A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal … (NCT07428525) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function
United States36 participantsStarted 2025-03-14
Plain-language summary
The primary objective of the trial is to evaluate the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) dose in participants with mild, moderate, or severe hepatic impairment compared to participants with normal hepatic function.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Adults 18 to 75 years of age, male or female.
✓. Body mass index ≥ 22 kg/m\^2 at screening.
✓. For participants with normal hepatic function:
✓. For participants with hepatic impairment:
✓. Willing to use reliable contraception (if of childbearing potential) or practice abstinence through 16 weeks after dosing.
Exclusion criteria
✕. Any unstable medical condition (e.g., recent hospitalization or major surgery).
✕. History of acute or chronic pancreatitis within 1 year or lipase/amylase \> 2× ULN at screening.
✕. Endocrine disorder that can cause obesity (e.g., Cushing's syndrome).
✕. Significant cardiac conditions (e.g., clinically meaningful arrhythmias, 2nd/3rd-degree AV block, QT Interval Corrected Using Fridericia's Formula (QTcF) \>450 msec men / \>470 msec women for normal hepatic group; \> 490 msec men / \> 500 msec women for hepatic impairment).