Glucagon-like peptide-1 (GLP-1) receptor agonist
Semaglutide
Approvedaka Ozempic, Wegovy, Rybelsus
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.
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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.) (opens in a new tab) (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.) (opens in a new tab) (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.) (opens in a new tab) (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
- Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes MellitusPhase 2/Phase 3 · Not Yet Recruiting
- Can Two Dietary Interventions Maintain Weight Loss for 12 Months After GLP-1 Therapy in Adults With Overweight/Obesity?N/A · Not Yet Recruiting
- Regulatory Post Marketing Surveillance (rPMS) Study of Rybelsus (Oral Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in KoreaN/A · Not Yet Recruiting
- GLP-1/GIP Receptor Agonists in Obesity-Related HFpEF: The GLIDE-HF RegistryN/A · Not Yet Recruiting
- SHAPE-ENDO: Pilot Randomized Trial of Multimodal Pre-Surgical Optimization Versus Standard Surgery in Patients With Obesity and Early-Stage Endometrial CancerPhase 4 · Not Yet Recruiting
- Efficacy and Safety of Semaglutide Versus Placebo on Cardiometabolic Profile in Patients With Schizophrenia With Metabolic SyndromePhase 3 · Not Yet Recruiting
- Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 DiabetesPhase 3 · Not Yet Recruiting
Related News & Research
- Danish Registry Study Estimates Heart-Attack Risk in Patients Who Would Qualify for SELECT
- This Week in Peptide Research: CagriSema's Cardiovascular Trial Baseline, a Retatrutide Safety Case, and Male Osteoporosis Guidance
- Chinese Phase 3 Trial Finds 'Chemically Synthesized' Semaglutide Copy Equivalent to Wegovy for Weight Loss
- Nature Medicine Publishes REMODEL Trial: Semaglutide Missed Its Primary Kidney Imaging Endpoints, But Biopsy Data Point to Reduced Fibrosis
- PNAS Study Finds Experimental RNA Therapy Preserved Lean Mass When Combined With Semaglutide in Mice
Latest research
- The pharmacotherapy for pediatric obesity: insights and challenges from adult weight-loss medications. (opens in a new tab)
Journal of diabetes and metabolic disorders · Oct 12, 2026
- Cardiovascular outcomes with tirzepatide versus semaglutide in type 2 diabetes. (opens in a new tab)
Journal of diabetes and metabolic disorders · Oct 5, 2026
- Weight gain, adipose tissue remodeling and cardiometabolic disease in people with HIV. (opens in a new tab)
Current opinion in HIV and AIDS · Oct 1, 2026
Common Questions
- What is Semaglutide?
- Semaglutide is a GLP-1 receptor agonist from Novo Nordisk, marketed as Ozempic and Rybelsus (type 2 diabetes) and Wegovy (chronic weight management and cardiovascular risk reduction). It is FDA- and EMA-approved and TGA-registered, supported by the SUSTAIN, STEP, and SELECT trial programs.
- Is Semaglutide approved for medical use?
- Semaglutide is approved for one or more medical uses in at least one major jurisdiction. 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. European Union (EMA): Authorized - Ozempic and Rybelsus for type 2 diabetes and Wegovy for weight management. Australia (TGA): Registered on the ARTG - Ozempic for type 2 diabetes and Wegovy for weight management, available on prescription.
- How does Semaglutide work?
- 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.
- Is Semaglutide legal in Australia?
- Semaglutide in Australia (TGA): Registered on the ARTG - Ozempic for type 2 diabetes and Wegovy for weight management, available on prescription.
- Is Semaglutide banned in sport?
- Semaglutide under the World Anti-Doping Agency (WADA) code: Not prohibited. On the WADA Monitoring Program (introduced 2024, continued into 2026); it is tracked but not a banned substance.