What it is
Semaglutide is a GLP-1 receptor agonist, an analogue of the gut hormone glucagon-like peptide-1 modified with a fatty-acid side chain that extends its half-life to about one week. It is an approved medicine, marketed by Novo Nordisk as Ozempic (weekly injection) and Rybelsus (daily tablet) for type 2 diabetes and as Wegovy (weekly injection) for chronic weight management. It is one of the most extensively trialled compounds in obesity, diabetes, and cardiovascular research.
How it works
It activates the GLP-1 receptor, a pathway studied for glucose-dependent insulin secretion, reduced glucagon release, slower gastric emptying, and appetite signalling in the brain. Binding to albumin slows its clearance, which supports the once-weekly schedule used in most of its trials.
Regulatory status
- Cosmetic ingredient
- Research compound
- In clinical trials
- Approved medicine
Approved as a medicine by the FDA or the EMA for at least one indication. Approval covers the named indication and formulation only.
What published research is studying
- Weight reduction in adults with overweight or obesity, with and without type 2 diabetes (Phase 3)
- Major adverse cardiovascular events in type 2 diabetes and in obesity without diabetes (outcome trials)
- Kidney disease progression in type 2 diabetes with chronic kidney disease (outcome trial)
- Heart failure with preserved ejection fraction and knee osteoarthritis in people with obesity
Key findings
In the 68-week Phase 3 STEP 1 trial in 1,961 adults with overweight or obesity without diabetes, mean body weight fell 14.9% in the 2.4 mg group, against 2.4% with placebo.
Wilding JPH et al., N Engl J Med 2021In the 68-week Phase 3 STEP 2 trial in 1,210 adults with overweight or obesity and type 2 diabetes, mean body weight fell 9.6% in the 2.4 mg group, against 3.4% with placebo.
Davies M et al., Lancet 2021In the 104-week SUSTAIN-6 trial in 3,297 adults with type 2 diabetes at high cardiovascular risk, cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke occurred in 6.6% of the semaglutide group and 8.9% of the placebo group (hazard ratio 0.74), while retinopathy complications were more frequent with semaglutide.
Marso SP et al., N Engl J Med 2016In the SELECT trial in 17,604 adults with established cardiovascular disease and overweight or obesity but no diabetes, followed for a mean of 39.8 months, cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke occurred in 6.5% of the 2.4 mg group and 8.0% of the placebo group (hazard ratio 0.80).
Lincoff AM et al., N Engl J Med 2023In the FLOW trial in 3,533 adults with type 2 diabetes and chronic kidney disease, stopped early after a prespecified interim analysis at a median follow-up of 3.4 years, the risk of major kidney disease events was 24% lower in the 1.0 mg group than with placebo (hazard ratio 0.76).
Perkovic V et al., N Engl J Med 2024
What the studies measured
Study durations
- Phase 3 obesity trial: 68 weeks of once-weekly dosing plus lifestyle intervention (NCT03548935).
- Phase 3 trial in obesity with type 2 diabetes: 68 weeks (NCT03552757).
- Cardiovascular outcomes trial in type 2 diabetes: 104 weeks (NCT01720446).
- Cardiovascular outcomes trial in obesity without diabetes: mean follow-up of 39.8 months (NCT03574597).
- Kidney outcomes trial in type 2 diabetes with chronic kidney disease: median follow-up of 3.4 years (NCT03819153).
Endpoints
- Percent change in body weight from baseline
- Proportion reaching 5%, 10%, or 15% weight reduction
- Major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke)
- Major kidney disease events and annual eGFR slope
- Gastrointestinal adverse events, retinopathy complications, and discontinuation
How strong is the evidence?
Human evidence is extensive, with several large randomised Phase 3 trials, including cardiovascular and kidney outcome trials that followed participants for two to more than three years.
Common questions
Is Semaglutide an approved medicine?
Approved medicine. Approved as a medicine by the FDA or the EMA for at least one indication. Approval covers the named indication and formulation only.
How much human research is there on Semaglutide?
Human evidence is extensive, with several large randomised Phase 3 trials, including cardiovascular and kidney outcome trials that followed participants for two to more than three years.
Does UU supply Semaglutide?
Yes, as premium-grade research material for laboratory use. Every batch is tested by an independent lab and the certificate of analysis is published.