NCT07428525

A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function

A Phase 1, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics of AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	AMG 133	Participants will receive AMG 133 SC.

Timeline

• Start date: 2025-03-14
• Primary completion: 2026-02-26
• Completion: 2026-02-26
• First posted: 2026-02-23
• Last updated: 2026-03-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study