Novo Nordisk's Weight Loss Treatment Shows Benefit In Patients With Most Common Type Of Heart Failure

Novo Nordisk A/S NVO announced results from the phase 3 STEP HFpEF trial of once-weekly semaglutide 2.4 mg in adults with heart failure with preserved ejection fraction (HFpEF).

Wegovy (once-weekly subcutaneous semaglutide 2.4 mg) is a GLP-1 receptor agonist indicated for chronic weight management and is launched in the U.S., Denmark, Norway, and Germany.

64 million people are living with heart failure worldwide. HFpEF is now the most common form of heart failure.

Earlier this month, Novo Nordisk released the headline results from the SELECT cardiovascular outcomes trial that compared subcutaneous once-weekly semaglutide 2.4 mg with placebo as an adjunct to the standard of care to prevent major adverse cardiovascular events (MACEs), such as stroke, for up to five years. 

The findings show a large improvement in patient-reported Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), measuring the symptoms and physical limitations of HFpEF.

The mean change in the KCCQ-CSS was a 16.6-point increase at 52 weeks with semaglutide 2.4 mg vs. 8.7 points with placebo, leading to an estimated treatment difference of 7.8 points. 

The mean change in body weight was 13.3% reduction with semaglutide 2.4 mg vs. 2.6% reduction with placebo, leading to an estimated treatment difference of 10.7% weight reduction.

STEP HFpEF also demonstrated a mean increase in 6-Minute Walking Distance (6MWD) of 21.5 meters at 52 weeks with semaglutide vs. 1.2 meters with placebo, leading to an estimated treatment difference of 20.3 meters. Semaglutide also reduced inflammation.

The ongoing STEP HFpEF-DM trial – another study of HFpEF and obesity in people with type 2 diabetes – will be included in the regulatory submission. 

STEP HFpEF-DM is expected to be completed in Q4 2023, and subject to positive outcomes, Novo Nordisk expects to file for approval of the Wegovy label update in the U.S. and EU in 1H of 2024.

Price Action: NVO shares are down 0.28% at $184.83 during the premarket session on the last check Friday.