Semaglutide 2.4mg for Low Responders After Bariatric Surgery
Summary
In 20 - 30% of the patients, the low responders, sufficient weight loss is not achieved after bariatric surgery. Secondary and/or tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high. Therefore, additional pharmacotherapy has been suggested. Semaglutide is one of the medications that might improve outcome in the post-bariatric population. Semaglutide is a Glucagon-like peptide-1 (GLP-1) receptor analogue developed to treat type 2 diabetes. It causes glucose-dependent insulin secretion, promotes satiety and inhibits glucagon secretion. In obese (non-bariatric) patients, semaglutide has shown to improve glycemic control, decrease blood pressure, lower cardiovascular risk, and decrease body weight.
Timeline
- Start
- 2024-05
- Primary completion
- 2026-02
- Completion
- 2026-09
Publications
- Background Yumuk V, Tsigos C, Fried M, Schindler K, Busetto L, Micic D, Toplak H; Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015;8(6):402-24. doi: 10.1159/000442721. Epub 2015 Dec 5.
- Background Bray GA, Fruhbeck G, Ryan DH, Wilding JP. Management of obesity. Lancet. 2016 May 7;387(10031):1947-56. doi: 10.1016/S0140-6736(16)00271-3. Epub 2016 Feb 10.
- Background Busetto L, Dicker D, Azran C, Batterham RL, Farpour-Lambert N, Fried M, Hjelmesaeth J, Kinzl J, Leitner DR, Makaronidis JM, Schindler K, Toplak H, Yumuk V. Practical Recommendations of the Obesity Management Task Force of the European Association for the Study of Obesity for the Post-Bariatric Surgery Medical Management. Obes Facts. 2017;10(6):597-632. doi: 10.1159/000481825. Epub 2017 Dec 6.
- Background Apovian CM, Aronne LJ, Bessesen DH, McDonnell ME, Murad MH, Pagotto U, Ryan DH, Still CD; Endocrine Society. Pharmacological management of obesity: an endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015 Feb;100(2):342-62. doi: 10.1210/jc.2014-3415. Epub 2015 Jan 15.
- Background Nuffer W, Trujillo JM, Megyeri J. A Comparison of New Pharmacological Agents for the Treatment of Obesity. Ann Pharmacother. 2016 May;50(5):376-88. doi: 10.1177/1060028016634351. Epub 2016 Feb 17.
- Background Madsbad S, Dirksen C, Holst JJ. Mechanisms of changes in glucose metabolism and bodyweight after bariatric surgery. Lancet Diabetes Endocrinol. 2014 Feb;2(2):152-64. doi: 10.1016/S2213-8587(13)70218-3. Epub 2014 Feb 3.
- Background Sjostrom L. Review of the key results from the Swedish Obese Subjects (SOS) trial - a prospective controlled intervention study of bariatric surgery. J Intern Med. 2013 Mar;273(3):219-34. doi: 10.1111/joim.12012. Epub 2013 Feb 8.
- Background Gloy VL, Briel M, Bhatt DL, Kashyap SR, Schauer PR, Mingrone G, Bucher HC, Nordmann AJ. Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials. BMJ. 2013 Oct 22;347:f5934. doi: 10.1136/bmj.f5934.
- Background Reges O, Greenland P, Dicker D, Leibowitz M, Hoshen M, Gofer I, Rasmussen-Torvik LJ, Balicer RD. Association of Bariatric Surgery Using Laparoscopic Banding, Roux-en-Y Gastric Bypass, or Laparoscopic Sleeve Gastrectomy vs Usual Care Obesity Management With All-Cause Mortality. JAMA. 2018 Jan 16;319(3):279-290. doi: 10.1001/jama.2017.20513.
- Background Sjostrom L, Peltonen M, Jacobson P, Sjostrom CD, Karason K, Wedel H, Ahlin S, Anveden A, Bengtsson C, Bergmark G, Bouchard C, Carlsson B, Dahlgren S, Karlsson J, Lindroos AK, Lonroth H, Narbro K, Naslund I, Olbers T, Svensson PA, Carlsson LM. Bariatric surgery and long-term cardiovascular events. JAMA. 2012 Jan 4;307(1):56-65. doi: 10.1001/jama.2011.1914.
- Background Colquitt JL, Picot J, Loveman E, Clegg AJ. Surgery for obesity. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003641. doi: 10.1002/14651858.CD003641.pub3.
- Background Karmali S, Brar B, Shi X, Sharma AM, de Gara C, Birch DW. Weight recidivism post-bariatric surgery: a systematic review. Obes Surg. 2013 Nov;23(11):1922-33. doi: 10.1007/s11695-013-1070-4.
- Background Tettero OM, Monpellier VM, Janssen IMC, Steenhuis IHM, van Stralen MM. Early Postoperative Weight Loss Predicts Weight Loss up to 5 Years After Roux-En-Y Gastric Bypass, Banded Roux-En-Y Gastric Bypass, and Sleeve Gastrectomy. Obes Surg. 2022 Sep;32(9):2891-2902. doi: 10.1007/s11695-022-06166-x. Epub 2022 Jul 16.
- Background Mor A, Sharp L, Portenier D, Sudan R, Torquati A. Weight loss at first postoperative visit predicts long-term outcome of Roux-en-Y gastric bypass using Duke weight loss surgery chart. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):556-60. doi: 10.1016/j.soard.2012.06.014. Epub 2012 Jul 16.
- Background Pinto-Bastos A, Conceicao EM, Machado PPP. Reoperative Bariatric Surgery: a Systematic Review of the Reasons for Surgery, Medical and Weight Loss Outcomes, Relevant Behavioral Factors. Obes Surg. 2017 Oct;27(10):2707-2715. doi: 10.1007/s11695-017-2855-7.
- Background RJ Rosenthal. Failure of weight loss or weight regain after bariatric surgery. Bariatric Times. 2012.
- Background McKenna D, Selzer D, Burchett M, Choi J, Mattar SG. Revisional bariatric surgery is more effective for improving obesity-related co-morbidities than it is for reinducing major weight loss. Surg Obes Relat Dis. 2014 Jul-Aug;10(4):654-9. doi: 10.1016/j.soard.2013.12.007. Epub 2013 Dec 18.
- Background Brethauer SA, Kothari S, Sudan R, Williams B, English WJ, Brengman M, Kurian M, Hutter M, Stegemann L, Kallies K, Nguyen NT, Ponce J, Morton JM. Systematic review on reoperative bariatric surgery: American Society for Metabolic and Bariatric Surgery Revision Task Force. Surg Obes Relat Dis. 2014 Sep-Oct;10(5):952-72. doi: 10.1016/j.soard.2014.02.014. Epub 2014 Feb 22.
- Background Christou GA, Katsiki N, Blundell J, Fruhbeck G, Kiortsis DN. Semaglutide as a promising antiobesity drug. Obes Rev. 2019 Jun;20(6):805-815. doi: 10.1111/obr.12839. Epub 2019 Feb 15.
- Background Shaefer CF Jr, Kushner P, Aguilar R. User's guide to mechanism of action and clinical use of GLP-1 receptor agonists. Postgrad Med. 2015;127(8):818-26. doi: 10.1080/00325481.2015.1090295. Epub 2015 Sep 15.
- Background Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O'Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT; STEP 3 Investigators. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama.2021.1831.
- Background Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.
- Background Rubino D, Abrahamsson N, Davies M, Hesse D, Greenway FL, Jensen C, Lingvay I, Mosenzon O, Rosenstock J, Rubio MA, Rudofsky G, Tadayon S, Wadden TA, Dicker D; STEP 4 Investigators. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1414-1425. doi: 10.1001/jama.2021.3224.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Semaglutide | Peptide | 2.4 mg | Subcutaneous |