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

NCT07428525 | Completed Phase 1 FDA Drug

• 1 other identifier: 20240024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Liver disease

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of AMG 133

  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

  Up to Day 120

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

  Up to Day 120

Secondary Outcomes (3)

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

  Up to Day 120

• Number of Participants Who Experience Serious Adverse Events (SAEs)

  Up to Day 120

• Number of Participants Who Develop Anti-AMG 133 Antibodies

  Up to Day 120

Study Arms (4)

Group 1, AMG 133: Normal Hepatic Function (No Impairment)

EXPERIMENTAL

Participants with normal hepatic function will receive a single dose of AMG 133 SC on Day 1.

Drug: AMG 133

Group 2, AMG-133: Child-Pugh A (Mild Hepatic Impairment)

EXPERIMENTAL

Participants with mild hepatic impairment will receive a single dose of AMG 133 SC on Day 1.

Drug: AMG 133

Group 3, AMG-133: Child-Pugh B (Moderate Hepatic Impairment)

EXPERIMENTAL

Participants with moderate hepatic impairment will receive a single dose of AMG 133 SC on Day 1.

Drug: AMG 133

Group 4, AMG-133: Child-Pugh C (Severe Hepatic Impairment)

EXPERIMENTAL

Participants with severe hepatic impairment will receive a single dose of AMG 133 SC on Day 1.

Drug: AMG 133

Interventions

AMG 133 DRUG

Participants will receive AMG 133 SC.

Group 1, AMG 133: Normal Hepatic Function (No Impairment); Group 2, AMG-133: Child-Pugh A (Mild Hepatic Impairment); Group 3, AMG-133: Child-Pugh B (Moderate Hepatic Impairment); Group 4, AMG-133: Child-Pugh C (Severe Hepatic Impairment)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• In good health with no clinically significant findings from medical history, physical exam, electrocardiogram (ECG), vital signs, or laboratory tests.
• Systolic blood pressure (BP) 90-150 mmHg and diastolic BP 50-100 mmHg; pulse 40-110 bpm.
• Stable body weight (\< 5 kg change) and no recent dietary modifications within 3 months.
• For participants with hepatic impairment:
• Documented Child-Pugh Class A (mild), B (moderate), or C (severe) hepatic impairment.
• Clinically stable chronic liver disease (e.g., cirrhosis, hepatitis B, alcoholic liver disease, or stable hepatitis C).
• Systolic BP ≤ 170 mmHg and diastolic BP ≤ 100 mmHg.
• Willing to use reliable contraception (if of childbearing potential) or practice abstinence through 16 weeks after dosing.

You may not qualify if:

• 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).
• Estimated glomerular filtration rate \< 60 mL/min/1.73 m\^2 (normal/mild) or \< 50 mL/min/1.73 m\^2 (moderate/severe impairment).
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
• Uncontrolled thyroid disease or clinically significant gastroparesis.
• Prior bariatric surgery within 6 months.
• Poor venous access.
• Positive Human Immunodeficiency Virus (HIV) test.
• Hypersensitivity to AMG 133 or its components.
• Current use of GLP-1 or GIP receptor agents within 3 months.
• Pregnancy or lactation, or unwillingness to follow contraception requirements.
• History of substance or alcohol abuse within 1 year or current alcohol intake \> 21 units/week (men) or \> 14 units/week (women).
• Positive test for hepatitis B surface antigen or active hepatitis C (with unstable disease).

Sponsors & Collaborators

• Amgen: lead

Study Sites (5)

Clinical Pharmacology Of Miami, LLC

Miami, Florida, 33172, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014-2811, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

The Texas Liver Institute, Inc.

San Antonio, Texas, 78215-2100, United States

Location

Pinnacle Clinical Research San Antonio

San Antonio, Texas, 78229-4801, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 23, 2026
• Study Start: March 14, 2025
• Primary Completion: February 26, 2026
• Study Completion: February 26, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (5)