Wegovy is under FDA review for a heart failure type tied to obesity

Wegovy (semaglutide) is under review at the U.S. Food and Drug Administration for heart failure with preserved ejection fraction, or HFpEF — a use that no GLP-1 medication currently holds ^[1]. The FDA has not reported a decision date, and it has not been disclosed when a ruling might come.

HFpEF accounts for more than half of all heart failure cases in the United States and is increasing in prevalence, and most people who have it also have overweight or obesity ^[2]. Obesity appears to contribute to the condition rather than simply accompany it, and patients with both tend to have a greater symptom burden, worse exercise capacity and more impaired quality of life than patients with HFpEF who are not obese ^[2]. No therapy has been approved to target obesity-related HFpEF ^[2].

The main evidence behind the review is the STEP-HFpEF trial, published in the New England Journal of Medicine ^[2]. Researchers randomly assigned 529 patients at 96 sites in 13 countries to once-weekly semaglutide 2.4 mg or placebo for 52 weeks ^[2]. Participants were 18 or older with a body-mass index of at least 30, an ejection fraction of at least 45%, and heart failure symptoms rated class II, III or IV. People with diabetes were excluded from the trial ^[2]. Novo Nordisk, which makes Wegovy, funded the study ^[2].

On the Kansas City Cardiomyopathy Questionnaire clinical summary score — a 0-to-100 scale where a higher score means fewer symptoms and physical limitations — the semaglutide group improved by 16.6 points and the placebo group by 8.7 points, an estimated difference of 7.8 points (95% confidence interval, 4.8 to 10.9) ^[2]. Body weight fell 13.3% with semaglutide and 2.6% with placebo, a difference of 10.7 percentage points ^[2]. Six-minute walk distance rose 21.5 meters with semaglutide versus 1.2 meters with placebo ^[2]. On a composite measure that included deaths, heart failure events and differences in symptom and walking improvements, semaglutide produced more wins than placebo, with a win ratio of 1.72 (95% CI, 1.37 to 2.15) ^[2]. C-reactive protein, a marker of inflammation, fell 43.5% with semaglutide and 7.3% with placebo ^[2]. Serious adverse events were reported in 35 people taking semaglutide (13.3%) and 71 taking placebo (26.7%) ^[2].

Why it matters for patients

If approved, Wegovy would be the first drug with an FDA-labeled use for obesity-related HFpEF, and no competing GLP-1 has that indication ^[1]. Labeled uses often shape what insurers cover and what clinicians can prescribe for a specific diagnosis, so a decision here could affect access and cost for people whose heart failure is being managed alongside their weight.

The trial enrolled a specific group: adults with HFpEF and obesity who did not have diabetes ^[2]. That is the population the results described above apply to. How semaglutide performs in people who have both HFpEF and diabetes has not been reported. Wegovy's existing FDA approval is for long-term weight management, and the HFpEF review does not change what is currently available ^[2].

What happens next

No decision date on the HFpEF review has been reported. Other GLP-1 milestones that could land in 2026 include an FDA review of a higher Wegovy injection dose of 7.2 mg, which in trials produced nearly 19% average weight loss, and about 21% among people who stayed on treatment ^[1]. Ozempic is also under review for peripheral artery disease ^[1]. Orforglipron, an oral non-peptide GLP-1, could be approved in the second quarter of 2026, and CagriSema — cagrilintide combined with semaglutide — has an FDA response expected sometime in 2026 ^[1]. The Wegovy pill launched in January 2026 ^[1].