Semaglutide
Semaglutide is an approved once-weekly injectable (and once-daily oral) GLP-1 therapy for type 2 diabetes and, at higher doses, for chronic weight management. Randomized trials demonstrate meaningful reductions in HbA1c and body weight, and the SELECT trial showed reduced cardiovascular events in people with overweight or obesity and established cardiovascular disease. It is a prescription medicine used under medical supervision.
Mechanism
In plain terms, semaglutide copies a natural gut hormone that signals fullness and helps control blood sugar. Technically, it is a GLP-1 analogue with high homology to human GLP-1 that agonizes the GLP-1 receptor, stimulating glucose-dependent insulin secretion, suppressing glucagon release, slowing gastric emptying, and acting on appetite-regulating centers to reduce energy intake. Structural modifications extend its half-life to allow once-weekly (injectable) dosing.
Regulatory Status by Region
- United States (FDA)Approved. Ozempic for type 2 diabetes (2017, cardiovascular risk reduction added 2020); Rybelsus oral for type 2 diabetes (2019); Wegovy for chronic weight management (2021) and cardiovascular risk reduction (2024); oral Wegovy for weight management approved in 2025.
- Australia (TGA)Registered on the ARTG - Ozempic for type 2 diabetes and Wegovy for weight management, available on prescription.
- European Union (EMA)Authorized - Ozempic and Rybelsus for type 2 diabetes and Wegovy for weight management.
- WADANot prohibited. On the WADA Monitoring Program (introduced 2024, continued into 2026); it is tracked but not a banned substance.
Key Studies
- Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1; Wilding et al.) (N Engl J Med 2021;384:989-1002; DOI 10.1056/NEJMoa2032183; PMID 33567185)
- Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT; Lincoff et al.) (N Engl J Med 2023;389:2221-2232; DOI 10.1056/NEJMoa2307563; PMID 37952131)
- Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes (SUSTAIN-6; Marso et al.) (N Engl J Med 2016;375:1834-1844; DOI 10.1056/NEJMoa1607141; PMID 27633186)
Related Clinical Trials
- Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN)N/A · Not Yet Recruiting
- SHIELD-T1D: Shingrix and GLP-1 Agonist for Beta-Cell Preservation in Recent-Onset Type 1 Diabetes.Phase 2 · Not Yet Recruiting
- Glucagon-Like Peptide-1 Receptor Agonists to Attenuate Metabolic Risk in Individuals With Duchenne Muscular DystrophyPhase 1/Phase 2 · Not Yet Recruiting
- BALANCE-OBS: Bofanglutide (GZR18) Versus Semaglutide in Latin American Adults With Overweight or ObesityPhase 3 · Not Yet Recruiting
- GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute PancreatitisPhase 4 · Not Yet Recruiting
- Semaglutide for Treatment of People With Methamphetamine Use Disorder: the SHIFT StudyPhase 2 · Not Yet Recruiting
- A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 DiabetesPhase 2 · Not Yet Recruiting
- A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 DiabetesPhase 3 · Not Yet Recruiting