Library / Weight and metabolic
Semaglutide
Also known as Ozempic, Wegovy, Rybelsus
Approved medicine
GLP-1 receptor agonist peptide that acts on appetite and insulin release. Approved for type 2 diabetes and for chronic weight management in adults with obesity or overweight with a related condition.
Prescription medicine. Only a prescriber can decide whether a medicine suits you and at what dose. This page is information, not a recommendation.
Background
Developed by Novo Nordisk as a longer acting version of liraglutide, itself based on the human gut hormone GLP-1. Changes to the molecule, including a fatty acid side chain that binds albumin, let it last about a week. First FDA approval was Ozempic for type 2 diabetes in 2017.
How it is thought to work
Mimics GLP-1, a hormone released after eating. It increases insulin release when blood sugar is high, lowers glucagon, slows stomach emptying and acts on the brain to reduce appetite.
What is claimed, and the evidence
| Claim | Evidence | Notes |
|---|---|---|
| Improves blood sugar control in adults with type 2 diabetes | Approved use | Ozempic and Rybelsus labels. |
| Chronic weight management in adults with obesity, or overweight with a weight related condition, and in adolescents aged 12 and over | Approved use | Wegovy label. STEP 1 trial: mean weight change of about minus 15% with 2.4 mg weekly versus minus 2.4% with placebo over 68 weeks. |
| Reduces risk of heart attack, stroke and cardiovascular death | Approved use | In type 2 diabetes with heart disease (Ozempic) and in obesity with established heart disease (Wegovy; SELECT trial, 20% relative risk reduction). |
| Slows kidney decline in type 2 diabetes with chronic kidney disease | Approved use | Ozempic label. |
| Treats MASH (fatty liver inflammation) with moderate to advanced fibrosis | Approved use | Wegovy label, US accelerated approval pending confirmatory data. |
| Reduces alcohol or other addictive cravings | No published evidence | Widely reported by users; early studies are ongoing and it is not approved for this. |
| Compounded or 'research' semaglutide works the same as the approved medicine | No published evidence | FDA warns salt forms and research labelled products are different or of unknown quality. Pharmacy compounding of GLP-1 medicines has been banned in Australia since 1 October 2024. |
Side effects
| Effect | How often | Notes |
|---|---|---|
| Nausea | Common | Most common side effect on the label; usually during dose increases. |
| Diarrhoea, vomiting, constipation and abdominal pain | Common | Label lists these at 5% or more. |
| Headache, fatigue, dizziness, indigestion, burping, wind and bloating | Common | Listed at 5% or more in the Wegovy label. |
| Hair loss | Common | Listed in the Wegovy label, linked with rapid weight loss. |
| Gallbladder disease (gallstones, inflammation) Serious | Uncommon | Label warning; more frequent than placebo in trials. |
| Acute pancreatitis Serious | Rare | Label warning; stop if suspected. |
| Low blood sugar when used with insulin or sulfonylureas Serious | Common | Label warning; risk mainly with other diabetes medicines. |
| Acute kidney injury from dehydration Serious | Rare | Label warning, usually after severe vomiting or diarrhoea. |
| Worsening diabetic eye disease Serious | Uncommon | Label warning in people with existing diabetic retinopathy. |
| Serious allergic reactions including anaphylaxis and angioedema Serious | Rare | Label warning. |
| Increased heart rate | Common | Label warning for Wegovy. |
| Aspiration of stomach contents during anaesthesia or sedation Serious | Rare | Label warning because the stomach empties more slowly. |
Warnings
- Boxed warning: causes thyroid C-cell tumours in rodents; human relevance unknown. Not for people with a personal or family history of medullary thyroid cancer or MEN 2.
- Can cause pancreatitis, gallbladder disease and kidney injury from dehydration.
- Tell the surgical or procedure team before any anaesthesia or deep sedation because of aspiration risk.
- FDA has received reports of hospitalisations linked to dosing errors with compounded semaglutide and warns against salt forms and products sold 'for research purposes'.
- Pharmacy compounded GLP-1 products have not been permitted in Australia since 1 October 2024; counterfeit Ozempic has been reported.
Phase 3 trials
STEP UP
Phase 3b, Completed, published. 1,407 participants, 72 weeks, stepping up every 4 weeks. NCT05646706
- Population
- Adults with BMI of 30 or more without diabetes.
- Arms
- Semaglutide 7.2 mg weekly; Semaglutide 2.4 mg weekly; Placebo
- Primary outcome
- Percentage change in body weight, 7.2 mg against placebo.
- Results
- Body weight changed by minus 18.7% on 7.2 mg and minus 15.6% on 2.4 mg against minus 3.9% on placebo.
- Safety
- Gastrointestinal effects 70.8%, 61.2% and 42.8%. Dysaesthesia 22.9%, 6.0% and 0.5%. Serious adverse events 6.8%, 10.9% and 5.5%.
- Source
- Wharton S et al. Lancet Diabetes Endocrinol 2025;13:949-63.
Doses in these trials were given under medical supervision.
Regulatory status
- Australia
- Approved (ARTG, e.g. Ozempic, Wegovy). Schedule 4. Pharmacy compounding of GLP-1 receptor agonists has been prohibited since 1 October 2024.
- United States
- FDA approved (Ozempic 2017 for type 2 diabetes; Wegovy for chronic weight management; Rybelsus oral). Removed from the FDA drug shortage list in February 2025, ending shortage based compounding.
Sources
- DailyMed: Wegovy (semaglutide) prescribing information
- DailyMed: Ozempic (semaglutide) prescribing information
- Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1)
- Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT)
- FDA: FDA's concerns with unapproved GLP-1 drugs used for weight loss
- TGA ARTG search: semaglutide
- Drugs@FDA: Ozempic (semaglutide)
- TGA: Update on GLP-1 receptor agonist pharmacy compounding changes
Also in Weight and metabolic
From the VialOwl library, reviewed 26 September 2026. For education and general information. It is not medical advice and not a recommendation to use Semaglutide.