Merck's enlicitide decanoate significantly reduced ldl-c in phase 3 coralreef lipids trial

 Enlicitide, designed to deliver antibody-like efficacy, has the potential to be the first approved oral PCSK9 inhibitor to lower LDL-C with a safety profile comparable to placebo

Enlicitide may help address unmet needs in ASCVD, a key driver of the ongoing cardiovascular (CV) epidemic

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of results from the pivotal Phase 3 CORALreef Lipids trial demonstrating that treatment with enlicitide decanoate, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, resulted in a statistically significant and clinically meaningful reduction in low-density lipoprotein cholesterol (LDL-C) of 55.8% (primary analysis; 95% CI: -60.9, -50.7; p<0.001) and of 59.7% in a post-hoc reanalysis (95% CI: -62.3, -57.1; p<0.001) compared to placebo at week 24. These late-breaking data will be presented for the first time today at the American Heart Association (AHA) Scientific Sessions 2025 (Abstract #4391578) and were selected for the Late-Breaking Science News Briefing.

https://finance.yahoo.com/news/merck-enlicitide-decanoate-investigational-oral-193000145.html

Lexicon Data on Efficacy of Sotagliflozin in Preserved Ejection Fraction Heart Failure

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.

https://www.stocktitan.net/news/LXRX/clinical-data-demonstrating-efficacy-of-sotagliflozin-in-preserved-kmg5ara3x48o.html