Eli Lilly’s Mounjaro approved by FDA to reduce cardiovascular risk in adults with type 2 diabetes

Regulatory approval

The FDA approved Mounjaro (tirzepatide), a dual GIP and GLP‑1 receptor agonist, to lower the risk of major adverse cardiovascular events (MACE) — cardiovascular death, non‑fatal heart attack or non‑fatal stroke — in adults with type 2 diabetes who are at high risk for these events. Mounjaro is already approved as an adjunct to diet and exercise to improve blood sugar in adults and children 10 years and older.

Evidence from SURPASS‑CVOT

SURPASS‑CVOT was the first cardiovascular outcomes trial to compare two incretin medicines head‑to‑head. The event‑driven, randomized, double‑blind Phase 3 trial enrolled 13,299 participants (1:1 randomization) across 640 sites in 30 countries and ran approximately five years with a median follow‑up of 210.1 weeks. Mounjaro (15 mg or maximum tolerated dose) demonstrated non‑inferiority to Trulicity (dulaglutide 1.5 mg) for MACE‑3, with a hazard ratio of 0.92 (95.3% CI: 0.83–1.01) and an 8% lower rate; statistical superiority was not established. Full results were published in The New England Journal of Medicine.

Safety, warnings and dosing

Safety in SURPASS‑CVOT was generally consistent with Mounjaro’s established profile; the most common adverse events were gastrointestinal and typically mild‑to‑moderate during dose escalation. Prescribing information lists warnings including potential thyroid tumours, pancreatitis, hypoglycaemia risk when combined with insulin or sulfonylureas, serious allergic reactions, dehydration/renal effects, gallbladder problems and increased aspiration risk with anesthesia. Common side effects include nausea, diarrhea, decreased appetite, vomiting, constipation and abdominal pain. Mounjaro is supplied as a weekly pre‑filled pen in strengths from 2.5 mg to 15 mg per 0.5 mL.