Home > News > Key clinical studies and marketing progress of Semaglutide
Aug.2023 14
Views: 133
Key clinical studies and marketing progress of Semaglutide
Introduction
Key clinical studies and marketing progress of Semaglutide
Details
In September 2019, the US FDA approved the marketing of Semaglutide tablets, under the trade name RYBELSUS, for use as an adjuvant to diet and exercise to improve blood sugar control in adults with type 2 diabetes, with a starting dose of 3mg and a maintenance dose of 7mg or 14mg once daily. One of the restrictions on its use is that it is not recommended as a first-line treatment for patients with insufficient diet and exercise (Note: FDA removed this restriction in January 2023). The drug was approved based on the PIONEER 1-10 global clinical trial, which enrolled 9543 patients with type 2 diabetes. Compared with the control group, oral sommarlutide reduced the patients' HbA1c level and body weight, and the oral Semaglutide reduced body weight by 2.0-5.0kg. It has been shown to be safe and well tolerated in clinical trials. On June 4, 2021, the official website of the United States FDA announced that semaglutide (brand name Wegovy) injection (2.4 mg, once a week) was officially approved for chronic weight management in obese or overweight adults.
The approval is based on the results of Phase IIIa of the STEP clinical program. In a trial in a non-diabetic population involving more than 4,500 obese or overweight adults without type 2 diabetes, obese patients treated with Semaglutide lost an average of 17-18% of their body weight over 68 weeks, and the trial was shown to be safe and well tolerated.
