All four trials of the No. and Nord agitant Weight Loss Phase III STEP project were successful

and Novo Nordisk recently announced the top-line results of the last two Phase IIIa clinical trials (STEP 2, STEP 3) in the Semaglutide Weight Loss Efficacy Phase III STEP project. Among them, the STEP 2 trial was conducted in adult patients with type 2 diabetes (T2D) and obesity/overweight; The results showed that a weekly dose of semaglutide of 2.4 mg of semaglutide resulted in a statistically significant reduction in body weight compared to comfort.Semaglutide (Somaglutide) is a human glucosin-like peptide-1 (GLP-1) similar, with glucose concentration dependence mechanism to promote insulin secretion and inhibit gluatic glucosin secretion, can make type 2 diabetes patients blood sugar levels significantly improved, and the risk of hypoglycemia is low. In addition, semaglutide can induce weight loss by reducing appetite and food intake. In addition, semaglutide significantly reduces the risk of major cardiovascular events (MACEs) in people with type 2 diabetes.Obesity is a chronic disease that requires long-term treatment and is associated with many serious health consequences and reduced life expectancy. Obesity-related complications include type 2 diabetes, heart disease, obstructive sleep apnea, chronic kidney disease, non-alcoholic fatty liver disease, and cancer.Noor and Nord are studying the weekly SC Semaglutide 2.4mg as a treatment for obesity in adults. Semaglutide is a GLP-1 hormone-liker that induces weight loss by helping people eat less and eat fewer calories by reducing hunger and satiety.The STEP Project (Semaglutide's Treatment effects in obese populations) is a Phase III clinical development project that evaluates the weight management of adult obese patients at a weekly dose of semaglutide 2.4 mg. The Global Clinical Phase IIIa program consists of four Phase IIIa trials in which approximately 4,500 overweight or obese adults have been included.The project uses two statistical methods: (1) treatment strategy-based assessment (primary statistical method), i.e. treatment effectiveness without considering treatment compliance or enabling other weight loss drugs;


following is a summary of data from four clinical trials in the project, in reverse order of the time of reporting.STEP 2 (Obesity plus Type 2 Diabetes) STEP 2 (Obesity and Type 2 Diabetes) was a 68-week, randomized, double-blind, multi-center, placebo-controlled trial that included 1,210 people with type 2 diabetes and obesity Adult patients who were overweight compared the efficacy and safety of weight loss at 68 weeks of weekly SC semaglutide 2.4mg, placebo, and weekly SC semaglutide 1.0mg treatment, with each treatment group combined with lifestyle interventions.The trial reached two main endpoints, with statistically significant differences: , the main statistical method showing that after 68 weeks of treatment in all randomized patients, the SC Semaglutide 2.4mg treatment group dropped 9.6% from an average baseline weight of 99.8 kg, the placebo group lost 3.4%, and the SCema sglutide 1.0mg group lost 7.0% of their body weight. After 68 weeks of treatment, 68.8 percent of patients in the SC semaglutide 2.4 mg group lost ≥5 percent of their body weight and 28.5 percent in the placebo group.Secondary statistical methods showed that after 68 weeks of intentional treatment, the SC semaglutide 2.4mg treatment group lost 10.6%, the placebo group lost 3.1%, and the SC Semaglutide 1.0mg group lost 7.5%. After 68 weeks of treatment, 73.2% of patients in the SC semaglutide 2.4mg group lost ≥5% of their body weight and 27.6% in the placebo group.STEP 3 (Auxiliary Intensive Behavioral Therapy (IBT)) STEP 3 (Auxiliary Enhanced Behavioral Therapy (IBT)) was a 68-week, randomized, double-blind, multi-center, placebo-controlled trial with 611 cases of comorbation. For obese or overweight adult patients, the efficacy and safety of weight loss were compared to the weekly SC semaglutide 2.4mg with placebo treatment for 68 weeks, and both treatment groups were combined with IBT, defined as weekly behavioral support, dietitian counseling, and a low-calorie diet.The trial reached two main endpoints, with statistically significant differences: , the main statistical method showing that after 68 weeks of treatment in all randomized patients, the SC Semaglutide 2.4mg-IBT treatment group dropped 16.0% from an average baseline weight of 105.8 kg, and the placebo-IBT group lost 5.7% of its body weight. After 68 weeks of treatment, 86.6 percent of patients in the SC semaglutide 2.4mg-IBT group lost ≥5 percent of their body weight and 47.6 percent in the placebo-IBT group.Secondary statistical methods showed that after 68 weeks of treatment, the SC semaglutide 2.4mg-IBT treatment group lost 17.6% of their body weight and the placebo-IBT group lost 5.0% of their body weight. After 68 weeks of treatment, 89.8 percent of patients in the SC semaglutide 2.4mg-IBT group lost ≥5 percent of their body weight and 50.0 percent in the placebo group.STEP 4 (Random Withdrawal) STEP 4 (Withdrawal) was a 68-week, randomized, double-blind, multi-center, placebo-controlled, withdrawal trial that included 902 obese or overweight patients with combined disorders, comparing the efficacy and safety of semaglutide and placebo for continuous weight management. The trial consists of a 20-week import period (run-in) and a 48-week maintenance period. During the 20-week introduction period, 803 patients achieved the target dose of 2.4 mg after receiving an incremental dose of semaglutide, reducing their average weight from 107.2 kg to 96.1 kg. The patients then entered the maintenance period, randomly divided into two groups, one receiving SC semaglutide 2.4mg once a week and the other receiving sC placebo once a week for 48 weeks.The trial reached two main endpoints, and the data showed statistically significant differences, showing that patients who continued to receive SC semaglutide 2.4 mg had a further significant drop in weight, while those who switched to a placebo had a significant recovery in weight.The main statistical methods showed that in all randomized patients who continued to receive SC semaglutide 2.4mg for 48 weeks, the average weight continued to decrease by 7.9% from the baseline at the time of randomization (the weight at the end of the import period), while in patients receiving a placebo, the average weight increased by 6.9% from the baseline at the time of randomization. The differences in treatment in 2 groups were statistically significant. Patients who received weekly SC semaglutide treatment for 68 weeks (20 weeks of introduction and 48 weeks of maintenance) lost an average of 17.4% of their body weight.Secondary statistical methods showed that in patients with intentional therapy, patients who continued to receive SC Semaglutide 2.4mg for 48 weeks continued to lose 8.8% of their average weight from the baseline at the time of randomization (the weight at the end of the import period), while those receiving placebo continued to lose 6.5% of their average weight from the baseline at the time of randomization. The differences in treatment in 2 groups were statistically significant. Patients who received weekly SC semaglutide treatment for 68 weeks lost an average of 18.2% of their body weight. STEP 1 (Auxiliary Lifestyle Intervention) STEP 1 (Auxiliary Lifestyle Intervention) was a 68-week, randomized, double-blind, multi-center, placebo-controlled trial that included 1,961 obese or overweight patients with combined disorders, comparing the efficacy and safety of weight loss at 2.4 mg or placebo treatment once a week, and 2 with lifestyle interventions. The trial reached two main endpoints, with statistically significant differences in data showing that SC semaglutide 2.4 mg showed statistically significant and better weight reductions after 68 weeks of treatment than placebo. The main statistical methods showed that after 68 weeks of treatment in all randomized patients, the SC semaglutide 2.4mg treatment group decreased by 14.9% from the average baseline weight of 105.3 kg, the placebo group lost 2.4%, and the SC semaglutide 2.4mg group lost 86.4% of the patients≥ Secondary statistical methods showed that after 68 weeks of treatment, the SC semaglutide 2.4mg treatment group lost 16.9% of their body weight, the placebo group lost 2.4%, and the SC Semaglutide 2.4mg group lost ≥5% of their body weight and 33.1% of the placebo group. In four trials, SC semaglutide 2.4mg was safe and well-to-bear, consistent with previous trials. The most common adverse event in patients treated with SC semaglutide 2.4 mg was gastrointestinal events. Most events are short-lived and mild or moderate in severity. Mads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer, said, "The results of STEP 2 and STEP 3 continue to build on the impressive weight loss results reported in previous STEP 1 and STEP 4 trials. Overall, the results suggest that semaglutide 2.4mg will play a key role in improving the treatment of obese patients. We have now reported all four trials in the STEP project and look forward to sharing these results with regulators. , Novo Nord has developed injection preparations (Ozempic) and oral preparations (Rybelsus): - Ozempic (semaglutide, injection preparations): weekly subdern injection preparations (0. 5 mg or 1 mg), suitable for: (1) as an aid of dietary adjustment and exercise to improve blood sugar control in adults with type 2 diabetes, (2) for adults with type 2 diabetes with cardiovascular disease (CVD), reducing the risk of major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal heart attack, non-fatal stroke). Ozempic was first approved by the FDA in December 2017 and is now available in many countries and regions around the world. The drug's second adaptive disorder was approved by the FDA in January 2020, and data from the Cardiovascular Outcome Trial (CVOT) SUSTAIN 6 show that in patients with type 2 diabetes at high cardiovascular (CV) risk, Ozempic statistically reduced the risk of MACE compound endpoints by 26% compared to placebo when combined with standard care. - Rybelsus (semaglutide, oral tablet): A daily oral preparation containing the absorbent exonerate SNAC, which is suitable for improving blood sugar control in adults with type 2 diabetes as a dietary adjustment and exercise and ancillary drug. Rybelsus is the world's first and only oral GLP-