While Eli Lilly’s diabetes blockbuster was non-inferior to its older incretin therapy Trulicity in a highly anticipated Phase III cardiovascular outcomes trial, analysts had hoped for statistical significance in reducing major events such as cardiovascular death, heart attack and stroke.
Eli Lilly’s blockbuster diabetes drug Mounjaro surpassed the results generated by its older incretin therapy Trulicity in a highly anticipated Phase III cardiovascular outcomes trial, reducing certain cardiovascular risks by 8%. However, it failed to demonstrate statistical superiority on this main outcome.
Mounjaro (tirzepatide) met the primary endpoint of the SURPASS-CVOT trial, which included more than 13,000 adults with both type 2 diabetes and established atherosclerotic cardiovascular disease, showing non-inferiority vs. Trulicity in lowering the rate of major adverse cardiovascular events (MACE-3) including cardiovascular death, heart attack or stroke. The rate of all-cause mortality was 16% lower for Mounjaro than for Trulicity.
In a note to investors Thursday morning, BMO Capital Markets’ Evan David Seigerman called the results “good enough.”
“We’ve consistently framed Trulicity as a very good drug for diabetic patients and [it] represents a tough bar to beat,” Seigerman wrote. “Still, we are encouraged by today’s results, especially with tirzepatide’s stat sig benefit (P=0.002) in time to all cause death.” However, Seigerman noted that Mounjaro failed to reach statistical superiority compared to Trulicity and added that the results are likely to be received negatively for Lilly’s shares.
In a Thursday morning note, Leerink Partners analysts focused on the trial’s secondary endpoints, which they called “compelling.”
Mounjaro demonstrated a greater reduction in A1C levels from baseline than Trulicity—1.73% vs. 0.90%—at 36 months, and patients taking Mounjaro lost an average of 25.2 lbs compared to 10.25 lbs on Trulicity, according to Lilly’s press release. The Leerink analysts added that the 16% all-cause mortality reduction suggests “more comprehensive health benefits.”
“Although we would have rather seen tirzepatide demonstrate statistically significant superiority on the primary endpoint, we see the results as supportive of tirzepatide continuing to be preferred by physicians and patients over other GLP-1s, including Trulicity,” they concluded.
Lilly intends to submit these data to global regulatory authorities by the end of this year. When asked by Endpoints News if the results are good enough to secure additional approvals for Mounjaro in preventing cardiovascular events, Kenneth Custer, the company’s head of cardiometabolic health, said, “We feel very, very confident in these data.”
On a roll so far this year, Lilly is set to report second-quarter earnings on August 7. In Q1, Lilly touted a 45% revenue increase to $12.73 billion, driven by growth from Mounjaro and obesity blockbuster Zepbound. Later in May, Lilly scored a win against archrival Novo Nordisk, with Zepbound eliciting greater weight loss than Novo Nordisk’s GLP-1 heavyweight Wegovy in the Phase IIIb SURMOUNT-5 study, while matching its safety.
On the cardiovascular front, Wegovy won FDA approval in March 2024 to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease who are obese or overweight—the first weight loss drug to secure this additional indication. The approval was backed by the Phase III SELECT trial, in which 2.4 mg of Wegovy led to a 20% drop in MACE compared to placebo when added to standard of care.
