have shown that Wegovy is effective in helping people lose weight, with a significant proportion of them achieving at least a 5% weight reduction.
Three studies evaluated Wegovy given by injection in adults who had tried unsuccessfully to lose weight in the past and had a BMI of at least 30 kg/m2 or a BMI of at least 27 kg/m2 plus a weight-related health problem.
In the first study, involving 1,961 people, people treated with Wegovy were able to lose on average 15% of their weight after 68 weeks compared with a 2% loss of weight in people who had placebo (a dummy treatment). In addition, 84% of people in the Wegovy group were able to lose at least 5% of their weight compared with 31% of people in the placebo group.
In the second study, involving 611 people, those treated with Wegovy lost on average 16% of their body weight after 68 weeks compared with a 6% loss of weight in people who had placebo. Around 85% of people in the Wegovy group lost at least 5% of their weight compared with 48% of people in the placebo group. All participants in this study also received counselling to help them lose weight.
The third study, involving 902 people, looked at how the effects of Wegovy were maintained over the first 20 weeks. In this study, all participants had Wegovy for 20 weeks, after which some were stopped having Wegovy and were given placebo instead. After 48 more weeks, those who continued on Wegovy lost a further 8% of their weight while those on placebo regained 7% of theirs, indicating that people need to continue taking Wegovy in order not to regain weight.
A fourth study involved 1,210 adults with type 2 diabetes with a BMI of at least 27 kg/m2 and who had also tried unsuccessfully to lose weight in the past. After 68 weeks, those treated with Wegovy were able on average to lose 10% of their weight compared with a 3% weight loss in people who had placebo. In addition, 67% of people in the Wegovy group were able to lose at least 5% of their weight compared with 30% of people in the placebo group.
Another study involved 200 adolescents aged 12 to less than 18 years with a BMI at or above the 95th percentile (obesity) and 1 with a BMI at or above the 85th percentile (overweight) and at least one weight-related health problem. The study found that after 68 weeks, BMI dropped by an average of 16% in those treated with Wegovy compared with an average increase of less than 1% in those who received placebo. Around 73% of those who received Wegovy lost at least 5% of their weight compared with around 18% of those who received placebo.
In a study involving 307 adults who had obesity, or who were overweight and had at least one weight-related health problem, people taking Wegovy tablets for 64 weeks lost on average around 14% of their weight, compared with around 2% for those who received placebo. In addition, around 76% of people taking Wegovy tablets lost at least 5% of their weight, compared with around 31% of those who received placebo.
Studies carried out with Wegovy are described in more detail in the medicine’s assessment reports.
For the full list of side effects and restrictions of Wegovy, see the package leaflet.
The most common side effects with Wegovy (which may affect more than 1 in 10 people) include headache, nausea (feeling sick), vomiting, diarrhoea, constipations and abdominal (belly) pain.
Obesity can lead to severe health problems and many people with obesity have difficulty losing weight. Wegovy given by injection or as tablets is effective at reducing weight in adults with obesity or who are overweight with a weight-related health problem. It is also effective in adolescents with obesity when given by injection. There were not enough data to determine how effective Wegovy given by injection is in adolescents who are overweight. Wegovy tablets have not been studied in adolescents.
The medicine’s side effects are considered manageable. However, to prevent unnecessary long-term treatment, treatment should be stopped in adolescents who do not lose at least 5% of their weight within 12 weeks on the maximum dose or the maximum dose they can tolerate.
The European Medicines Agency therefore decided that Wegovy’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Wegovy have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Wegovy are continuously monitored. Suspected side effects reported with Wegovy are carefully evaluated and any necessary action taken to protect patients.
Wegovy received a marketing authorisation valid throughout the EU on 6 January 2022.
Product information
Latest procedure affecting product information:X/0000296344
14/07/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Wegovy
- Active substance
- semaglutide
- International non-proprietary name (INN) or common name
- semaglutide
- Therapeutic area (MeSH)
- Obesity
- Overweight
- Anatomical therapeutic chemical (ATC) code
- A10BJ06
Pharmacotherapeutic group
Antiobesity preparations, excl. diet productsTherapeutic indication
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.
For trial results with respect to cardiovascular risk reduction and populations studied, see section 5.1.
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.
*Obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1 in 4.1 of SmPC).
Table 1 BMI cut-off points for obesity (≥95th percentile) by sex and age for paediatric patients aged 12 and older (CDC criteria)
Assessment history
News on Wegovy
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