On November 16, at the 100th American Heart Association (AHA) Scientific Sessions 2024 in Chicago, Illinois, US, results were presented from the SUMMIT trial (NCT04847557), which evaluated the impact of Eli Lilly’s tirzepatide in patients with obesity and heart failure with preserved ejection fraction (HFpEF) on the major heart failure outcomes. Tirzepatide is a long-acting dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 (GIP/GLP-1) receptor agonist. In addition to tirzepatide’s application in obesity and type 2 diabetes (T2D), it is also in pre-registration for obstructive sleep apnea, in Phase III for cardiovascular risk factors and HFpEF, and Phase II for metabolic dysfunction-associated steatohepatitis (MASH) and chronic kidney disease (CKD).

The SUMMIT trial consisted of two arms: the experimental arm (n = 364) involved subjects receiving tirzepatide, starting treatment at a once-weekly 2.5mg dose that followed a fixed-dose escalation regimen in which doses were increased every four weeks by 2.5mg until the maintenance dose of 15mg/week was reached by week 20. The second arm of the trial was the placebo arm (n = 367). The final primary endpoints of SUMMIT were a combination of adjudicated cardiovascular mortality or a worsening heart failure event (α = 0.04) and change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline to 52 weeks (α = 0.01). Key secondary endpoints included changes in body weight, 6-minute walk distance, and high sensitivity C-reactive protein (hsCRP).

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Milton Packer, MD, Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center at Dallas and Visiting Professor at Imperial College, London, reported the results of the SUMMIT trial with regard to the efficacy and safety of tirzepatide for the treatment of obesity-related HFpEF. On the primary endpoints of the study, combined cardiovascular mortality and worsening heart failure events (α = 0.04) were determined in 36 patients (9.9%) in the tirzepatide group, whereas in the placebo group, such events were reported in 56 patients (15.3%) (p = 0.026). The mean (±SD) change in KCCQ-CSS was 19.5±1.2 in the tirzepatide group, whereas in the placebo group, it was 12.7±1.3. The median difference in KCCQ-CSS between the tirzepatide and placebo arms of the study was 6.9 (3.3 to 10.6; p<0.001). Secondary endpoints of the study, including change in 6-minute walk distance scores and systemic inflammation as measured by hsCRP, were significantly and meaningfully improved with tirzepatide. As for the safety profile of tirzepatide in SUMMIT, results were comparable to those of previous clinical trials for tirzepatide; 4% of the experimental group discontinued treatment as a result of gastrointestinal symptoms.

Key opinion leaders (KOLs) interviewed by GlobalData have expressed that while GLP-1RAs have proven benefits in T2D and obesity, the patient’s weight is not the only thing that matters; cardiovascular disease outcome studies are of utmost significance. KOLs additionally emphasized the importance of educating patients on weight management and cardiovascular disease.

All in all, tirzepatide has the potential to be popular among HFpEF patients and clinicians alike, given its ability to reduce the combined risk of cardiovascular mortality and worsening heart failure and treat patients with HFpEF and obesity. Thus, tirzepatide is on a trajectory to provide a highly anticipated treatment for HFpEF patients.

According to GlobalData’s Pharma Intelligence Center, there are six Phase III candidates, 12 Phase II candidates, and eight Phase I candidates currently in development for HFpEF globally. There are 20 Phase III candidates, 70 Phase II candidates, and 91 Phase I candidates being studied for obesity globally.

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