AstraZeneca ((AZN)) announced an update on their ongoing clinical study.
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AstraZeneca is conducting a Phase I study titled ‘A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004.’ The study aims to evaluate the pharmacokinetics, safety, and tolerability of AZD5004 in participants with varying degrees of hepatic impairment compared to those with normal liver function. This research is significant as it could provide insights into the drug’s behavior in patients with liver conditions, potentially influencing treatment protocols.
The intervention being tested is AZD5004, a drug administered as a single oral dose under fasted conditions. The study seeks to understand how different levels of liver impairment affect the drug’s performance and safety profile.
The study design is interventional, with a non-randomized, parallel model. Participants are divided into four groups based on their liver function: mild, moderate, severe hepatic impairment, and normal function. The primary purpose is treatment-focused, and the study is open-label, meaning no masking is involved.
The study began on December 17, 2024, with the latest update submitted on September 4, 2025. These dates are crucial as they indicate the study’s progress and the timeline for potential results, which are yet to be submitted.
Market implications of this study could be significant for AstraZeneca’s stock performance, as positive outcomes may enhance the company’s portfolio in treating hepatic conditions. Investors will be keenly watching for results, especially in comparison to competitors in the pharmaceutical industry focusing on liver-related treatments.
The study is currently recruiting, with further details available on the ClinicalTrials portal.