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

Ozempic is a prescription medicine. It contains semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist administered as a once-weekly subcutaneous injection, and it is approved by regulators including the US Food and Drug Administration and the European Medicines Agency. Its approved indications sit entirely within adult type 2 diabetes care: glycaemic control, cardiovascular risk reduction in defined populations, and — in more recent US labelling — kidney outcomes in people who also have chronic kidney disease. Everything else that semaglutide has been studied for belongs either to a different branded semaglutide product with its own separate approval, or to the investigational column.

This page describes what regulators approved and what the published pivotal literature reported. It does not describe dosing, scheduling or suitability. Those are decisions for a prescribing clinician who knows an individual's history.

The approved indications on the Ozempic label

Approved indications are written by regulators, not by journals, and they differ between countries and change over time. The table below summarises the indications that have been added to the Ozempic label in the two largest regulatory regions. Readers checking current status should consult the official product information for their own jurisdiction, because labels are revised.

Three features of that list matter for anyone reading about semaglutide online. First, every approved Ozempic indication requires a diagnosis of type 2 diabetes. Second, the cardiovascular and kidney indications are additional to the glycaemic one and apply to narrower populations defined by existing disease. Third, chronic weight management does not appear on the Ozempic label at all — that indication belongs to a separate semaglutide product, as described below.

Where the molecule came from

Semaglutide was developed from the same programme that produced liraglutide, and researchers have described the medicinal-chemistry steps — fatty-acid acylation and amino-acid substitution to resist enzymatic degradation and extend half-life — that made once-weekly administration feasible (PMID 31031702). A state-of-the-art review of GLP-1 receptor agonists in type 2 diabetes summarised how this drug class lowers blood glucose through glucose-dependent insulin secretion, suppression of glucagon release and slowed gastric emptying, and reported that agents in the class also reduce body weight as a consequence of reduced energy intake (PMID 33068776). That mechanistic overlap is why the same molecule appears in diabetes, obesity and metabolic-liver trials — but shared mechanism is not shared approval.

Trial evidence sitting behind the diabetes indication

The glycaemic indication rests on the SUSTAIN programme, which is summarised in the regulatory documentation rather than in the papers verified for this page. Among the peer-reviewed trials available here, the head-to-head SURPASS-2 study is the most directly relevant: researchers randomised adults with type 2 diabetes to tirzepatide at 5 mg, 10 mg or 15 mg once weekly or to semaglutide 1 mg once weekly for 40 weeks, and the study reported greater mean reductions in glycated haemoglobin and body weight with all three tirzepatide doses than with semaglutide 1 mg (PMID 34170647). That trial is useful context for how semaglutide performs as an active comparator in diabetes; it does not change what either product is approved for.

A narrative review of semaglutide in obesity described the broader development arc, noting that the compound was first brought forward for type 2 diabetes before higher-dose formulations were investigated for weight management (PMID 34942372).

Same molecule, different products, different approvals

Semaglutide is marketed under more than one brand name, and each brand carries its own approved indications. Chronic weight management in adults with obesity or overweight with weight-related comorbidities was approved in 2021 for the higher-dose weekly semaglutide injection sold under a different brand, and an oral semaglutide tablet was approved in 2019 for type 2 diabetes under a third brand. These are separate marketing authorisations with separate labels. A trial of 2.4 mg weekly semaglutide is therefore evidence for that product's label, not for Ozempic's.

The pivotal weight-management literature is extensive. In STEP 2, researchers randomised adults with overweight or obesity and type 2 diabetes to semaglutide 2.4 mg weekly, semaglutide 1.0 mg weekly or placebo for 68 weeks, and the study reported significantly greater mean body-weight reduction with 2.4 mg than with placebo (PMID 33667417). In STEP 8, a randomised trial in adults with overweight or obesity without diabetes, researchers compared semaglutide 2.4 mg once weekly with liraglutide 3.0 mg once daily over 68 weeks and reported a mean body-weight change of −15.8% with semaglutide versus −6.4% with liraglutide (PMID 35015037).

Studied but not approved on the Ozempic label

Several semaglutide trials have been published in populations or at doses that do not correspond to any current Ozempic indication. Presenting these as approved uses would be inaccurate; they are described here so the distinction is clear.

Higher-dose weekly semaglutide in obesity

The STEP UP phase 3b trial randomised adults with obesity to once-weekly semaglutide 7.2 mg, semaglutide 2.4 mg or placebo, and researchers reported greater mean body-weight reduction with 7.2 mg than with 2.4 mg or placebo at the end of the 72-week treatment period (PMID 40961952). A companion trial, STEP UP T2D, applied the same 7.2 mg weekly dose in adults with obesity and type 2 diabetes and reported greater body-weight reduction than placebo (PMID 40961953). The 7.2 mg dose was investigational in both trials.

Prediabetes

STEP 10 was a randomised, double-blind, placebo-controlled phase 3 trial in people with obesity and prediabetes, in which researchers assessed once-weekly semaglutide 2.4 mg against placebo and reported a higher proportion of participants reaching normoglycaemia in the semaglutide group (PMID 39089293). Prediabetes is not an approved Ozempic indication.

Metabolic dysfunction-associated steatohepatitis (MASH)

A phase 3 trial of once-weekly semaglutide 2.4 mg in adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis reported higher rates of steatohepatitis resolution without worsening of fibrosis, and of fibrosis improvement without worsening of steatohepatitis, than placebo (PMID 40305708). A regulatory action in this indication in 2025 applied to the higher-dose weekly semaglutide product marketed for weight management, not to the Ozempic label.

High-dose oral semaglutide for weight management

The OASIS 1 trial tested oral semaglutide 50 mg once daily against placebo in adults with overweight or obesity over 68 weeks, and researchers reported significantly greater body-weight reduction with the active treatment (PMID 37385278). Ozempic is an injectable product; oral formulations are regulated separately.

Adverse Events: What Studies Report

A dedicated safety review of semaglutide reported that gastrointestinal events — nausea, vomiting, diarrhoea and constipation — were the most frequently observed adverse effects across the clinical programme, were generally mild to moderate, and tended to be most prominent during dose escalation; the same review discussed the rodent thyroid C-cell tumour findings that underpin the boxed warning carried by GLP-1 receptor agonists of this type (PMID 34305810). In STEP 2, researchers reported that gastrointestinal adverse events were more common with semaglutide 2.4 mg than with placebo and were the leading reason for treatment discontinuation (PMID 33667417). STEP 8 similarly reported that gastrointestinal adverse events occurred in the majority of participants in both the semaglutide and liraglutide groups (PMID 35015037). In the higher-dose STEP UP trial, researchers reported that gastrointestinal events were the most common adverse events with semaglutide 7.2 mg and were mostly mild to moderate (PMID 40961952).

Trial-reported adverse-event rates describe what happened in selected study populations under monitoring. They are not a safety assessment for any individual, and contraindications, warnings and monitoring requirements are set out in the approved product information.

How to read “approved for” claims

• Brand matters. Semaglutide products share an active ingredient but not a label. An indication approved for one brand is not approved for another.
• Country matters. The cardiovascular and kidney indications were added to US labelling on specific dates; wording and timing differ elsewhere.
• Dose matters. Doses studied in trials, such as the 7.2 mg weekly regimen reported in STEP UP, are not automatically approved doses (PMID 40961952).
• Prescribing outside the label happens. Clinicians may legally prescribe an approved medicine outside its labelled indication in many jurisdictions; that practice does not convert an off-label use into an approved one.

Questions this page does not answer

Whether a medicine is appropriate for a particular person, how it interacts with other treatments, what monitoring is required, and whether any labelled indication applies to an individual case are clinical judgements. They depend on diagnosis, comorbidities, kidney and liver function, pregnancy status, personal and family medical history, and local prescribing rules. This page is for educational purposes only and is not medical advice; consult a licensed physician or qualified prescriber about any medicine, including semaglutide, and rely on the current approved product information for your country rather than on summaries of the literature.

References

• The Discovery and Development of Liraglutide and Semaglutide (Frontiers in Endocrinology, 2019)
• GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art (Molecular Metabolism, 2021)
• Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2) (Lancet, 2021)
• 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)
• Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight (STEP 8) (JAMA, 2022)
• Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1) (Lancet, 2023)
• Efficacy and safety of once-weekly semaglutide 2·4 mg versus placebo in people with obesity and prediabetes (STEP 10) (Lancet Diabetes & Endocrinology, 2024)
• Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis (New England Journal of Medicine, 2025)
• Once-weekly semaglutide 7·2 mg in adults with obesity (STEP UP) (Lancet Diabetes & Endocrinology, 2025)
• Once-weekly semaglutide 7·2 mg in adults with obesity and type 2 diabetes (STEP UP T2D) (Lancet Diabetes & Endocrinology, 2025)