Semaglutide is well known in the field of weight loss, but the long-term effectiveness of its weight loss effect has always been one of the topics of concern in the industry and the public.
Maintain an average weight loss of 10.2% for four years
Recently, at the European Obesity Conference held in Italy, Novo Nordisk announced the results of two studies showing that after 4 years of continuous treatment with the semaglutide weight-loss drug Wegovy, overweight and obese patients with heart disease but no diabetes can still maintain meaningful weight, and no matter how much weight is lost, cardiovascular health has improved.
It is understood that the two studies announced this time are based on the analysis results of the large-scale phase III clinical study SELECT. The SELECT trial enrolled 17,604 adults with overweight or obesity from 41 countries who were treated with either 2.4 mg Wegovy or placebo subcutaneously once weekly. These patients have had a prior history of heart disease, stroke, and/or peripheral arterial disease, but have not developed type 1 or type 2 diabetes.
The first study, published in the Monday issue of Nature Medicine, followed patients in the Novo Nordisk SELECT Cardiovascular Outcomes Study for 208 weeks and found that patients treated with Wegovy maintained their initial weight during that time. Specifically, patients in the Wegovy group continued to lose weight for 65 weeks, and they were able to maintain weight over a period of 4 years. On average, patients in the Wegovy group lost 10.2% of their body weight, compared to only 1.5% in the placebo group, and the difference in treatment between the two groups was a statistically significant 8.7%.
It is worth mentioning that the results of the 104-week study also showed that 52% of patients treated with Wegovy had a lower body mass index (BMI) after two years, compared to 16% in the placebo group, for example, the proportion of obese patients (BMI≥30 kg/m²) in the Wegovy group decreased from 71% to 43%, while the placebo group decreased from 72% to 68%. In addition, 12% of patients in the Wegovy group achieved a healthy weight (BMI≤25 kg/m²), compared to only 1.2% in the placebo group.
Donna Ryan, a professor at the Pennington Center for Biomedical Research in New Orleans, USA, who is also lead author of the study, said: "Observing this level of weight loss in such a large and diverse population suggests that Wegovy may have the potential to influence the public health burden of multiple obesity-related diseases. While our trial focused on cardiovascular events, many other chronic diseases, including several types of cancer, osteoarthritis, and anxiety and depression, among others, may also benefit from effective weight management. ”
The second study, presented at the European Conference on Obesity, revealed the relationship between weight change and cardiovascular outcomes.
The results showed that Wegovy treatment improved cardiovascular outcomes regardless of the patient's starting weight and weight loss. These findings suggest that even mildly obese people, or those who have lost only a small amount of weight, can still reap clinical benefits from Wegovy.
John Deanfield, professor of cardiology at University College London and leader of the second study, said: "These results suggest that Wegovy has other effects in reducing cardiovascular risk in addition to reducing unhealthy body fat". John Deanfield adds: "Wegovy may also have 'direct effects' on the heart and blood vessels, such as lowering blood pressure, blood sugar levels or inflammation."
In terms of safety, the Wegovy group had a lower percentage of serious adverse events compared to the placebo group, at 33% and 36%, respectively, mainly due to differences in heart disease. But more patients treated with Wegovy stopped the trial due to gastrointestinal symptoms, including nausea and diarrhoea, mainly during the 20-week dose-escalation phase. In addition, the incidence of gallstones was higher in the Wegovy group.
However, the study authors caution that SELECT is not a primary prevention trial and that data "should not be extrapolated to all overweight and obese individuals" to prevent major adverse cardiovascular events. They also noted that the dataset "does not have the number of individuals in ethnic subgroups, and the number of individuals in such groups may reveal potential differential effects." “
The indication for weight loss is expected to be approved in China this year
Needless to say, the above research results will undoubtedly bring benefits to Novo Nordisk again, after all, the long-term stability of weight loss effect is one of the important factors for every obese person to consider. Novo Nordisk is currently trying to convince insurers and governments to reimburse Wegovy for treatment, and this data will help strengthen its positioning as a medical necessity to fight for wider insurance coverage and government support. Despite not covering health insurance on a large scale, in the first quarter of this year, Wegovy continued its hot trend, which was reflected in its sales performance, selling 9.377 billion DKK, an increase of 107% year-on-year. With the approval of weight-loss indications in more countries and regions, it is only natural that Wegovy will usher in a faster market expansion.
In the Chinese market, Novo Nordisk said at an investor conference that semaglutide, a drug for weight loss, is expected to be approved for marketing in the mainland this year, and the indication submitted a marketing application to the NMPA in June 2023, but the initial marketing is dominated by self-financed patients and the supply is limited.
In addition, in April this year, Novo Nordisk also submitted a clinical trial application for its other weight-loss drug Amycretin tablets in the Chinese market, which is a long-acting combination agonist of oral GLP-1 receptor and amylin receptor, which is administered as subcutaneous therapy once a week or oral therapy once a day. According to a small phase 1 clinical study published by Novo Nordisk, patients lost an average of 13.1% of their body weight after 12 weeks of treatment with the drug, which exceeded the 6% weight loss efficacy of the previous version of semaglutide in the same cycle.
In addition to the effect, the long-term effect of weight loss has become one of the focuses of the giants in the next stage. A few days ago, Amgen released data related to its weight-loss therapy MariTide, a small early clinical trial showed that patients who took Amgen's highest dose of 420 mg lost an average of 14.5% weight in 12 weeks. In contrast to currently marketed drugs, MariTide appears to help patients maintain weight loss for a longer period of time after discontinuation of the drug. In addition, due to the monoclonal antibody components it contains, MariTide may be administered less frequently than existing drugs, with injections once a month, making it more convenient for patients to use. Driven by the news, Amgen's stock price soared pre-market, hitting a record high at one point.