Clinical Data Demonstrating Efficacy of Sotagliflozin in Preserved Ejection Fraction Heart Failure (HFpEF) without Diabetes Presented at American Heart Association (AHA) Annual Scientific Sessions 2025

Oral presentation highlights sotagliflozin's unique benefits to HFpEF patients in significantly improving cardiac and physical performance, and quality of life

THE WOODLANDS, Texas, Nov. 08, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that new sotagliflozin clinical data was presented at the AHA Annual Scientific Sessions 2025. The data highlighted benefits observed from sotagliflozin treatment in heart failure patients with preserved ejection fraction (HFpEF), and without diabetes, across a range of measures, including cardiac structure and function, quality of life and functional capacity.

Conducted under the direction of Dr. Juan J Badimon, PhD, FACC, FAHA, director, Atherothrombosis Research Unit, professor of Medicine/Cardiology at Mount Sinai Medical Center in New York City, “SOTA P CARDIA: A Randomized Trial of Sotagliflozin in HFpEF Patients without Diabetes” was a prospective, randomized, double-blind, placebo-controlled trial that exclusively enrolled patients with HFpEF, the most rapidly increasing form of heart failure.

The objective of the study was to compare treatment with sotagliflozin to placebo on a number of cardiac functional and structural measures, such as left ventricular mass, diastolic function, standard six-minute walk test, and KCCQ. The study enrolled 88 participants who were racially diverse and 70 percent female. Patients were treated with sotagliflozin or placebo for six months, and comparisons were made between groups during and after completion of treatment.

Treatment with sotagliflozin resulted in statistically significant improvements in left ventricular mass, diastolic function, capacity for a six-minute walk test, and KCCQ measurements. In addition, though peak VO₂ improvement did not achieve statistical significance, there was a notable improvement after treatment with sotagliflozin.

“The benefits observed with sotagliflozin treatment in the study include significant improvements in cardiac structure and function, symptom relief and, most importantly, quality of life and functional capacity,” said Dr. Badimon. “Although sotagliflozin was approved more than two years ago for heart failure patients with or without diabetes, our study is the first to demonstrate important clinical benefits for patients with preserved ejection fraction without diabetes.”