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
Lexicon Pharmaceuticals (Nasdaq: LXRX) reported new clinical data presented at AHA 2025 showing sotagliflozin produced statistically significant improvements in cardiac structure, diastolic function, six-minute walk distance and KCCQ scores in patients with preserved ejection fraction heart failure (HFpEF) without diabetes.
The prospective, randomized, double-blind, placebo-controlled SOTA P CARDIA trial enrolled 88 racially diverse participants (70% female) treated for six months. Peak VO2 improved but did not reach statistical significance. The company highlighted these results as the first demonstration of clinical benefit for HFpEF patients without diabetes.
Lexicon Pharmaceuticals (Nasdaq: LXRX) ha comunicato nuovi dati clinici presentati all'AHA 2025 che mostrano che sotagliflozin ha prodotto miglioramenti statisticamente significativi nella struttura cardiaca, nella funzione di diastole, nella distanza percorsa in sei minuti e nei punteggi KCCQ nei pazienti con insufficienza cardiaca con frazione di eiezione preservata (HFpEF) senza diabete.
Lo studio prospettico, randomizzato, in doppio cieco, controllato con placebo SOTA P CARDIA ha arruolato 88 partecipanti di diversa origine etnica (70% femmine) trattati per sei mesi. La VO2 di picco è migliorata ma non ha raggiunto significatività statistica. L'azienda ha sottolineato che questi risultati rappresentano la prima dimostrazione di beneficio clinico per i pazienti con HFpEF senza diabete.
Lexicon Pharmaceuticals (Nasdaq: LXRX) comunicó nuevos datos clínicos presentados en AHA 2025 que muestran que sotagliflozina produjo mejoras estadísticamente significativas en la estructura cardíaca, la función diastólica, la distancia recorrida en seis minutos y las puntuaciones KCCQ en pacientes con insuficiencia cardíaca con fracción de eyección preservada (HFpEF) sin diabetes.
El ensayo prospectivo, aleatorizado, doble ciego, controlado con placebo SOTA P CARDIA reclutó 88 participantes de diversas razas (70% mujeres) tratados durante seis meses. La VO2 pico mejoró pero no alcanzó significación estadística. La compañía destacó estos resultados como la primera demostración de beneficio clínico para pacientes con HFpEF sin diabetes.
Lexicon Pharmaceuticals (나스닥: LXRX)는 AHA 2025에서 발표된 새로운 임상 데이터를 통해 sotagliflozin이 당뇨병이 없는 보존된 박출계 HFpEF 환자에서 심장 구조, 이완 기능, 6분 걷기 거리 및 KCCQ 점수에서 통계적으로 유의한 향상을 보였다고 발표했습니다.
전향적, 무작위, 이중 맹검, 위약 대조 SOTA P CARDIA 시험은 인종적으로 다양한 88명의 참가자를 6개월 동안 치료했습니다. 피크 VO2가 개선되었으나 통계적으로 유의미하지 않았습니다. 회사는 이러한 결과를 당뇨병이 없는 HFpEF 환자에 대한 임상적 이익의 첫 번째 시연으로 강조했습니다.
Lexicon Pharmaceuticals (Nasdaq : LXRX) a présenté de nouvelles données cliniques lors de l'AHA 2025 montrant que la sotagliflozine a produit des améliorations statistiquement significatives de la structure cardiaque, de la fonction diastolique, de la distance parcourue en six minutes et des scores KCCQ chez des patients souffrant d'une insuffisance cardiaque à fraction d'éjection préservée (HFpEF) sans diabète.
L'essai prospectif, randomisé, en double aveugle et contrôlé par placebo SOTA P CARDIA a enrôlé 88 participants racialement divers (70% de femmes) traités pendant six mois. Le VO2 de pointe s'est amélioré mais n'a pas atteint la signification statistique. L'entreprise a souligné ces résultats comme la première démonstration d'un bénéfice clinique pour les patients HFpEF sans diabète.
Lexikon Pharmaceuticals (Nasdaq: LXRX) berichtete neue klinische Daten, die auf der AHA 2025 vorgestellt wurden und zeigen, dass Sotagliflozin statistisch signifikante Verbesserungen der Herzstruktur, der diastolischen Funktion, der Sechs-Minuten-Gehtdistanz und der KCCQ-Werte bei Patienten mit HFpEF ohne Diabetes bewirkt hat.
Die prospektive, randomisierte, doppelblinde, placebo-kontrollierte SOTA P CARDIA-Studie rekrutierte 88 rassisch vielfältige Teilnehmer (70% weiblich), die über sechs Monate behandelt wurden. Die maximale VO2 verbesserte sich, erreichte jedoch keine statistische Signifikanz. Das Unternehmen hob diese Ergebnisse als ersten Nachweis klinischer Vorteile für HFpEF-Patienten ohne Diabetes hervor.
أعلنت Lexicon Pharmaceuticals (نازدك: LXRX) عن بيانات سريرية جديدة عرضت في AHA 2025 تُظهر أن sotagliflozin حقّق تحسنات ذات دلالة إحصائية في بنية القلب، ووظيفة الانبساط، والمسافة المقطوعة في ست دقائق، ودرجات KCCQ لدى مرضى فشل القلب مع انخفاض وظيفة الانبعاث الاحتفاظ بالتصريف (HFpEF) من دون داء السكري.
اختبرت تجربة SOTA P CARDIA، وهي تجربة مستقبلية عشوائية مزدوجة التعمية وخاضعة لضبط بلاسيبو، 88 مشاركاً من خلفيات عرقية متنوعة (70% إناث) لمدة ستة أشهر. تحسن Peak VO2 ولكنه لم يصل إلى دلالة إحصائية. أشارت الشركة إلى أن هذه النتائج تمثل أول دليل على فائدة سريرية لمرضى HFpEF بدون داء السكري.
- Statistically significant improvement in left ventricular mass
- Statistically significant improvement in diastolic function
- Statistically significant improvement in six-minute walk capacity
- Statistically significant improvement in KCCQ quality-of-life scores
- Trial enrolled 88 participants, 70% female
- Peak VO2 improvement did not reach statistical significance
- Relatively small trial size: 88 participants
- Treatment and follow-up limited to six months
Insights
Randomized trial in 88 HFpEF patients without diabetes showed statistically significant improvements in cardiac structure, function, walk distance and KCCQ over six months.
The trial, "SOTA P CARDIA", randomized 88 racially diverse patients (70
Key dependencies and risks include the small sample size and short treatment duration; the findings are promising but limited to
Concrete items to watch over the next 6–24 months include publication of full data with exact p‑values and effect sizes, any larger confirmatory trials or regulatory filings that reference these results, and subgroup analyses given the 70
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.”
According to the American College of Cardiology, nearly 6.7 million Americans have heart failure, more than half with preserved ejection fraction. This condition often leads to frequent hospitalizations and has a one-year risk of death of roughly 25 percent.
“When you combine these study results with previously reported data on reductions among patients treated with sotagliflozin in the risks for MACE and rehospitalization following previous hospitalization for acute heart failure events, the potential for sotagliflozin to be considered a different class of medication starts to come into focus,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer.
Click here and search for “SOTA P CARDIA” to access the study abstract.
About Sotagliflozin
Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. Sotagliflozin is also currently under investigation for another cardiac condition, hypertrophic cardiomyopathy (HCM).
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, HCM, obesity, metabolism and other indications. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of sotagliflozin and its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
For Investor and Media Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com
FAQ
What did Lexicon announce about sotagliflozin in HFpEF on November 8, 2025 (LXRX)?
How large and how long was the SOTA P CARDIA trial for sotagliflozin (LXRX)?
Did sotagliflozin improve peak VO2 in the HFpEF trial presented at AHA 2025 (LXRX)?
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Does the SOTA P CARDIA trial show sotagliflozin benefits for HFpEF patients without diabetes (LXRX)?
