Diabetes, obesity & metabolism · 2026
Effect of a Novel GLP-1 Analogue Ecnoglutide on the Pharmacokinetics of Rosuvastatin and Digoxin in Healthy Participants.
СтатьяКлиническое исследование I фазыНазвание и аннотация: Перевод пока не подготовлен
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Li Fengshan, Du Chunfeng, Yu Qin, Feng Shiyin, Cai Linrui, Chen Zhuo, Zou Qin, Guo Weiyi, Du Dan, Hu Feng, Liu Xiaohong, Huang Yalin, Shi Shuxia, Shi Wei, Guan Lei, Yang Liu, Zheng Qing, Li Yao, Liu Rui, Yang Ming
Аннотация
AIM: Evaluate ecnoglutide (XW003) effects on rosuvastatin and digoxin pharmacokinetics (PKs) in healthy adults.
METHODS: This was an open-label, single-sequence crossover Phase 1 study. Eligible participants received rosuvastatin (10 mg, single dose) and digoxin (0.25 mg, single dose) in two periods: Once before subcutaneous treatment with ecnoglutide and once during steady-state subcutaneous ecnoglutide (1.2 mg). Coadministration effect was assessed via PK parameters of both drugs.
RESULTS: A total of 28 volunteers received at least one dose of study drug. Co-administration of ecnoglutide did not affect rosuvastatin and digoxin to a clinically relevant degree. For the area under the concentration-time curve from time zero to infinity, the geometric mean (GM) ratio (with ecnoglutide vs. alone) [90% confidence interval (CI)] was 106% (94%, 120%) for rosuvastatin and 84% (76%, 94%) for digoxin. Additionally, the maximum plasma concentration (C max) of digoxin decreased from 1.39 to 1.31 ng/mL but remained within the therapeutic window. The most common adverse events (AEs) were weight loss and gastrointestinal AEs, which are pharmacologically associated with glucagon-like peptide-1 (GLP-1). No serious AEs were reported. Notably, ecnoglutide treatment led to substantial body weight reduction, with a mean decrease of 11.2% across the 14-week intervention.
CONCLUSION: Based on the PK and safety evaluations, ecnoglutide does not cause clinically significant PK interactions with rosuvastatin or digoxin. Consequently, no dose adjustments for rosuvastatin or digoxin are required when ecnoglutide is co-administered. However, close clinical and plasma monitoring is advised during the coadministration of digoxin, especially in patients with renal impairment.
METHODS: This was an open-label, single-sequence crossover Phase 1 study. Eligible participants received rosuvastatin (10 mg, single dose) and digoxin (0.25 mg, single dose) in two periods: Once before subcutaneous treatment with ecnoglutide and once during steady-state subcutaneous ecnoglutide (1.2 mg). Coadministration effect was assessed via PK parameters of both drugs.
RESULTS: A total of 28 volunteers received at least one dose of study drug. Co-administration of ecnoglutide did not affect rosuvastatin and digoxin to a clinically relevant degree. For the area under the concentration-time curve from time zero to infinity, the geometric mean (GM) ratio (with ecnoglutide vs. alone) [90% confidence interval (CI)] was 106% (94%, 120%) for rosuvastatin and 84% (76%, 94%) for digoxin. Additionally, the maximum plasma concentration (C max) of digoxin decreased from 1.39 to 1.31 ng/mL but remained within the therapeutic window. The most common adverse events (AEs) were weight loss and gastrointestinal AEs, which are pharmacologically associated with glucagon-like peptide-1 (GLP-1). No serious AEs were reported. Notably, ecnoglutide treatment led to substantial body weight reduction, with a mean decrease of 11.2% across the 14-week intervention.
CONCLUSION: Based on the PK and safety evaluations, ecnoglutide does not cause clinically significant PK interactions with rosuvastatin or digoxin. Consequently, no dose adjustments for rosuvastatin or digoxin are required when ecnoglutide is co-administered. However, close clinical and plasma monitoring is advised during the coadministration of digoxin, especially in patients with renal impairment.