Study Complete
Sponsor ID
20240024

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

Sponsor ID
20240024
Clinicaltrials.gov ID
NCT07428525
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 1
Product
Maridebart Cafraglutide
Type
Interventional
Masking
None (Open Label)
Enrollment
36
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of AMG 133

Timeframe: Up to Day 120

Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133

Timeframe: Up to Day 120

AUC from Time Zero to Infinity (AUCinf) of AMG 133

Timeframe: Up to Day 120

Secondary Outcome Measures

Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to Day 120

Number of Participants Who Experience Serious Adverse Events (SAEs)

Timeframe: Up to Day 120

Number of Participants Who Develop Anti-AMG 133 Antibodies

Timeframe: Up to Day 120

Locations

Location
Status
Contact Us
Location
The Texas Liver Institute, Inc.
San Antonio,, TX, United States, 78215-2100
Status
Recruiting
Location
Clinical Pharmacology Of Miami, LLC
Miami, FL, United States, 33172
Status
Completed
Location
Panax Clinical Research
Miami Lakes, FL, United States, 33014-2811
Status
Completed
Location
Pinnacle Clinical Research San Antonio
San Antonio, TX, United States, 78229-4801
Status
Completed
Location
Orlando Clinical Research Center
Orlando, FL, United States, 32809
Status
Completed