Wegovy（semaglutide）欧洲公共评估报告：第 20 版修订，已获批

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.

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 95^th percentile (obesity) and 1 with a BMI at or above the 85^th 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.