Semaglutide is a glucagon-like peptide 1 (GLP-1) analog used to manage type 2 diabetes along with lifestyle changes, such as dietary restrictions and increased physical activity. Other members of this drug class include Exenatide and Liraglutide. Semaglutide was developed by Novo Nordisk and approved by the FDA for subcutaneous injection in December 2017. The tablet formulation was approved for oral administration in September 2019. Semaglutide works by binding to and activating the GLP-1 receptor, thereby stimulating insulin secretion and reducing blood glucose.
The subcutaneous injection is administered once weekly and the tablet is administered once a day. Semaglutide offers a competitive advantage over other drugs used to manage diabetes, which may require several daily doses. Clinical trials have determined that this drug reduces glycosylated hemoglobin (HbA1c) levels and reduces body weight, proving to be effective for patients with type 2 diabetes. In June 2021, semaglutide was approved by the FDA for chronic weight management in adults with general obesity or overweight who have at least one weight-related condition, marking semaglutide as the first approved drug for such use since 2014. The use of semaglutide in weight management is also approved by Health Canada and the EMA.
On May 31, 2023, the FDA issued a warning regarding the use of compounded semaglutide after receiving adverse event reports. The use of salt forms of semaglutide, including semaglutide sodium and semaglutide acetate, has not been proven to be safe or effective.
Semaglutide is indicated to improve glycemic control in adults diagnosed with type 2 diabetes mellitus, and is used as an adjunct to diet and exercise. However, semaglutide is not a suitable first-line drug for diabetes that has not been controlled by diet and exercise. In addition, it has not been studied in patients with pancreatitis. Semaglutide is not intended for use in patients with type 1 diabetes or to treat diabetic ketoacidosis.
Semaglutide is indicated for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced-calorie diet and increased physical activity.. Semaglutide it is also indicated for chronic weight management in pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and sex.
Novo Nordisk Investigational Site, Yerres, France
Novo Nordisk Investigational Site, Olympia, Washington, United States
Novo Nordisk Investigational Site, Álava, Spain
Clinical Trials Unit / Center for Medical Research, Graz, Austria
CTC Clinical Trial Consultants AB, Uppsala, Uppsala, Sweden
Steno Diabetes Center Copenhagen, Herlev, Denmark
Novo Nordisk Investigational Site, Zhytomyr, Ukraine
Texas Clinical Research Institute, LLC, Arlington, Texas, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Miami/Schiff Center for Liver Diseases, Miami, Florida, United States
PharmQuest, Greensboro, North Carolina, United States
Aventiv Research Inc, Columbus, Ohio, United States
Biopharma Informatic, Inc., Houston, Texas, United States
Cedars Sinai Medical Center, Los Angeles, California, United States
Institute for Liver Health - Arizona Liver Health, Chandler, Arizona, United States
Quality Medical Research, PLLC, Nashville, Tennessee, United States
Profil Institut für Stoffwechselforschung, Neuss, Nordrhein-Westfalen, Germany
Profil Mainz GmbH & Co. KG, Mainz, Rheinland-Pfalz, Germany
Novo Nordisk Investigational Site, Zwijndrecht, Netherlands
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