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

The short answer

Victoza is a prescription medicine whose active ingredient is liraglutide, a once-daily injectable glucagon-like peptide-1 (GLP-1) receptor agonist. Its approved label indications centre on type 2 diabetes: improving glycaemic control as an adjunct to diet and exercise, and — in a later label expansion — reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes who also have established cardiovascular disease. Everything else that appears in the liraglutide literature, including chronic weight management, falls either under a different liraglutide-containing product with its own separate approval or under off-label and investigational use.

This page summarises what the regulatory record and the published trial literature describe. It does not cover dosing, product selection or treatment decisions, all of which are matters for a prescribing clinician.

What liraglutide is, as described in the literature

Liraglutide is an acylated analogue of human GLP-1. Researchers who reviewed the discovery programme behind liraglutide and semaglutide described how attaching a fatty-acid side chain to the peptide backbone promoted reversible binding to serum albumin, which slowed clearance and supported once-daily administration for liraglutide, with the later semaglutide molecule extending that principle to weekly dosing (PMID 31031702). A separate medicinal-chemistry paper on the semaglutide discovery programme described the same albumin-binding strategy being optimised further for protraction (PMID 26308095).

A state-of-the-art review of GLP-1 receptor agonists in type 2 diabetes reported that drugs in this class lowered glycated haemoglobin and body weight with a low intrinsic risk of hypoglycaemia, and that cardiovascular outcome trials in the class showed benefit in populations at high cardiovascular risk (PMID 33068776). That pharmacological profile is the background against which the Victoza label indications were granted.

Approved indications at a glance

Approval timeline

• June 2009 — European Union. The European Commission granted marketing authorisation for Victoza for the treatment of type 2 diabetes mellitus in adults.
• January 2010 — United States. The US Food and Drug Administration approved Victoza as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.
• 2017 — cardiovascular label expansion. Regulators added an indication for reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, following the drug's dedicated cardiovascular outcomes programme.
• 2019 — paediatric extension. The indication for glycaemic control in type 2 diabetes was extended to paediatric patients aged 10 years and older.

Exact wording, age cut-offs and contraindications differ between the US prescribing information and the EU summary of product characteristics, and both documents are revised over time. The authoritative text for any given country is the current label approved by that country's regulator.

Why the type 2 diabetes indication was granted

The glycaemic indication rests on a phase 3 programme in type 2 diabetes in which liraglutide was studied as monotherapy and alongside other glucose-lowering agents. Reviewers summarising the class reported that GLP-1 receptor agonists reduced glycated haemoglobin through glucose-dependent insulin secretion, suppression of glucagon and slowed gastric emptying, and that the glucose-dependence of the insulin response explained the low rate of hypoglycaemia when the drugs were used without insulin or sulfonylureas (PMID 33068776). The same review reported weight reduction as a consistent secondary finding across the class in people with type 2 diabetes (PMID 33068776).

The cardiovascular indication

The cardiovascular indication is narrower than the glycaemic one: it applies to adults who have both type 2 diabetes and established cardiovascular disease, and it is tied to the reduction of major adverse cardiovascular events rather than to any general claim about heart health. The class review noted that cardiovascular outcome trials of GLP-1 receptor agonists demonstrated benefit in high-risk populations, which is the evidentiary category this indication sits in (PMID 33068776).

Weight management: a different product, not the Victoza label

Liraglutide is also marketed at a higher strength under a different brand name for chronic weight management, with its own regulatory approval, its own clinical programme and its own label population. That distinction matters because much of the liraglutide weight-loss literature is often read as if it applied to Victoza, when in fact it supports the separate obesity product.

In the STEP 8 randomised clinical trial, researchers compared once-weekly semaglutide 2.4 mg with once-daily liraglutide 3.0 mg in adults with overweight or obesity without diabetes over 68 weeks, and reported a mean body-weight change of −15.8% with semaglutide versus −6.4% with liraglutide (PMID 35015037). Narrative reviews of weight-loss pharmacotherapy placed liraglutide among the approved anti-obesity agents alongside newer incretin-based drugs and described the field's rapid expansion (PMID 39277293), and a primary-care review of obesity pharmacotherapy similarly catalogued GLP-1-based options within a broader management framework (PMID 42101582). A 2016 Lancet review of obesity management set pharmacotherapy within lifestyle, behavioural and surgical approaches (PMID 26868660). None of this literature changes the Victoza label, which does not carry a weight-management indication.

Off-label and investigational uses described in the literature

The following areas appear in published research. They are not approved Victoza indications, and listing them is descriptive, not an endorsement of use.

Obesity in younger children

A randomised trial published in The New England Journal of Medicine studied liraglutide in children aged 6 to under 12 years with obesity and reported a greater reduction in BMI with liraglutide than with placebo, alongside more frequent gastrointestinal adverse events in the liraglutide group (PMID 39258838). That age group sits outside the Victoza label entirely, and the trial addressed obesity rather than glycaemic control.

Obesity in adolescents and older adults

A 2025 review examined GLP-1 receptor agonists and GIP/GLP-1 co-agonists for obesity specifically in adolescents and in elderly populations, summarising efficacy and tolerability considerations that differ by age group (PMID 40716192).

Inflammation and immune signalling

A pharmacological review summarised anti-inflammatory and immunological properties attributed to GLP-1 receptor agonists across preclinical and early clinical work (PMID 35738455). This remains mechanistic and investigational territory with no corresponding approved indication.

Central nervous system mechanisms

A mechanistic study in Cell Metabolism reported that tanycytes controlled hypothalamic uptake of liraglutide and that this transport step influenced the drug's anti-obesity actions in the animal models studied (PMID 35716660). Findings of this kind describe how the molecule reaches its central targets; they are not clinical indications.

Tolerability and Adverse Events: What Studies Report

A review of GLP-1 agonists written for emergency clinicians reported that gastrointestinal effects — nausea, vomiting, diarrhoea and constipation — were the most commonly described adverse events in the class, and discussed delayed gastric emptying with implications for procedural sedation, as well as reports of pancreatitis and of hypoglycaemia when these agents were combined with insulin or sulfonylureas (PMID 38241775). The state-of-the-art diabetes review likewise reported gastrointestinal intolerance as the principal limitation of the class in routine use (PMID 33068776). In the paediatric obesity trial, the study reported gastrointestinal adverse events more often among children assigned to liraglutide than among those assigned to placebo (PMID 39258838). Labelled warnings, contraindications and monitoring requirements — including those relating to thyroid C-cell tumours observed in rodents — are set out in the approved prescribing information and are assessed individually by a prescribing clinician.

How to read an indication statement

1. Indications are population-specific. The cardiovascular indication applies only to adults with type 2 diabetes and established cardiovascular disease, not to everyone taking the drug.
2. Brand names matter. Two products can share the same active molecule and still have entirely different approved indications and strengths.
3. Jurisdictions differ. A use approved in one region may not be approved in another, and labels are revised as new data arrive.
4. Published trials are not labels. A positive trial result does not make a use approved; approval follows regulatory review of a submitted dossier.

Questions a prescribing clinician is positioned to answer

• Whether an approved indication applies to a particular person's diagnosis and history.
• How the drug interacts with other glucose-lowering medicines, including insulin and sulfonylureas, which the emergency-medicine review linked to hypoglycaemia risk in this class (PMID 38241775).
• What monitoring, contraindications and warnings the current approved label specifies.
• How the Victoza label differs from that of other liraglutide-containing or GLP-1-based products.

This page is for educational purposes only and is not medical advice; consult a licensed physician or other qualified prescriber about any medicine, indication or treatment decision.

References

• The Discovery and Development of Liraglutide and Semaglutide (Frontiers in Endocrinology, 2019)
• Discovery of the Once-Weekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide (Journal of Medicinal Chemistry, 2015)
• GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art (Molecular Metabolism, 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)
• Liraglutide for Children 6 to <12 Years of Age with Obesity - A Randomized Trial (New England Journal of Medicine, 2025)
• Weight Loss Pharmacotherapy: Current and Future Therapies (Gastrointestinal Endoscopy Clinics of North America, 2024)
• Obesity Management: Pharmacotherapy (FP Essentials, 2026)
• Management of obesity (Lancet, 2016)
• GLP-1 receptor agonists and GIP/GLP-1 co-agonists in the treatment of obesity in adolescents and the elderly (Medicina Clinica, 2025)
• The anti-inflammatory and immunological properties of GLP-1 Receptor Agonists (Pharmacological Research, 2022)
• Tanycytes control hypothalamic liraglutide uptake and its anti-obesity actions (Cell Metabolism, 2022)
• GLP-1 agonists: A review for emergency clinicians (American Journal of Emergency Medicine, 2024)