Journal of clinical lipidology · 2026
NST-1024 for the treatment of very high triglycerides: A placebo-controlled, randomized, double-blind, 28-day clinical trial.
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Kastelein John Jp, Skjæret Tore, Jeannin Sophie, Beyusen Robin, Fraser David A, Maki Kevin C
Аннотация
BACKGROUND: NST-1024 is a semisynthetic eicosapentaenoic acid (EPA) derivative developed with the aim of achieving more potent triglyceride (TG) lowering effects as compared to unmodified EPA in conjunction with improved glycemic control.
OBJECTIVE: To evaluate the efficacy and safety of oral NST-1024 400 mg twice daily in patients with severe hypertriglyceridemia (sHTG) in a phase 2 proof-of-concept study.
METHODS: After a 2 to 4-week run-in period, men and women with TG levels ≥500 mg/dL and ≤ 2000 mg/dL were randomized to double-blind treatment with placebo or NST-1024 for 4 weeks. The primary endpoint was the % change from baseline in TGs at 4 weeks.
RESULTS: The evaluable population for efficacy analysis comprised 44 participants (NST-1024 [n = 23], placebo [n = 21]). At baseline, median TG (interquartile limits) levels were 730 (599-862) and 723 (611-863) mg/dL in the NST-1024 and placebo groups, respectively, and the median % changes after 4 weeks of treatment were -35.9% and -9.1%, respectively, a placebo-corrected change of -31.8% (P = .01). Treatment with NST-1024 significantly increased high-density lipoprotein cholesterol vs placebo (P = .04) with no significant difference between groups for non-high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, or apolipoprotein B. Fasting plasma glucose (least square [LS] mean difference -22 mg/dL, P = .01) and C-peptide (LS mean difference -398 pmol/L, P < .01) were both significantly reduced in NST-1024 treated patients vs placebo. NST-1024 was generally well tolerated.
CONCLUSION: Treatment with oral NST-1024 400 mg twice daily significantly reduced TGs in patients with sHTG in conjunction with improvements in glycemic control. This trial was registered at www.
CLINICALTRIALS: gov as NCT05889156.
OBJECTIVE: To evaluate the efficacy and safety of oral NST-1024 400 mg twice daily in patients with severe hypertriglyceridemia (sHTG) in a phase 2 proof-of-concept study.
METHODS: After a 2 to 4-week run-in period, men and women with TG levels ≥500 mg/dL and ≤ 2000 mg/dL were randomized to double-blind treatment with placebo or NST-1024 for 4 weeks. The primary endpoint was the % change from baseline in TGs at 4 weeks.
RESULTS: The evaluable population for efficacy analysis comprised 44 participants (NST-1024 [n = 23], placebo [n = 21]). At baseline, median TG (interquartile limits) levels were 730 (599-862) and 723 (611-863) mg/dL in the NST-1024 and placebo groups, respectively, and the median % changes after 4 weeks of treatment were -35.9% and -9.1%, respectively, a placebo-corrected change of -31.8% (P = .01). Treatment with NST-1024 significantly increased high-density lipoprotein cholesterol vs placebo (P = .04) with no significant difference between groups for non-high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, or apolipoprotein B. Fasting plasma glucose (least square [LS] mean difference -22 mg/dL, P = .01) and C-peptide (LS mean difference -398 pmol/L, P < .01) were both significantly reduced in NST-1024 treated patients vs placebo. NST-1024 was generally well tolerated.
CONCLUSION: Treatment with oral NST-1024 400 mg twice daily significantly reduced TGs in patients with sHTG in conjunction with improvements in glycemic control. This trial was registered at www.
CLINICALTRIALS: gov as NCT05889156.