Current partner codePEPTIDESDE
NCT07428525·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

36

Locations

5

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

AMG 133

Participants will receive AMG 133 SC.

Timeline

From registration to results.

  1. First posted

    Feb 23, 2026

  2. Study start

    Mar 14, 2025

  3. Primary completion

    Feb 26, 2026

  4. Study completion

    Feb 26, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Mar 11, 2026

Outcomes

What the study measures.

Primary outcomes

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
Yes

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 locations

5 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Clinical Pharmacology Of Miami, LLC

Miami, Florida, United States

Panax Clinical Research

Miami Lakes, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

The Texas Liver Institute, Inc.

San Antonio, Texas, United States

Pinnacle Clinical Research San Antonio

San Antonio, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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