The European Commission has approved the updated summary of product characteristics (SmPC) for Wegovy (semaglutide) with new data from the STEP UP clinical trial, which evaluated higher doses of the drug for treating obesity. This decision consolidates the use of a maintenance dose of 7,2 mg per week , three times higher than the currently marketed dose of 2,4 mg, which has been shown to achieve weight loss of approximately 21% in people with obesity. The measure also reinforces the role of treatments in the pharmacological management of obesity from both a regulatory and clinical safety perspective.
With this regulatory update, all European Union countries , including Spain, incorporate the evidence from STEP UP into their product information sheets, allowing physicians to implement more intensive weight-loss strategies in selected patients. This measure builds upon the previous favorable opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and reinforces the role of semaglutide as a key tool in the pharmacological treatment of obesity.
A dose of 7,2 mg achieves a weight loss of around 21%.
Data from the STEP UP program shows that, with the new 7,2 mg dose administered once a week , people with obesity but without diabetes lost an average of approximately 21% of their body weight after 72 weeks of treatment, always accompanied by recommendations for a healthy diet and increased physical activity. In practical terms, as endocrinologist Josep Vidal illustrated, this represents "about 23 kilos less for someone starting at 100 kilos," reflecting the real impact on patients' daily lives.
In addition to the overall figure, the results indicate that approximately one in three people treated with 7,2 mg achieve a weight loss of 25% or more. This is a percentage of weight loss that, until recently, was almost exclusively associated with bariatric surgery . The comparison with the 2,4 mg dose is particularly striking, as researchers highlight that these new figures practically triple the results obtained with the standard dose in terms of the proportion of patients achieving such significant weight reductions.
In the STEP UP trial, which involved more than 1.400 people with obesity but without diabetes, patients treated with a placebo lost only about 2% of their weight, compared to the 21% observed with semaglutide 7,2 mg. The clinical difference between the two groups highlights the power of the new regimen, always within the context of structured medical follow-up and lifestyle changes.
The European Commission has translated these results into practice by authorizing healthcare professionals to prescribe the higher dose— three 2,4 mg injections administered in the same weekly session—until a specific 7,2 mg formulation becomes available. At the same time, Novo Nordisk has applied for approval of a 7,2 mg single-dose pen, which could simplify administration when it becomes available on the European market.
Fat reduction, muscle preservation, and cardiovascular benefits
Beyond the number on the scale, researchers have analyzed the quality of weight loss . Data from STEP UP indicate that approximately 84% to 85% of the weight lost with the 7,2 mg dose comes from fat mass, while muscle mass loss remains within acceptable limits for people with obesity. This analysis of the quality of weight loss provides insight into the actual functional benefits for patients.
In clinical practice, this translates into an improvement in body composition. As Josep Vidal explained, in the functional tests performed during the study, such as the number of times patients were able to stand up and sit down from a chair in 30 seconds, muscle function not only did not worsen , but even improved slightly. This finding is relevant for those who fear that a rapid or very intense loss of muscle mass could impair strength or physical capacity.
In addition to these effects on weight and body composition , semaglutide at a dose of 2,4 mg offers the well-known cardiovascular benefits . Previous evidence has shown a reduction in the risk of major cardiovascular events , including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, as well as improvements in symptoms of heart failure with preserved ejection fraction and a reduction in knee osteoarthritis pain . The updated product information now integrates this data with that of the higher dose, reinforcing the drug's position as a long-term option for patients with obesity and associated comorbidities.
According to Francisco Pajuelo, Medical Director of Novo Nordisk Spain, all of this translates into "quality weight loss ," combining a substantial reduction in weight, improved body composition, and a potential positive impact on other common health problems in these individuals. In his opinion, having higher doses available allows for greater flexibility in adjusting therapeutic goals according to each patient's profile and needs.
Meanwhile, specialists like endocrinologist Diego Bellido emphasize that obesity should be addressed as a chronic disease , with long-term treatments and relapse prevention strategies. Weight loss is only one part of the process: maintaining it and preventing the recurrence of associated complications requires a long-term plan that combines medication, nutritional education, regular exercise, and ongoing support.
Safety and side effects with the new dose
One of the aspects most closely monitored in STEP UP was whether increasing the dose to 7,2 mg would lead to an increase in adverse effects . The results indicate that the safety and tolerability profile of semaglutide at high doses remains consistent with what is already known for GLP-1 receptor agonists, and in particular, for the 2,4 mg dose.
The most frequent adverse events were gastrointestinal: nausea, vomiting, diarrhea, constipation, and, in some cases, abnormal sensations such as dysesthesia. In most patients, these symptoms were mild to moderate in intensity and, above all, transient , concentrated in the initial stages of dose escalation. According to experts, the increase from 2,4 mg to 7,2 mg did not result in a significant increase in the number or severity of these side effects.
This safety profile, according to clinicians, allows for the use of the 7,2 mg dose in patients who, after an adequate period with 2,4 mg, do not reach their weight goals or require a more significant reduction to better control their associated complications. The available evidence supports that the dose can be increased without, in general, a significant worsening of tolerability.
At the same time, specialists remind us that the decision to increase the dose should always be made on a case-by-case basis , weighing the balance between expected benefits and potential adverse effects, and ensuring close monitoring during the first few weeks of adjustment.
In people with type 2 diabetes, current experience suggests that increasing the dose to 7,2 mg does not provide a clear additional improvement in glycemic control compared to 2,4 mg, although it may promote greater weight loss. Therefore, the use of the higher dose in this patient group is primarily intended for those with significant obesity or comorbidities for whom greater weight loss is particularly important.
Personalization of treatment and the role of lifestyle habits
With the updated product information, doctors across the EU now have a clear regulatory framework to more precisely tailor Wegovy's dosage to each patient. According to Vidal, the most common approach is to begin therapy with the usual dose escalation until reaching 2,4 mg per week, and if the weight loss response is insufficient, consider increasing to 7,2 mg.
This flexibility is part of a personalized treatment strategy , also highlighted by Diego Bellido. Not all people with obesity require the same therapeutic intensity : some can achieve reasonable goals with the standard dose, while others, due to their degree of obesity or the presence of multiple associated diseases, may benefit from a more potent pharmacological intervention.
In clinical practice, this means that the professional must decide not only whether to use Wegovy, but also what dose and for how long , integrating the treatment into a comprehensive plan that includes dietary changes, increased physical activity, and psychological or behavioral support when necessary. The regulatory update does not replace this comprehensive approach, but rather adds another tool to adapt to the circumstances of each case.
Experts emphasize that obesity doesn't magically disappear once a target weight is reached. If medication is discontinued prematurely and the patient doesn't maintain reasonably healthy lifestyle habits, the risk of regaining some or all of the lost weight is high. Hence the importance of combining medication with structured nutritional education, tailored exercise programs, and ongoing medical monitoring.
As the president of the Spanish Society for the Study of Obesity (SEEDO) points out, treating this disease “with the same seriousness as diabetes or other chronic conditions” is key to reducing complications, mortality, and healthcare costs in the long term . Medication, in this context, is a significant aid, but it does not replace the need to commit to sustained lifestyle changes.
Situation in Spain and next steps in Europe
With the European Commission's decision, all member states immediately incorporate the data for the 7,2 mg dose into the Wegovy product information. This means that, in Spain, any physician specializing in obesity management can now prescribe the higher dose, always within the approved indications and after carefully evaluating each patient.
From Novo Nordisk Spain, Medical Director Francisco Pajuelo explained that, although the 7,2 mg dose can already be prescribed by combining several injections, there is still no specific commercial presentation with that amount in a single pen. The company is working to make this presentation available on the Spanish and European markets in the short term, which would prevent patients from having to administer several doses in the same weekly session.
In parallel, the company has also applied for authorization in Europe for the oral formulation of semaglutide for weight management, an option already available in the United States . If approved, European patients could have both injectable and oral alternatives within the same drug class, further expanding the possibilities for personalized treatment based on individual preferences and characteristics.
Currently, in the European market, Wegovy is available in six injectable doses (0,25 mg, 0,5 mg, 1,0 mg, 1,7 mg, 2,4 mg, and 7,2 mg), allowing for a gradual dose increase to reach the most appropriate maintenance level. The aim is to minimize side effects during dose escalation while offering a broad range of dosages to suit a wide variety of clinical situations.
At the national level, the debate centers not only on access to and funding of the drug, but also on how to integrate it into structured healthcare pathways for obesity, which include the coordinated participation of primary care, endocrinology, nutrition, psychology, and other relevant professionals. The arrival of higher doses once again highlights the need to strengthen these comprehensive care models.
With the European approval of the 7,2 mg dose of Wegovy and the incorporation of data from the STEP UP program into its product information, the pharmacological treatment of obesity in Spain and the rest of the EU is entering a new phase. In this new era, it is now possible to achieve sustained weight reductions of around 21% , with the loss primarily focused on fat mass, while maintaining a known safety profile. The challenge now will be to use this tool responsibly, integrated into a comprehensive, long-term approach that allows people with obesity to improve their health and maintain these results over time.
