｜Edited by the Content Team of Zhong Peptide BiochemicalAugust 7, 2024，Novo Nordisk announced the successful completion of the phase III OASIS 4 trial for weight loss with oral semaglutide Rybelsus (25mg) when releasing its H1 2024 financial results.
The study enrolled a total of 307 overweight or obese adult subjects with a body mass index (BMI) ≥27kg/m² and at least one weight-related complication (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease), or BMI ≥30kg/m². The weight loss efficacy and safety of oral semaglutide (25mg, once daily) versus placebo were evaluated. The study lasted for 72 weeks, including a 1-week screening period, a 64-week treatment period, and a 7-week follow-up period.Participants in the oral semaglutide group received treatment with dose escalation over 64 weeks: 3mg dose from weeks 0-4, 7mg dose from weeks 5-8, 14mg dose from weeks 9-12, and 25mg dose from weeks 13-64. The primary endpoints of the study were the percentage change in body weight from baseline during the treatment period and the number of participants who achieved at least a 5% reduction in body weight.The baseline weight of the subjects was 105.9kg. The results showed that the weight of subjects in the oral semaglutide group decreased by 13.6%, while the proportion in the placebo group was 2.2%. If all subjects had completed the treatment, the weight loss in the oral semaglutide group would be 16.6%, and the placebo group would be 2.7%. In addition, oral semaglutide showed good safety and tolerability in the study.Previously, an oral semaglutide weight loss Phase III study had reached its primary endpoint. In May 2023, the Phase III OASIS 1 study of oral semaglutide 50mg for weight loss was successfully completed. The results showed that after 68 weeks of treatment, patients in the semaglutide group lost 17.4% of their body weight, with 89.2%, 74.7%, 58.5%, and 37.2% of patients losing at least 5%, 10%, 15%, and 20% of their body weight, respectively.
Among them, the PIONEER PLUS study evaluated the glucose-lowering effects of oral semaglutide at doses of 14/25/50mg. In July this year, based on the positive results of the PIONEER PLUS study, the marketing application for oral semaglutide (25/50mg) received a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). Novo Nordisk expects the European Commission (EC) to make an approval decision within two months.
Semaglutide is a GLP-1 receptor agonist that stimulates insulin production, inhibits glucagon secretion, and reduces appetite and food intake. Semaglutide was initially developed as a treatment for type 2 diabetes.ApprovedLaunched (Trade Name: Ozempic), in view of its significant effect on weight loss, the FDA in June 2021ApprovalIt is used to treat ordinary obese patients (trade name: Wegovy), which is the first new drug approved by the US FDA for controlling common obesity or overweight since 2014. The drug was subsequently approved by the EU for the treatment of obesity indications later in the same year.AboutNovo Nordisk
Novo Nordisk, founded in 1923, is a global leading biopharmaceutical company headquartered in Copenhagen, the capital of Denmark. Our goal is to drive change to defeat diabetes and other serious chronic diseases such as obesity, rare blood disorders, and endocrine disorders. To achieve this, we lead scientific breakthroughs, expand the accessibility of our medicines, and are committed to preventing and ultimately curing these diseases. Novo Nordisk has approximately 47,000 employees across 80 countries and regions worldwide and provides products and services to more than 168 countries and regions globally.
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