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Войти в исследования Diabetes, obesity & metabolism · 2026
Renal Impairment Does Not Affect Pharmacokinetics, Safety or Tolerability of Zenagamtide.
Клиническое исследование I фазыСтатьяНазвание и аннотация: Перевод в очереди
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Oldenburg Lykke Ida Kaas, Haugaard Sine Pfeiffer, Karlsson Tobias, Kegel-Hübner Victoria, Parwez Mahera, Wiingaard Christoffer, Flint Anne
Аннотация
AIMS: Zenagamtide is a novel, unimolecular glucagon-like peptide-1 and amylin receptor agonist in development for weight management and Type 2 diabetes. This study investigated the pharmacokinetic (PK) properties, safety and tolerability of zenagamtide in participants with various degrees of renal impairment versus participants with normal renal function.
MATERIALS AND METHODS: Adults with body mass index 20.0-39.9 kg/m2 were categorised based on baseline renal status using the CKD-EPI Collaboration creatinine equation (2021); normal function, mild impairment, moderate impairment, severe impairment and end-stage renal disease (ESRD). Participants received a single subcutaneous dose of zenagamtide 0.3 mg, followed by a 4-week follow-up period. The primary endpoint was area under the zenagamtide plasma concentration-time curve from time zero to infinity (AUC0-∞). Additional endpoints included maximum observed plasma zenagamtide concentration (C max) and number of treatment-emergent adverse events (TEAEs).
RESULTS: In total, 42 participants were included (n = 14, normal renal function group; n = 7 per renal impairment group). The range (geometric mean) of zenagamtide AUC0-∞ and C max across renal impairment groups were 520-715 h × nmol/L and 2.8-3.5 nmol versus 543 h × nmol/L and 3.2 nmol/L for the normal renal function group, respectively. Overall, TEAEs were reported in 30 (71.4%) participants. TEAEs were non-serious, none were severe and the majority were mild and most frequently gastrointestinal in nature.
CONCLUSIONS: Renal impairment did not appear to have a clinically relevant impact on the PK or safety profile of zenagamtide, suggesting that dose adjustment of zenagamtide is not warranted in this population.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT06559527.
MATERIALS AND METHODS: Adults with body mass index 20.0-39.9 kg/m2 were categorised based on baseline renal status using the CKD-EPI Collaboration creatinine equation (2021); normal function, mild impairment, moderate impairment, severe impairment and end-stage renal disease (ESRD). Participants received a single subcutaneous dose of zenagamtide 0.3 mg, followed by a 4-week follow-up period. The primary endpoint was area under the zenagamtide plasma concentration-time curve from time zero to infinity (AUC0-∞). Additional endpoints included maximum observed plasma zenagamtide concentration (C max) and number of treatment-emergent adverse events (TEAEs).
RESULTS: In total, 42 participants were included (n = 14, normal renal function group; n = 7 per renal impairment group). The range (geometric mean) of zenagamtide AUC0-∞ and C max across renal impairment groups were 520-715 h × nmol/L and 2.8-3.5 nmol versus 543 h × nmol/L and 3.2 nmol/L for the normal renal function group, respectively. Overall, TEAEs were reported in 30 (71.4%) participants. TEAEs were non-serious, none were severe and the majority were mild and most frequently gastrointestinal in nature.
CONCLUSIONS: Renal impairment did not appear to have a clinically relevant impact on the PK or safety profile of zenagamtide, suggesting that dose adjustment of zenagamtide is not warranted in this population.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT06559527.