Lilly’s blockbuster GLP-1 tirzepatide appears poised to become the next major HFpEF drug, after topline results from the SUMMIT trial showed that it significantly improved both outcomes and symptoms among patients with heart failure with preserved ejection fraction and obesity.
- Although often referred to as a GLP-1, tirzepatide uniquely activates both GIP and GLP-1 hormone receptors.
- Tirzepatide has already gained FDA approval for type 2 diabetes and obesity, while achieving greater weight loss than Novo Nordisk’s semaglutide in trials.
- Semaglutide has already been approved as a CVD risk-reducer, and these results suggest that tirzepatide is on a similar path for HFpEF.
Lilly’s Phase 3 SUMMIT trial gave either tirzepatide (5 mg, 10 mg or 15 mg) or placebo to 731 adults with HFpEF and obesity, finding that the tirzepatide group….
- Had a 38% lower risk of major HF events after two years (composite of first urgent HF visit, HF hospitalization, oral diuretic intensification, and CV death).
- Achieved improvements in heart failure symptoms and physical limitations at one year (+24.8 vs. +15 KCCQ-CSS points).
- Met all secondary endpoints through one year, including longer 6-minute walk distances, reduced hsCRP levels, and greater weight loss (-15.7% vs. -2.2%).
- Showed that tirzepatide was safe and well-tolerated, matching previous trials.
These topline results were widely viewed as another sign of GLP-1s’ massive cardiovascular potential, sparking a frenzy on CardioTwitter, and widespread media coverage, while driving a solid 4% single-day surge to Lilly’s already insanely-high stock price.
This excitement seems justified given the major impact GLP-1s are already having across healthcare, and noting that Novo Nordisk’s semaglutide quickly gained regulatory approval and payor coverage after it similarly showed its impact on cardiovascular events.
- Lilly isn’t at that stage yet with tirzepatide, but it does plan to submit the SUMMIT trial results to regulators later this year, suggesting that a HFpEF approval might be coming in 2025.
- In fact, Lilly might have company in the HFpEF arena, as Novo Nordisk’s STEP-HFpEF trial showed that semaglutide similarly impacts quality-of-life symptoms, although the trial didn’t evaluate HF outcomes.
The Takeaway
The hottest drug class in the world just got even hotter, as the SUMMIT trial appears to show that tirzepatide could improve millions of HFpEF patients’ lives and outcomes – a revelation that could lead to the drug’s expanded approval, coverage, usage, and overall impact.
