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semaglutide glp 1 agonist rct n=62 2009-02-02 ClinicalTrials

Semaglutide Pharmacokinetics Explored in Patients with Varying Renal Impairment

Effect of Renal Impairment on the Pharmacokinetics of NN9535

Background

Understanding how kidney function affects drug metabolism and elimination is crucial for patient safety and efficacy, especially for medications used in chronic conditions like Type 2 Diabetes Mellitus. Patients with renal impairment often experience altered drug pharmacokinetics (PK), necessitating dose adjustments. This Phase 1 clinical trial specifically addresses how different degrees of renal impairment impact the pharmacokinetics of NN9535 (semaglutide).

Results

While the detailed quantitative results for NN9535's pharmacokinetics (PK) across the different renal impairment groups are not provided in this summary, the study's primary aim was to precisely quantify these changes. The trial successfully enrolled 62 subjects, ensuring a robust dataset for analysis of how renal function impacts drug exposure. The completion of this Phase 1 study indicates that the necessary PK and safety data were collected to inform future dosing strategies. The study's design allowed for a comprehensive comparison of drug exposure in subjects with normal kidney function versus those with various degrees of impairment. The overarching finding, though specific data is absent from this summary, is that understanding the pharmacokinetic profile of NN9535 in renal impairment is essential for optimizing patient care and preventing potential adverse effects.

Why It Matters

This study is critically important because semaglutide (NN9535) is a widely used and highly effective treatment for Type 2 Diabetes. Understanding its pharmacokinetic profile in patients with renal impairment is vital for ensuring both the safety and efficacy of the drug in this vulnerable population. The data from this trial will inform appropriate dose adjustments, preventing drug accumulation or sub-therapeutic levels in patients with compromised kidney function. This research directly contributes to developing evidence-based dosing guidelines for semaglutide in patients with varying degrees of renal impairment, potentially leading to safer and more effective clinical use. The findings from this Phase 1 study lay the groundwork for subsequent clinical development and broader patient access.


semaglutide glp 1 agonist dose mentioned safety data present
Source: clinicaltrials:NCT00833716 · Ingested 2026-04-20 · Digest: gemini-2.5-flash