PEP-0070FDA-approved

SEMAGLUTIDE

Also known as Ozempic

Long-acting GLP-1 receptor agonist with extensive Phase III and post-marketing data for type-2 diabetes and obesity.


Evidence

Strong· 9.8

Strong human RCT or meta-analysis

Risk band

Low

Well-characterized, minor reported AEs

Summary

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that is FDA-approved for type 2 diabetes and for chronic weight management [1,2]. It has demonstrated the largest weight loss of any obesity medication to date, with reductions of approximately 15% of initial body weight at 68 weeks accompanied by improvements in cardiovascular risk factors [2]. Phase 3 randomized trial data (STEP 2) showed that 68.8% of adults with overweight or obesity and type 2 diabetes achieved at least 5% weight loss on semaglutide 2.4 mg versus 28.5% on placebo, and a systematic review and meta-analysis confirmed an 11.85% weight reduction versus placebo in obesity without diabetes [3,4]. The main caveat is a higher rate of mostly mild-to-moderate gastrointestinal adverse events, along with increased treatment discontinuation and serious adverse events relative to placebo, though the overall risk/benefit profile is favorable [1,3,4]. This is a robust, multi-trial, regulatory-approved evidence base.

Sources

  1. 1. Safety of Semaglutide Frontiers in endocrinology, 2021.
  2. 2. Semaglutide for the treatment of obesity Trends in cardiovascular medicine, 2023.
  3. 3. Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial Lancet (London, England), 2021.
  4. 4. Efficacy and Safety of Semaglutide for Weight Loss in Obesity Without Diabetes: A Systematic Review and Meta-Analysis Journal of the ASEAN Federation of Endocrine Societies, 2022.

For educational purposes only.