Hepatic ImpairmentPhase 1NCT07428525
A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function
A Phase 1 study testing AMG 133 in people with Hepatic Impairment, run by Amgen at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- AMG 133
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Mar 2025to 26 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
- Diabetes mellitus not meeting glycemic cutoffs (hemoglobin A1C ≥ 6.5 % for normal hepatic group or > 11 % for hepatic impairment group).
- Active malignancy (within 18 months for hepatic impairment group; within 5 years for normal hepatic group).
- Hepatic encephalopathy Grade ≥ 3 (uncontrolled) or severe uncontrolled ascites.
- Organ transplant recipients or those on immunosuppressants.
- Participation in another clinical trial within 30 days or 5 drug half-lives (whichever is longer).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Clinical Pharmacology Of Miami, LLC
Miami, Florida, 33172
Panax Clinical Research
Miami Lakes, Florida, 33014-2811
Orlando Clinical Research Center
Orlando, Florida, 32809
The Texas Liver Institute, Inc.
San Antonio, Texas, 78215-2100
Pinnacle Clinical Research San Antonio
San Antonio, Texas, 78229-4801
About this study
Official title: 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.
- Conditions
- Hepatic Impairment
- Being tested
- AMG 133
- Keywords
- Liver disease
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 133Drug
Participants will receive AMG 133 SC.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: AMG 133 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of AMG 133
Measured: 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
Measured: Up to Day 120
AUC from Time Zero to Infinity (AUCinf) of AMG 133
Measured: Up to Day 120
Secondary outcomes (3)
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
Measured: Up to Day 120
Number of Participants Who Experience Serious Adverse Events (SAEs)
Measured: Up to Day 120
Number of Participants Who Develop Anti-AMG 133 Antibodies
Measured: Up to Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start14 Mar 2025
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428525
- Sponsor's protocol ID
- 20240024
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07428525
- Acronym / sponsor ID
- 20240024
- Conditions
- Hepatic Impairment
- Keywords
- Liver disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1, AMG 133: Normal Hepatic Function (No Impairment) | Experimental | Drug: AMG 133Participants with normal hepatic function will receive a single dose of AMG 133 SC on Day 1. |
| Group 2, AMG-133: Child-Pugh A (Mild Hepatic Impairment) | Experimental | Drug: AMG 133Participants with mild hepatic impairment will receive a single dose of AMG 133 SC on Day 1. |
| Group 3, AMG-133: Child-Pugh B (Moderate Hepatic Impairment) | Experimental | Drug: AMG 133Participants with moderate hepatic impairment will receive a single dose of AMG 133 SC on Day 1. |
| Group 4, AMG-133: Child-Pugh C (Severe Hepatic Impairment) | Experimental | Drug: AMG 133Participants with severe hepatic impairment will receive a single dose of AMG 133 SC on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 133Participants will receive AMG 133 SC. | Drug | 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) |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of AMG 133
Time frame: 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
AUC from Time Zero to Infinity (AUCinf) of AMG 133
Time frame: Up to Day 120
3 secondary outcomes
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 120
Number of Participants Who Experience Serious Adverse Events (SAEs)
Time frame: Up to Day 120
Number of Participants Who Develop Anti-AMG 133 Antibodies
Time frame: Up to Day 120
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 133 in people with Hepatic Impairment, run by Amgen at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of AMG 133 (time frame: Up to Day 120). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.