GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

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

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

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Hepatic impairment

Key I/E criterion

•BMI ≥22

Primary endpoints

•Cmax of AMG 133•AUC

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07428525

Org study ID20240024

Timeline

Milestones

Study start2025-03-14actual

Study first posted2026-02-23actual

Primary completion2026-02-26actual

Study completion2026-02-26actual

Last update posted2026-03-11actual

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

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).

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of AMG 133

Time frame:Up to Day 120

Cmax

concentration, descriptive

Primary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

Time frame:Up to Day 120

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Up to Day 120

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants Who Experience Serious Adverse Events (SAEs)

Time frame:Up to Day 120

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants Who Develop Anti-AMG 133 Antibodies

Time frame:Up to Day 120

Immunogenicity (ADA)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.