At the European Society of Cardiology (ESC) Congress 2024, results were presented from the SELECT trial, which evaluated the use of semaglutide for the treatment of obesity-related diastolic heart failure (HFpEF).
Semaglutide is one of the first highly anticipated glucagon-like peptide-1 receptor agonist (GLP-1RA) therapies. In addition to its application within obesity, type 2 diabetes (T2D), and cardiovascular risk factors, it is also in pre-registration for HFpEF, pre-registration for chronic kidney disease (CKD), Phase III for peripheral artery disease (PAD) and peripheral vascular disease (PVD), and in Phase II for acute ischemic stroke.
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Semaglutide is a GLP-1RA therapy that offers efficacy and treatment duration advantages within the obesity and T2D market, among others. It is a long-acting injectable therapy that is self-administered subcutaneously once per week. The SELECT trial comprised two arms. The experimental arm involved subjects receiving semaglutide, and starting treatment at a once-weekly 0.24mg dose that followed a fixed-dose escalation regimen, in which doses were increased every four weeks to doses of 0.5mg, 1.0mg, 1.7mg, and 2.4mg per week until the maintenance dose was reached after 16 weeks. Semaglutide was administered via subcutaneous injection once per week (on the same day of the week) as an adjunct to standard-of-care treatment for the duration of the trial. The second arm of the trial was the placebo arm, in which subjects received placebo at an equivalent dose to semaglutide once per week (on the same day of the week) as an adjunct to standard-of-care treatment for the duration of the trial.
Dr. Subodh Verma, FRCSC, FAHA, FCAHS, professor at the University of Toronto, Canada, and Canada Research Chair in Cardiovascular Surgery, reported the results of the SELECT trial with regards to the efficacy of semaglutide 2.4mg for the treatment of obesity-related HFpEF. Historical cases of myocardial infarction (MI) were less frequent in females than males, and stroke was more frequent in females than males at trial baseline.
The trial results showed that females with overweight or obesity and atherosclerotic cardiovascular disease (ASCVD), without diabetes, exhibited a lower risk of major adverse cardiovascular events (MACEs) than males, despite having comparable age, blood pressure, and hemoglobin A1C (HbA1c), but higher low-density lipoprotein cholesterol (LDL-C), high-sensitivity C-reactive protein (hsCRP), and body mass index (BMI). Additionally, compared to placebo, semaglutide achieved more significant reductions in body weight, waist circumference, and hsCRP in females than in males.
Conversely, the absolute risk reduction (ARR) was higher in males than in females. However, regarding cardiovascular, metabolic, and kidney endpoints, the efficacy of semaglutide was consistent by sex, regardless of MI, BMI, HbA1c, hsCRP, or estimated glomerular filtration rate (eGFR). Regarding the safety profile of semaglutide 2.4mg, while fewer females who received semaglutide experienced serious adverse events (SAEs) and adverse events (AEs) necessitating the discontinuation of treatment, the incidence of gastrointestinal (GI) AEs was comparable between males and females.
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By GlobalDataKey opinion leaders (KOLs) interviewed by GlobalData have expressed that while semaglutide facilitates T2D management and its weight loss benefits are good, the patient’s weight is not the only thing matters; the health of the patients matters too. KOLs added that cardiovascular disease outcome studies are of utmost significance.
All in all, it is clear that semaglutide has the potential to be popular among HFpEF patients and clinicians alike, given the promising results from its SELECT trial. Thus, semaglutide is on a trajectory to finally provide a long-awaited treatment for HFpEF patients.
According to GlobalData’s Pharma Intelligence Center, there are five Phase III candidates, 13 Phase II candidates, and five Phase I candidates for HPpEF globally. There are 20 Phase III candidates, 59 Phase II candidates, and 96 Phase I candidates for obesity globally.
