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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
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 133•AUC 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsMaximum Observed Concentration (Cmax) of AMG 133
Time frame:Up to Day 120
Cmax
concentration, descriptive
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
AUC From Time 0 Extrapolated to Infinity (AUCinf) of AMG 133
Time frame:Up to Day 120
AUC₀–∞
concentration, descriptive
Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
Time frame:Day 1 to Day 120
Treatment-emergent AEs (any)
event count, event
Number of Participants who Experienced Serious AEs (SAEs)
Time frame:Screening to Day 120 (up to 148 days)
Serious AEs (any)
event count, event
Number of Participants with Positive Anti-AMG 133 Antibody Formation
Time frame:Up to Day 120
Immunogenicity (ADA)
threshold achievement, event
Provenance
Sources
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.