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

Tirzepatide is a prescription medicine, a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist marketed under two brand names: Mounjaro for the diabetes indication and Zepbound for the weight-management and sleep-apnoea indications in the United States. Its approved indications are defined by national regulators, and each one rests on a specific set of randomised phase 3 trials. This page separates what is written on the label from what has only been studied. This page is for educational purposes only and is not medical advice; consult a licensed physician about whether any approved indication applies to an individual situation. A broader overview of the molecule sits on the tirzepatide learn hub.

Approved Indications at a Glance

Label wording, body-mass-index thresholds and the exact populations differ between jurisdictions, and only a prescribing clinician with access to the current local product information can say which indication, if any, is relevant to a given person.

Indication 1: Glycaemic Control in Adults With Type 2 Diabetes

The first approval, granted by the US Food and Drug Administration in May 2022, covers use as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. The supporting evidence came from the SURPASS programme.

In SURPASS-1, researchers randomised adults with type 2 diabetes not on background glucose-lowering therapy to once-weekly tirzepatide 5 mg, 10 mg or 15 mg or placebo, and the study reported mean HbA1c reductions of 1.87%, 1.89% and 2.07% with tirzepatide compared with an increase of 0.04% on placebo at 40 weeks (PMID 34186022). In SURPASS-2, an open-label active-comparator trial, researchers reported mean HbA1c changes of −2.01%, −2.24% and −2.30% with tirzepatide 5 mg, 10 mg and 15 mg versus −1.86% with semaglutide 1 mg, and mean body-weight changes of −7.6 kg, −9.3 kg and −11.2 kg versus −5.7 kg at 40 weeks (PMID 34170647).

SURPASS-5 examined the add-on setting: tirzepatide or placebo added to titrated insulin glargine in adults with inadequately controlled type 2 diabetes, where the study reported mean HbA1c reductions of 2.11%, 2.40% and 2.34% with tirzepatide 5 mg, 10 mg and 15 mg compared with 0.86% with placebo at 40 weeks (PMID 35133415). Collectively these registration trials established glycaemic efficacy across monotherapy, active-comparator and insulin add-on settings (PMID 34186022, PMID 35133415).

Indication 2: Chronic Weight Management in Adults

In November 2023 the FDA approved tirzepatide under the brand name Zepbound for chronic weight management in adults with obesity, or with overweight plus at least one weight-related comorbid condition, as an adjunct to a reduced-calorie diet and increased physical activity. European and UK regulators added comparable weight-management indications to the existing product during 2023.

SURMOUNT-1 was the pivotal trial: in adults with obesity or overweight without diabetes, researchers reported mean percentage changes in body weight of −15.0%, −19.5% and −20.9% with tirzepatide 5 mg, 10 mg and 15 mg versus −3.1% with placebo at 72 weeks (PMID 35658024). SURMOUNT-2 tested the same question in adults with obesity and type 2 diabetes, where the study reported mean weight reductions of 12.8% with 10 mg and 14.7% with 15 mg compared with 3.2% on placebo at 72 weeks (PMID 37385275).

SURMOUNT-4 addressed what happened when treatment continued or stopped: after a 36-week open-label lead-in, participants randomised to continue tirzepatide had a further mean weight reduction of 5.5% over the following 52 weeks, whereas those switched to placebo regained a mean of 14.0% (PMID 38078870). SURMOUNT-CN, conducted in Chinese adults with obesity, reported least-squares mean weight changes of −13.6% with 10 mg and −17.5% with 15 mg versus −2.3% with placebo at 52 weeks and supported regional registration (PMID 38819983).

Indication 3: Moderate-to-Severe Obstructive Sleep Apnoea With Obesity

In December 2024 the FDA approved an additional indication for moderate-to-severe obstructive sleep apnoea in adults with obesity — the first drug indication of its kind. The SURMOUNT-OSA programme comprised two 52-week randomised trials, one in participants not using positive airway pressure therapy and one in participants using it, and researchers reported mean reductions in the apnoea–hypopnoea index of 25.3 and 29.3 events per hour with tirzepatide compared with 5.3 and 5.5 events per hour with placebo (PMID 38912654). The label frames the indication alongside a reduced-calorie diet and increased physical activity, and the trials enrolled adults who also met obesity criteria (PMID 38912654).

Studied but Not Approved: Investigational and Off-Label Uses

Several areas appear frequently in the tirzepatide literature. None of the following is an approved indication, and describing a trial result is not the same as describing a label.

Prevention of type 2 diabetes in people with prediabetes

A long-term extension of SURMOUNT-1 followed adults with obesity or overweight and prediabetes for 176 weeks, where researchers reported mean percentage weight changes of −12.3%, −18.7% and −19.7% with tirzepatide 5 mg, 10 mg and 15 mg versus −1.3% with placebo, and a hazard ratio of 0.07 for progression to type 2 diabetes compared with placebo (PMID 39536238). Diabetes prevention is a trial endpoint in that report, not a licensed indication (PMID 39536238).

Metabolic dysfunction-associated steatotic liver disease

The 2024 EASL-EASD-EASO clinical practice guidelines on metabolic dysfunction-associated steatotic liver disease placed weight reduction at the centre of management and discussed incretin-based obesity pharmacotherapy within that framework rather than as an approved liver-disease treatment (PMID 38851997).

Children and adolescents

The approved indications described above are written for adults. SURPASS-PEDS, a randomised, double-blind, placebo-controlled phase 3 trial, evaluated tirzepatide in children and adolescents with type 2 diabetes and researchers reported greater reductions in HbA1c with tirzepatide than with placebo (PMID 40975112). Whether and when any paediatric indication is added is a matter for regulators.

Preconception and pregnancy

A 2025 review examined preconception use of GLP-1 and GLP-1/GIP receptor agonists for obesity treatment and discussed the uncertainties around timing, contraception and the absence of pregnancy outcome data (PMID 41015723). This remains an area of clinical discussion rather than an approved use (PMID 41015723).

Adverse Events in the Approval Trials: What Studies Report

Across the registration programme, gastrointestinal effects dominated the safety profile. In SURPASS-1, researchers reported that the most common adverse events were mild-to-moderate, transient gastrointestinal events including nausea, diarrhoea and vomiting (PMID 34186022). SURMOUNT-1 similarly reported that the most frequent adverse events with tirzepatide were gastrointestinal, primarily mild to moderate in severity and occurring mainly during dose escalation, with more participants discontinuing because of adverse events on tirzepatide than on placebo (PMID 35658024).

In the insulin add-on setting, SURPASS-5 reported hypoglycaemia events among participants receiving tirzepatide alongside titrated insulin glargine as well as placebo (PMID 35133415). The sleep-apnoea trials reported that the most common adverse events with tirzepatide were gastrointestinal and generally mild to moderate (PMID 38912654). Approved labels also carry boxed warnings and contraindications — including those relating to thyroid C-cell tumours observed in rodents and to personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 — which are set out in the official product information and reviewed by a prescribing clinician.

How to Read the Gap Between Label and Literature

1. An indication names a population, not just a disease. The weight-management indication specifies adults meeting body-mass-index criteria, and the sleep-apnoea indication specifies adults who also have obesity (PMID 38912654).
2. Trial endpoints are not indications. Reduced progression to type 2 diabetes was measured in a trial extension (PMID 39536238); it does not appear as a licensed use.
3. Regional labels diverge. Chinese registration drew on a dedicated trial in Chinese adults (PMID 38819983), and approved wording differs by country.
4. Withdrawal data belong to the label discussion. SURMOUNT-4 reported substantial weight regain after switching from tirzepatide to placebo, which informs how clinicians frame long-term treatment decisions (PMID 38078870).

Questions about eligibility, duration, interactions, monitoring and whether any of these indications fits a particular medical history are clinical decisions and belong with a licensed prescriber who can review the current product information.

References

• Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial (Lancet, 2021)
• Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes (New England Journal of Medicine, 2021)
• Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes: The SURPASS-5 Randomized Clinical Trial (JAMA, 2022)
• Tirzepatide Once Weekly for the Treatment of Obesity (New England Journal of Medicine, 2022)
• Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial (Lancet, 2023)
• Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial (JAMA, 2024)
• Tirzepatide for Weight Reduction in Chinese Adults With Obesity: The SURMOUNT-CN Randomized Clinical Trial (JAMA, 2024)
• Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity (New England Journal of Medicine, 2024)
• EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD) (Journal of Hepatology, 2024)
• Tirzepatide for Obesity Treatment and Diabetes Prevention (New England Journal of Medicine, 2025)
• Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial (Lancet, 2025)
• Preconception use of GLP-1 and GLP-1/GIP receptor agonists for obesity treatment (Best Practice & Research Clinical Endocrinology & Metabolism, 2025)