Reporter Chen Xing
On August 7th, Novo Nordisk announced its H1 2024 results that the Phase III OASIS 4 study on weight loss with oral semaglutide Rybelsus (25mg) has been successfully completed. Oral Smeaglutide (7mg and 14mg) was approved for marketing in the United States in September 2019, which is used as an auxiliary means of diet and exercise to help improve the blood sugar control of adult type 2 diabetes patients.
Rybelsus' breakthrough in weight loss indications will be an important development for oral GLP-1 preparations in the field of weight loss, and sales of semaglutide preparations are expected to further increase.
Successful Phase III study on oral administration of semaglutide for weight loss
The oral semaglutide Rybelsus (25mg), which has been approved as a hypoglycemic drug, has recently completed a phase III weight loss study.
On August 7th, Novo Nordisk announced its H1 2024 results that the Phase III OASIS 4 study on weight loss with oral semaglutide Rybelsus (25mg) has been successfully completed. This study included 307 cases with a body mass index (BMI) ≥ 27kg/m& sup2; And accompanied by at least one weight related complication (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) or BMI ≥ 30kg/m& sup2; The weight loss effect and safety of oral semaglutide (25mg, once daily) versus placebo were evaluated in overweight or obese adult subjects. The study lasted for 72 weeks, including a 1-week screening period, a 64 week treatment period, and a 7-week follow-up period.
The subjects in the oral semaglutide group received treatment in increasing doses over a period of 64 weeks, with a dose of 3mg taken from weeks 0-4, 7mg taken from weeks 5-8, 14mg taken from weeks 9-12, and 25mg taken from weeks 13-64. The primary endpoint of the study was the percentage change in body weight relative to baseline and the number of subjects who experienced a weight loss of at least 5% during the treatment period.
The baseline weight of the subjects was 105.9kg. The results showed that the weight loss of subjects in the oral semaglutide group was 13.6%, while the proportion in the placebo group was 2.2%. If all subjects persisted in completing the treatment, the weight loss in the oral semaglutide group was 16.6%, and the placebo group was 2.7%. In addition, oral semaglutide has shown good safety and tolerability in the study.
In September 2019, oral smeglutide (7mg and 14mg) was approved for marketing in the United States as an auxiliary means of diet and exercise to help improve the blood sugar control of adult type 2 diabetes patients. Meanwhile, the oral medication has been undergoing clinical research on weight loss indications.
In January this year, Novo Nordisk Megglutide Tablets (trade name: Novo Xin) was approved for marketing to treat type 2 diabetes, which is the first oral GLP-1 (glucagon like peptide-1) receptor agonist approved for marketing in China.
Terminate development of GLP-1/GIP dual receptor agonists once a month
According to the first half results released by Novo Nordisk, the sales of Ozempic, a hypoglycemic injection version of semaglutide, amounted to 56.685 billion Danish kroner, or 8.287 billion US dollars, a year-on-year increase of 36%; The sales revenue of Rybelsus, a hypoglycemic oral version of semaglutide, was 10.931 billion Danish kroner, equivalent to 1.598 billion US dollars, a year-on-year increase of 32%; The sales of the Simeglutide weight reducing version of Wegovy reached 21.036 billion Danish kroner, equivalent to 3.075 billion US dollars, a year-on-year increase of 74%.
The total sales revenue of the three products of Simeglutide is about 12.95 billion US dollars, further narrowing the gap with the global "King of Medicine" K drug's sales revenue of 14.217 billion US dollars. Rybelsus' breakthrough in weight loss indications will also be an important breakthrough for oral GLP-1 preparations in the field of weight loss, and sales are expected to further increase.
At the same time as announcing the results of Rybelsus' Phase III weight loss study, Novo Nordisk also disclosed that due to product portfolio considerations, Novo Nordisk has terminated the Phase I development of once monthly subcutaneous injection of GLP-1/GIP dual receptor agonists. In the layout of GLP-1/GIP, Novo Nordisk is still pushing forward with a weekly pipeline.
Tilpotide, a subsidiary of Eli Lilly, is currently the world's first and only approved glucose dependent insulinotropic polypeptide (GIP)/glucagon like peptide-1 (GLP-1) receptor agonist. In May 2022, Mounjaro, a hypoglycemic version of tilboptide, was approved for marketing in the United States; In November 2023, the weight loss version of Zepbound, also obtained approval from the US Food and Drug Administration (FDA) for marketing.
In July of this year, the indication for long-term weight management of Tilpotide Injection was approved by the National Medical Products Administration (NMPA). This is the second GLP-1 weight loss drug approved in China after Novo Nordisk Smiaglutide. At present, Tilpotide is also considered the biggest competitor of semaglutide.
In addition, Novo Nordisk has also halted the ongoing Phase I trials of VAP-1 inhibitors after the completion of the first part of the study evaluating their safety, tolerability, pharmacokinetics, and pharmacodynamics. Due to product portfolio considerations, the trial has been discontinued, and further development of VAP-1 inhibitors in metabolic associated steatohepatitis (MASH) has also been terminated.