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

March 9, 2026 updated by: Amgen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33172
        • Clinical Pharmacology of Miami, LLC
      • Miami Lakes, Florida, United States, 33014-2811
        • Panax Clinical Research
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center
    • Texas
      • San Antonio, Texas, United States, 78215-2100
        • The Texas Liver Institute, Inc.
      • San Antonio, Texas, United States, 78229-4801
        • Pinnacle Clinical Research San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Adults 18 to 75 years of age, male or female.
  2. Body mass index ≥ 22 kg/m^2 at screening.

  3. 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.

  4. 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.
  5. Willing to use reliable contraception (if of childbearing potential) or practice abstinence through 16 weeks after dosing.

Exclusion Criteria:

  1. Any unstable medical condition (e.g., recent hospitalization or major surgery).
  2. History of acute or chronic pancreatitis within 1 year or lipase/amylase > 2× ULN at screening.
  3. Endocrine disorder that can cause obesity (e.g., Cushing's syndrome).
  4. 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).
  5. Estimated glomerular filtration rate < 60 mL/min/1.73 m^2 (normal/mild) or < 50 mL/min/1.73 m^2 (moderate/severe impairment).
  6. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
  7. Uncontrolled thyroid disease or clinically significant gastroparesis.
  8. Prior bariatric surgery within 6 months.
  9. Poor venous access.
  10. Positive Human Immunodeficiency Virus (HIV) test.
  11. Hypersensitivity to AMG 133 or its components.
  12. Current use of GLP-1 or GIP receptor agents within 3 months.
  13. Pregnancy or lactation, or unwillingness to follow contraception requirements.
  14. History of substance or alcohol abuse within 1 year or current alcohol intake > 21 units/week (men) or > 14 units/week (women).
  15. Positive test for hepatitis B surface antigen or active hepatitis C (with unstable disease).
  16. Diabetes mellitus not meeting glycemic cutoffs (hemoglobin A1C ≥ 6.5 % for normal hepatic group or > 11 % for hepatic impairment group).
  17. Active malignancy (within 18 months for hepatic impairment group; within 5 years for normal hepatic group).
  18. Hepatic encephalopathy Grade ≥ 3 (uncontrolled) or severe uncontrolled ascites.
  19. Organ transplant recipients or those on immunosuppressants.
  20. Participation in another clinical trial within 30 days or 5 drug half-lives (whichever is longer).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1, AMG 133: Normal Hepatic Function (No Impairment)
Participants with normal hepatic function will receive a single dose of AMG 133 SC on Day 1.
Drug: AMG 133
Participants will receive AMG 133 SC.
Experimental: Group 2, AMG-133: Child-Pugh A (Mild Hepatic Impairment)
Participants with mild hepatic impairment will receive a single dose of AMG 133 SC on Day 1.
Drug: AMG 133
Participants will receive AMG 133 SC.
Experimental: Group 3, AMG-133: Child-Pugh B (Moderate Hepatic Impairment)
Participants with moderate hepatic impairment will receive a single dose of AMG 133 SC on Day 1.
Drug: AMG 133
Participants will receive AMG 133 SC.
Experimental: Group 4, AMG-133: Child-Pugh C (Severe Hepatic Impairment)
Participants with severe hepatic impairment will receive a single dose of AMG 133 SC on Day 1.
Drug: AMG 133
Participants will receive AMG 133 SC.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum Observed Plasma Concentration (Cmax) of AMG 133
Time Frame: Up to Day 120
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
Time Frame: Up to Day 120
Up to Day 120
AUC from Time Zero to Infinity (AUCinf) of AMG 133
Time Frame: Up to Day 120
Up to Day 120

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to Day 120
Up to Day 120
Number of Participants Who Experience Serious Adverse Events (SAEs)
Time Frame: Up to Day 120
Up to Day 120
Number of Participants Who Develop Anti-AMG 133 Antibodies
Time Frame: Up to Day 120
Up to Day 120

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 26, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20240024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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