The US Food and Drug Administration has approved Mounjaro, Eli Lilly's tirzepatide injection, to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk of them. Lilly announced the decision on 28 August 2026. The indication covers cardiovascular death, non-fatal heart attack and non-fatal stroke. It rests on SURPASS-CVOT, a trial that randomised 13,299 adults with type 2 diabetes and established atherosclerotic cardiovascular disease at 640 sites across 30 countries, with a median follow-up of 210.1 weeks, close to four years. Unlike most cardiovascular outcome trials, it did not use a placebo comparator: participants were compared against dulaglutide, sold as Trulicity, a GLP-1 medicine that already carries an established cardiovascular benefit. Tirzepatide is the first dual GIP and GLP-1 receptor agonist to gain an approval of this kind. The decision applies to the US label.
Non-inferior, not superior
The trial met its primary endpoint on non-inferiority rather than superiority. Mounjaro returned a hazard ratio of 0.92 against dulaglutide on the three-part composite of cardiovascular death, heart attack or stroke, with a 95.3 per cent confidence interval running from 0.83 to 1.01, an 8 per cent lower rate. Because that interval crosses 1.0, superiority over dulaglutide was not established, and the result should be read as one incretin performing at least as well as another rather than better. The most common adverse events reported were gastrointestinal, including nausea, diarrhoea, decreased appetite, vomiting and constipation, mostly mild to moderate and concentrated during dose escalation. Lilly makes both medicines compared.
What this means in practice
This is a United States labelling decision and it does not change the UK licence. In Great Britain the MHRA authorised tirzepatide for type 2 diabetes, then on 8 November 2023 for weight management in adults with a BMI of 30 or above, or between 27 and 30 alongside a weight-related health problem. Neither of those UK authorisations mentions cardiovascular risk reduction, and no equivalent MHRA decision has been announced. Nothing about the US approval changes what a UK prescriber can currently put on a prescription, and questions about a prescribed GLP-1 medicine belong with that prescriber rather than with a label update from another regulator. No food supplement is involved in this story.
How Perqen members save
Perqen membership costs £4.99 a month or £29.99 a year and unlocks member pricing across the full Perqen catalogue, while non-members can still buy at standard prices. The membership page sets out what the fee covers.
This article reports published news and research and is for information only. Food supplements are not a substitute for a varied diet or medical care, and no product mentioned is intended to diagnose, treat, cure or prevent any disease. Speak to your GP or pharmacist before changing what you take, especially if you are pregnant, breastfeeding, or taking prescribed medicines.
Sources
- FDA approves Lilly's Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes (Eli Lilly, 28 August 2026)
- Mounjaro approved to reduce cardiovascular events in adults with diabetes (Healio, 28 August 2026)
- MHRA authorises diabetes drug Mounjaro (tirzepatide) for weight management and weight loss (GOV.UK)