INDIANAPOLIS, U.S., Aug 28, 2026

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved Mounjaro (tirzepatide) to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who are at high risk for cardiovascular events. The expanded indication covers cardiovascular death, non-fatal heart attack and non-fatal stroke, adding an important cardiovascular benefit to Mounjaro’s established use for improving blood glucose levels. The FDA decision strengthens the clinical profile of tirzepatide as a dual GIP and GLP-1 receptor agonist and expands its role in cardiometabolic disease management. Mounjaro is already approved, alongside diet and exercise, to improve blood sugar in adults and children aged 10 years and older with type 2 diabetes.

FDA Expands Mounjaro’s Cardiovascular Indication

The FDA approval allows Mounjaro to be used to lower the risk of major cardiovascular events in adults with type 2 diabetes who are considered at high risk. The regulatory decision is significant because cardiovascular disease remains a major concern among people living with type 2 diabetes, and Lilly estimates that as many as one in three U.S. adults with type 2 diabetes may have undetected cardiovascular disease. Mounjaro is a single molecule that activates receptors for GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1). The medicine was previously established for its blood glucose and weight-related benefits, while the new indication adds cardiovascular risk reduction based on outcomes from the company’s large cardiovascular clinical development program. The approval specifically includes reducing the risk of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke, providing an additional therapeutic objective for high-risk adults with type 2 diabetes.

SURPASS-CVOT Delivers Long-Term Cardiovascular Data

The FDA decision was supported by results from SURPASS-CVOT, a randomized, double-blind, Phase 3 cardiovascular outcomes trial comparing Mounjaro with Trulicity (dulaglutide), a GLP-1 treatment with established cardiovascular benefit. The study randomized 13,299 participants across 640 sites in 30 countries, making it the largest and longest tirzepatide study conducted to date. Participants received once-weekly subcutaneous Mounjaro at 15 mg or the maximum tolerated dose, or Trulicity at 1.5 mg. The primary endpoint was MACE-3, a composite measure of cardiovascular death, heart attack or stroke. During a median follow-up of 210.1 weeks, Mounjaro demonstrated non-inferiority to dulaglutide for reducing MACE-3. The estimated hazard ratio for time to first MACE was 0.92, with a 95.3% confidence interval of 0.83 to 1.01. Lilly reported an 8% lower rate of cardiovascular death, heart attack or stroke with Mounjaro compared with Trulicity. However, superiority over dulaglutide was not established, an important distinction when interpreting the trial findings and regulatory evidence.

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Tirzepatide Strengthens Cardiometabolic Treatment Strategy

The expanded indication represents an important milestone in the development of tirzepatide as a cardiometabolic therapy, linking glucose management with long-term cardiovascular risk reduction. SURPASS-CVOT was designed as a direct head-to-head cardiovascular outcomes trial between two incretin-based medicines and followed participants for approximately five years. Lilly reported that the safety and tolerability profile of Mounjaro was generally consistent with its established profile, with gastrointestinal adverse events among the most commonly reported reactions. These events were generally mild to moderate and occurred primarily during the dose-escalation period. The prescribing information also includes warnings regarding pancreatitis, hypoglycemia, serious allergic reactions, dehydration-related kidney problems, severe gastrointestinal problems and gallbladder complications. Mounjaro remains a prescription medicine administered by once-weekly subcutaneous injection, with approved strengths ranging from 2.5 mg to 15 mg per 0.5 mL. The regulatory milestone also has broader implications for diabetes drug development and cardiovascular outcomes research, as SURPASS-CVOT provides long-term evidence from a large international population with established atherosclerotic cardiovascular disease. The trial results have been incorporated into Mounjaro’s product information in the European Union, while regulatory submissions based on the cardiovascular outcomes data remain under review in additional markets. The FDA approval therefore expands Mounjaro’s approved therapeutic role in the United States and adds cardiovascular risk reduction to its established glucose-lowering indication.

Source: Eli Lilly press release