Lexicon Pharmaceuticals reported new analyses from its Phase 3 SOLOIST-WHF trial showing sotagliflozin’s efficacy in reducing cardiovascular deaths and heart failure-related events across different baseline systolic blood pressure ranges. The findings were presented at the ESC Congress 2026 in Munich.
The trial enrolled 1,222 patients with type 2 diabetes hospitalized for worsening heart failure, randomized to receive either sotagliflozin or a placebo. Results were stratified by baseline systolic blood pressure below 110 mmHg and at or above 110 mmHg. In patients with baseline systolic blood pressure below 110 mmHg, sotagliflozin reduced the combined risk of cardiovascular death and heart failure events with a hazard ratio of 0.56 (95% CI 0.33–0.95, p=0.03). For those with baseline systolic blood pressure at or above 110 mmHg, the hazard ratio was 0.69 (95% CI 0.53–0.91, p=0.01).
Craig Granowitz, Lexicon’s senior vice president and chief medical officer, noted that the treatment effect remained consistent across the full spectrum of baseline blood pressure levels. The drug, a dual SGLT1 and SGLT2 inhibitor, has been studied in approximately 20,000 patients across heart failure, diabetes, and chronic kidney disease indications. Lexicon is also investigating sotagliflozin for hypertrophic cardiomyopathy.
No significant differences were observed between treatment and placebo groups in hypotension-related adverse events (p=0.34) or acute kidney injury (p=0.69).
