For better or worse: Wegovy’s latest trial highlights 3 clinical innovation trends

Wegovy’s latest trial results provide promising evidence that the weight-loss drug may help improve symptoms and physical function in patients with obesity and heart failure. Advisory Board‘s Rachael Peroutky and Kara Marlatt explain how this trial advances three trends in clinical innovation — for better or worse. 

New trial finds Wegovy may benefit patients with heart failure

Last month, preliminary results of a large-scale clinical trial showed that Novo Nordisk‘s weight-loss drug Wegovy reduced the risk of heart attacks, strokes, and cardiovascular deaths by 20% among overweight and obese patients. Now, findings from a new study published in the New England Journal of Medicine suggest that the drug may have additional cardiovascular benefits.

In the study, which was conducted between March 2021 and March 2022, researchers enrolled 529 patients with obesity and heart failure with preserved ejection fraction (HFpEF). According to STAT+, HFpEF makes up around half of all heart failure cases. Patients also typically have chronic comorbidities, including diabetes and obesity, and may have difficulties performing daily tasks due to fatigue and shortness of breath.

Among the patients, over half were women, two-thirds were severely obese, and 95.8% were white. The median age was 69 years old. Half of the patients received Wegovy, and half of the patients received a placebo.

Overall, patients who took Wegovy lost 13.3% of their weight during the study period compared to 2.6% weight loss in the placebo group. Patients on Wegovy also saw greater improvement in the heart failure symptoms and physical limitations.

Compared to the placebo group, patients on Wegovy scored 7.8 points higher on the Kansas City Cardiomyopathy Questionnaire, which measure a patient’s physical function and quality of life. Patients on Wegovy also had a 20-meter greater improvement on a six-minute walk test, as well as lower blood pressure and reduced inflammation.

Although the study did not directly measure hospitalization and deaths among the patients, fewer patients in the Wegovy group were hospitalized or died compared to the placebo group. In total, 12 patients in the placebo group were hospitalized or had an urgent visit for heart failure compared to one patient in the Wegovy group. In addition, three patients in the Wegovy group died while four patients in the placebo group died. 

According to Mikhail Kosiborod, a cardiologist at St. Luke’s Mid America Heart Institute who led the study, Wegovy “has the real potential to be a fundamental paradigm shift in how we manage obesity patients with this type of heart failure.”

“We believe the benefit [of Wegovy] is multifactorial,” Kosiborod said. “Part of it is due to weight loss, and part of it is likely due to other mechanisms.”

According to Novo Nordisk, another trial testing Wegovy in HFpEF patients with obesity and diabetes is expected to be completed in the fourth quarter of this year. If the data supports Wegovy’s benefit in this group, the company said it plans to file for the drug’s label to be updated to reflect its use for cardiovascular conditions in the United States and Europe in the first half of 2024. (Chen, STAT+ [subscription required], 8/25; Muller/Kresge, Bloomberg, 8/25; Loftus, Wall Street Journal, 8/25)