What Is Wegovy Approved For? Label Indications, Per the Research

Wegovy is a prescription medicine. Its active ingredient is semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist delivered as a once-weekly subcutaneous injection, and a review of GLP-1 receptor agonist pharmacology described this drug class as acting on GLP-1 receptors to influence glucose-dependent insulin secretion, gastric emptying and appetite signalling (https://pubmed.ncbi.nlm.nih.gov/33068776/). The phase 3 STEP 2 trial evaluated once-weekly subcutaneous semaglutide 2·4 mg against placebo in adults with overweight or obesity and type 2 diabetes, which is the strength that regulators reviewed for weight-management labelling (https://pubmed.ncbi.nlm.nih.gov/33667417/). This page summarises what the product is licensed for according to regulators, and separates that from uses that have only been studied in trials.

This page is for educational purposes only and is not medical advice; consult a licensed physician or prescribing clinician about whether any medicine is appropriate, and rely on the current approved labelling in the relevant country for authoritative wording.

Approved Indications at a Glance

The table below lists the indications regulators have granted for Wegovy, with the year each was authorised. Label wording differs between agencies and is periodically revised, so the official prescribing information held by each regulator is the controlling document.

Chronic Weight Management in Adults

The original 2021 US approval covered chronic weight management in adults whose body mass index met the obesity threshold, or the overweight threshold together with at least one weight-related condition such as hypertension, type 2 diabetes or dyslipidaemia. The label frames the medicine as an adjunct to a reduced-calorie diet and increased physical activity rather than a standalone intervention.

The evidence package behind that indication came from the STEP programme. In STEP 2, researchers randomised adults with overweight or obesity and type 2 diabetes to once-weekly semaglutide 2·4 mg, 1·0 mg or placebo and reported greater reductions in body weight with the 2·4 mg group than with placebo over 68 weeks (https://pubmed.ncbi.nlm.nih.gov/33667417/). A narrative review of semaglutide for obesity summarised the programme and described weekly semaglutide 2·4 mg as producing substantially greater weight reduction than placebo across the trials reviewed (https://pubmed.ncbi.nlm.nih.gov/34942372/).

Comparative data also exist. The STEP 8 randomised clinical trial compared once-weekly semaglutide 2·4 mg with daily liraglutide 3·0 mg in adults with overweight or obesity without diabetes, and the study reported greater mean weight loss at week 68 in the semaglutide group (https://pubmed.ncbi.nlm.nih.gov/35015037/). In STEP 10, researchers studied once-weekly semaglutide 2·4 mg versus placebo specifically in people with obesity and prediabetes and reported both weight reduction and a higher proportion of participants reverting to normoglycaemia with semaglutide (https://pubmed.ncbi.nlm.nih.gov/39089293/). Prediabetes itself is not a separate licensed indication; it was one of the populations studied within the weight-management evidence base.

Adolescents aged 12 and older

In 2022 the US label was extended to adolescents aged 12 years and older with obesity defined by body mass index at or above the 95th percentile for age and sex. European labelling was subsequently expanded to an adolescent population as well. As with the adult indication, the licensed context is weight management alongside diet and physical activity, and eligibility is determined by a prescribing clinician against the criteria in the approved label.

Cardiovascular Risk Reduction

In 2024 the US Food and Drug Administration added an indication for reducing the risk of major adverse cardiovascular events — described in the label as cardiovascular death, non-fatal myocardial infarction and non-fatal stroke — in adults with established cardiovascular disease and either obesity or overweight. This made Wegovy the first medicine of its type to carry a cardiovascular outcomes indication in that population. European labelling was subsequently updated along similar lines.

This is a regulatory fact rather than a claim about any individual's expected outcome. The size of any benefit, the populations in which it was observed and the limits of the data are set out in the cardiovascular outcomes trial documentation referenced by the regulator, and those details are matters for a prescribing clinician to interpret.

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

In 2025 the FDA granted accelerated approval for use in adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis accompanied by moderate to advanced liver fibrosis, in addition to diet and exercise. Accelerated approval is a pathway in which authorisation rests on a surrogate endpoint considered reasonably likely to predict clinical benefit, with confirmatory evidence required to maintain the indication.

The supporting evidence was published as a phase 3 trial of semaglutide in metabolic dysfunction-associated steatohepatitis, in which researchers reported that once-weekly semaglutide 2·4 mg produced higher rates of steatohepatitis resolution without worsening of fibrosis, and of fibrosis improvement without worsening of steatohepatitis, than placebo (https://pubmed.ncbi.nlm.nih.gov/40305708/). Cirrhotic MASH was outside the approved population described in that labelling.

Uses That Have Been Studied But Are Not Approved Indications

Several semaglutide applications appear in the published literature without forming part of the Wegovy label. These are investigational or pertain to different products, and none of them should be read as approved uses.

• Higher-dose weekly semaglutide. The STEP UP phase 3b trial examined once-weekly semaglutide 7·2 mg in adults with obesity and researchers reported greater mean weight reduction than placebo, with a gastrointestinal adverse-event profile consistent with the drug class (https://pubmed.ncbi.nlm.nih.gov/40961952/). That strength is a trial intervention, not part of the approved weight-management labelling described above.
• Oral semaglutide for weight management. OASIS 1 was a phase 3 trial of oral semaglutide 50 mg once daily in adults with overweight or obesity, and the study reported significantly greater weight reduction than placebo at week 68 (https://pubmed.ncbi.nlm.nih.gov/37385278/). Oral formulations are regulated as separate products with their own labelling; Wegovy is an injection.
• Combination with cagrilintide. A phase 2 trial co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in people with type 2 diabetes and researchers reported changes in glycaemic and body-weight endpoints versus active comparators (https://pubmed.ncbi.nlm.nih.gov/37364590/). That combination is a separate investigational product.
• Glycaemic control in type 2 diabetes. Semaglutide is licensed for type 2 diabetes under different brand names and strengths; for example, a head-to-head trial compared tirzepatide with once-weekly semaglutide 1 mg in patients with type 2 diabetes and reported greater HbA1c reduction with tirzepatide at the doses tested (https://pubmed.ncbi.nlm.nih.gov/34170647/). Diabetes glycaemic control is not an indication carried by Wegovy itself.

Prescribing a medicine outside its licensed indication is a clinical decision governed by local regulation and professional judgement, and it falls entirely to a prescribing clinician.

Adverse Events: What Studies Report

A dedicated safety review of semaglutide reported that gastrointestinal events — most commonly nausea, vomiting, diarrhoea and constipation — were the adverse events seen most often across the clinical programme, that they were typically mild to moderate and transient, and that they were the leading reason for treatment discontinuation (https://pubmed.ncbi.nlm.nih.gov/34305810/). In STEP 2, researchers reported that gastrointestinal disorders were more frequent with semaglutide 2·4 mg than with placebo in adults with overweight or obesity and type 2 diabetes (https://pubmed.ncbi.nlm.nih.gov/33667417/). STEP 10 similarly reported gastrointestinal adverse events as the most common with semaglutide 2·4 mg in people with obesity and prediabetes (https://pubmed.ncbi.nlm.nih.gov/39089293/), and the STEP UP trial reported gastrointestinal events as the predominant category at the higher 7·2 mg strength tested (https://pubmed.ncbi.nlm.nih.gov/40961952/).

A review of sex-related differences in GLP-1 biology noted that responses to GLP-1 and its analogues have been reported to differ between males and females across preclinical and clinical settings, an area the authors described as under-examined (https://pubmed.ncbi.nlm.nih.gov/39715341/). Contraindications, warnings and monitoring requirements are listed in the approved label and are a matter for the prescribing clinician.

Why Brand Name and Indication Are Not Interchangeable

Semaglutide is marketed under several brand names with distinct strengths, formulations and licensed indications. A finding generated with one product does not automatically transfer to another, because regulators approve a specific formulation at specific strengths for specific populations. A review of semaglutide in obesity described how the weight-management programme used a different dosing strategy from the diabetes programme (https://pubmed.ncbi.nlm.nih.gov/34942372/), and the broader GLP-1 receptor agonist literature described meaningful differences in pharmacokinetics and indications across agents in the class (https://pubmed.ncbi.nlm.nih.gov/33068776/).

Questions a Reader Might Bring to a Clinician

1. Which approved indication, if any, applies to a given individual's circumstances under the current label in their country?
2. What does the label say about contraindications, warnings and the conditions under which treatment is reviewed or stopped?
3. How do the populations enrolled in the published trials compare with the individual's own medical history?
4. What monitoring does the approved labelling describe, and who is responsible for it?
5. For the accelerated-approval MASH indication, what confirmatory evidence is still outstanding?

Approval status changes as regulators review new submissions. The most reliable sources are the current prescribing information published by the FDA, the EMA, the MHRA or the relevant national agency, together with the peer-reviewed trial reports listed below.

References

• 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, 2021)
• Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial (JAMA, 2022)
• Efficacy and safety of once-weekly semaglutide 2·4 mg versus placebo in people with obesity and prediabetes (STEP 10): a randomised, double-blind, placebo-controlled, multicentre phase 3 trial (The Lancet Diabetes & Endocrinology, 2024)
• Once-weekly semaglutide 7·2 mg in adults with obesity (STEP UP): a randomised, controlled, phase 3b trial (The Lancet Diabetes & Endocrinology, 2025)
• Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis (New England Journal of Medicine, 2025)
• Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial (Lancet, 2023)
• Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial (Lancet, 2023)
• Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes (New England Journal of Medicine, 2021)
• Safety of Semaglutide (Frontiers in Endocrinology, 2021)
• Semaglutide for the treatment of obesity (Trends in Cardiovascular Medicine, 2023)
• GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art (Molecular Metabolism, 2021)
• GLP-1 and Its Analogs: Does Sex Matter? (Endocrinology, 2025)