Renal Impairment Does Not Affect Pharmacokinetics, Safety or Tolerability of Zenagamtide.
Lykke Ida Kaas Oldenburg, Sine Pfeiffer Haugaard, Tobias Karlsson et al.
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In 30 seconds
This Phase I clinical trial evaluated the pharmacokinetics, safety, and tolerability of zenagamtide in adults with varying degrees of renal impairment compared to those with normal renal function. The study found that renal impairment did not significantly affect the pharmacokinetic properties, with AUC 0-∞ ranging from 520-715 h×nmol/L across groups. Overall, treatment-emergent adverse events were mild and non-serious.
Key findings
- AUC 0-∞ for zenagamtide ranged from 520-715 h×nmol/L across renal impairment groups.
- C max values ranged from 2.8-3.5 nmol/L in renal impairment groups compared to 3.2 nmol/L in normal function.
- 71.4% of participants reported treatment-emergent adverse events, primarily mild gastrointestinal issues.
Why it matters
Understanding the pharmacokinetics and safety of medications in patients with renal impairment is crucial for effective management of conditions like Type 2 diabetes, ensuring safe prescribing practices.