Semaglutide: Safety Profile & Research Summary
Research Summary
Landmark Clinical Trials
| Trial | N | Key Finding | Ref |
|---|---|---|---|
| SUSTAIN-6 | 3,297 | 26% MACE reduction vs placebo in T2D | [3] |
| STEP 1 | 1,961 | 14.9% body weight loss (2.4 mg/wk) vs 2.4% placebo | [4] |
| SELECT | 17,604 | 20% MACE reduction in overweight/obese without diabetes | [5] |
| FLOW | 3,533 | 24% reduction in kidney disease progression in T2D + CKD | [6] |
| PIONEER 6 | 3,183 | Oral semaglutide non-inferior for CV safety | [9] |
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About This Research Profile
This research profile was compiled from peer-reviewed sources including the New England Journal of Medicine, The Lancet, and regulatory documents. ALL ARTICLES AND PRODUCT INFORMATION PROVIDED ON THIS WEBSITE ARE FOR INFORMATIONAL AND EDUCATIONAL PURPOSES ONLY.
References
- Lau J, Bloch P, Schäffer L, et al. Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide. Journal of Medicinal Chemistry, 58(18), 7370-7380, 2015.
- Kapitza C, Nosek L, Jensen L, Hartvig H, Jensen CB, Flint A. Semaglutide, a once-weekly human GLP-1 analog, does not reduce the bioavailability of the combined oral contraceptive ethinylestradiol/levonorgestrel. Journal of Clinical Pharmacology, 55(5), 497-504, 2015.
- Marso SP, Bain SC, Consoli A, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. New England Journal of Medicine, 375(19), 1834-1844, 2016.
- Wilding JPH, Batterham RL, Calanna S, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1). New England Journal of Medicine, 384(11), 989-1002, 2021.
- Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT). New England Journal of Medicine, 389(24), 2221-2232, 2023.
- Perkovic V, Tuttle KR, Rossing P, et al. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes (FLOW). New England Journal of Medicine, 391(2), 109-121, 2024.
- Newsome PN, Buchholtz K, Cusi K, et al. A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. New England Journal of Medicine, 384(12), 1113-1124, 2021.
- Knop FK, Aroda VR, do Vale RD, et al. Oral semaglutide 50 mg taken once daily in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet, 402(10403), 705-719, 2023.
- Husain M, Birkenfeld AL, Donsmark M, et al. Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes (PIONEER 6). New England Journal of Medicine, 381(9), 841-851, 2019.
- Davies M, Pieber TR, Hartoft-Nielsen ML, Hansen OKH, Jabbour S, Rosenstock J. Effect of Oral Semaglutide Compared With Placebo and Subcutaneous Semaglutide on Glycemic Control in Patients With Type 2 Diabetes (PIONEER 7). JAMA, 321(15), 1466-1480, 2019.
- Rubino D, Abrahamsson N, Davies M, et al. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity (STEP 4). JAMA, 325(14), 1414-1425, 2021.
- Wadden TA, Bailey TS, Billings LK, et al. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity (STEP 3). JAMA, 325(14), 1403-1413, 2021.
Related Research Questions
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This content is provided for educational and informational purposes only. Products are furnished for in-vitro studies only and are not medicines, drugs, or supplements. Not approved by the FDA to prevent, treat, or cure any condition.