New drug tested in patients with liver disease
NCT ID NCT07428525
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at how the body processes a single dose of the drug AMG 133 in people with different levels of liver impairment compared to those with healthy livers. Thirty-six adults took part, and researchers measured drug levels in the blood and checked for side effects. The goal is to guide safe dosing for future studies in patients with liver disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AMG 133
- What this could lead to
- If successful, this study will help doctors understand how to dose AMG 133 safely in patients with liver disease.
- What could go wrong
- This is an early, small study (36 people) focused on drug levels, not on treating a disease. Results may not apply to broader populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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36 people
The number who actually took part.
- Started
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Mar 2025
- Finished
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Feb 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Clinical Pharmacology Of Miami, LLC
Miami, Florida, 33172, United States
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Orlando Clinical Research Center
Orlando, Florida, 32809, United States
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Panax Clinical Research
Miami Lakes, Florida, 33014-2811, United States
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Pinnacle Clinical Research San Antonio
San Antonio, Texas, 78229-4801, United States
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The Texas Liver Institute, Inc.
San Antonio, Texas, 78215-2100, United States
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Other studies related to the condition(s) this trial covers.
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