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CompletedPhase 1

A Trial to Assess the Effect of Kidney Impairment on How AMG 133 is Absorbed, Broken Down, and Eliminated by the Body

A Phase 1, Open-label, Single-dose, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of AMG 133 in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

5

Recruiting sites

Enrollment

44

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criterion

BMI ≥22

Primary endpoints

Cmax of AMG 133AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)AUC From Time 0 Extrapolated to Infinity (AUCinf) of AMG 133

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 IDNCT07429045
Org study ID20230149

Timeline

Milestones

Study start2025-03-11actual
Primary completion2025-11-21actual
Study completion2025-11-21actual
Study first posted2026-02-24actual
Last update posted2026-02-24actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

All Participants in Groups 1 to 5

1. Male or female, of any race, between 18 and 75 years of age, inclusive.

a. Females must not be pregnant or lactating.

2. Body mass index > 22.0 kg/m2.

3. Eligible participants classified based on eGFR at screening and established need for renal replacement therapy as applicable.

Participants with Normal Renal Function

4. In good health as determined by no clinically significant findings from medical history, physical examination, vital signs measurements, 12-lead ECGs, and clinical laboratory evaluations.

Participants with Renal Impairment

5. Participants with renal impairment may have medical findings consistent with their renal dysfunction.

Exclusion criteria

All Participants in Groups 1 to 5

1. History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

2. History or evidence of endocrine disorder.

3. History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase/amylase (> 2 x ULN) at screening, or fasting serum triglyceride level of > 500 mg/dL at screening.

4. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.

5. History of hypersensitivity, intolerance, or allergy to AMG 133 or its ingredients or to related/similar compounds.

6. Active liver disease or hepatic dysfunction.

7. Clinically significant hyperkalemia.

8. Current use or prior use of any GLP-1R agonist, or GIPR agonist or antagonist within the past 3 months prior to check-in.

9. Participant has received a dose of an investigational drug within the past 30 days or 5 half-lives prior to AMG 133 dosing.

10. Have previously completed or withdrawn from this study or any other study investigating AMG 133 or have previously received the investigational product.

Participants with Normal Renal Function (Group 1)

11. History of active diabetes or evidence based on hemoglobin A1C of > 6.5% (> 48 mmol/mol).

12. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.

13. A history of renal disease or renal injury as indicated by medical history or an abnormal renal function profile.

Participants with Renal Impairment (Groups 2 to 5)

14. Participants who have a current, functioning organ transplant and/or are on immunosuppressants.

15. Participants on the national transplant list who anticipate receiving an organ transplant within 6 months of check-in.

16. History or current diagnosis of uncontrolled or significant cardiac disease indicative of a significant risk of safety for participation in the study.

17. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives before check-in.

18. History of poorly controlled diabetes or evidence based on hemoglobin A1C of > 11% (> 97 mmol/mol).

19. Active malignancy of any type.

20. A change in renal disease status within 30 days of screening.

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 Concentration (Cmax) of AMG 133

Time frame:Up to Day 120

Cmax

concentration, descriptive

Primary/protocol endpoint/low confidence

Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133

Time frame:Up to Day 120

concentration, descriptive

Primary/protocol endpoint

AUC From Time 0 Extrapolated to Infinity (AUCinf) of AMG 133

Time frame:Up to Day 120

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)

Time frame:Day 1 to Day 120

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants who Experienced Serious AEs (SAEs)

Time frame:Screening to Day 120 (up to 148 days)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants with Positive Anti-AMG 133 Antibody Formation

Time frame:Up to Day 120

Immunogenicity (ADA)

threshold achievement, 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.