Lilly's Mounjaro Shows Promise in Cardiovascular Outcomes Trial, Matching Trulicity's Performance

Eli Lilly's blockbuster diabetes drug Mounjaro (tirzepatide) has demonstrated its cardiovascular benefits in a large-scale Phase III trial, positioning the company to seek expanded approval for reducing heart risks in patients with type 2 diabetes.

SURPASS-CVOT Trial Results

The highly anticipated SURPASS-CVOT trial, which enrolled over 13,000 adults with type 2 diabetes and established atherosclerotic cardiovascular disease, showed that Mounjaro was non-inferior to Lilly's older GLP-1 therapy Trulicity (dulaglutide) in reducing major adverse cardiovascular events (MACE-3). The primary endpoint, which included cardiovascular death, heart attack, or stroke, was met with an 8% lower risk for Mounjaro compared to Trulicity.

While Mounjaro did not achieve statistical superiority over Trulicity on the primary endpoint, it demonstrated a 16% lower rate of all-cause mortality. Kenneth Custer, Lilly's head of cardiometabolic health, expressed confidence in the data, stating, "We feel very, very confident in these data."

Secondary Endpoints and Additional Benefits

Mounjaro showed compelling results on secondary endpoints, including greater reductions in A1C levels and body weight compared to Trulicity. At 36 months, Mounjaro reduced A1C levels by 1.73% from baseline, while Trulicity achieved a 0.90% reduction. Patients taking Mounjaro lost an average of 25.2 lbs, compared to 10.25 lbs for those on Trulicity.

The trial also indicated improvements in kidney function for Mounjaro patients, although these data were not adjusted for multiple hypothesis testing. Side effects were mainly gastrointestinal and generally mild to moderate, with a slightly higher discontinuation rate due to side effects in the Mounjaro group (13%) compared to Trulicity (10%).

Regulatory Implications and Market Position

Lilly intends to submit the SURPASS-CVOT data to global regulatory authorities by the end of this year, potentially leading to expanded approval for Mounjaro in preventing cardiovascular events. This move could strengthen Mounjaro's position in the competitive GLP-1 market, where it faces competition from Novo Nordisk's semaglutide (sold as Ozempic for diabetes and Wegovy for weight loss).

The results, while not demonstrating superiority, are expected to support Mounjaro's continued preference among physicians and patients over other GLP-1 therapies. Leerink Partners analysts noted that the findings, particularly the all-cause mortality reduction, suggest "more comprehensive health benefits" for Mounjaro.

As Lilly prepares to report its second-quarter earnings on August 7, the company remains on a strong trajectory, having reported a 45% revenue increase to $12.73 billion in Q1, driven by growth from Mounjaro and obesity treatment Zepbound. The SURPASS-CVOT results are likely to further solidify Lilly's position in the rapidly evolving diabetes and obesity treatment landscape.