Phase 1 PK Study of HRS9531 Injection in Mild to Normal Hepatic Function
Summary
The NIH ClinicalTrials.gov registry has published a Phase 1 clinical study (NCT07540754) to evaluate the pharmacokinetics of HRS9531 Injection in participants with mild and moderate hepatic impairment compared to participants with normal hepatic function. The study will also assess safety. Participants have conditions of Diabetes Mellitus and Weight Loss. The study was registered with an anticipated date of April 20, 2026.
What changed
This entry registers a new Phase 1 clinical trial evaluating the pharmacokinetics of HRS9531 Injection across hepatic function categories. The study design compares participants with mild and moderate hepatic impairment against those with normal hepatic function, with safety as a secondary endpoint.
Pharmaceutical companies and clinical trial sponsors conducting early-phase research in metabolic indications should note this study's inclusion criteria and PK endpoints as potentially representative of FDA expectations for hepatic impairment assessments in drug development.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function
Phase 1 NCT07540754 Kind: PHASE1 Apr 20, 2026
Abstract
This is a Phase I clinical study to compare the pharmacokinetics (PK) of HRS9531 Injection in participants with mild/moderate hepatic impairment and participants with normal hepatic function, and to evaluate the safety of HRS9531 Injection in these participants.
Conditions: Diabetes Mellitus, Weight Loss
Interventions: HRS9531 Injection
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