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

February 18, 2026 updated by: Amgen

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

The primary objective of this trial is to evaluate the pharmacokinetics of a single subcutaneous (SC) dose of AMG 133 in participants with various degrees of renal impairment compared to participants with normal renal function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Lake Forest, California, United States, 92630
        • Orange County Research Center
    • Florida
      • Miami, Florida, United States, 33147-4040
        • AdvancedPharma CR LLC
      • Miami Lakes, Florida, United States, 33016
        • Floridian Clinical Research, LLC
      • Orlando, Florida, United States, 32809-3017
        • Orlando Clinical Research Center
      • Orlando, Florida, United States, 32806-1133
        • Omega Research Group, LLC - Orlando

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Normal renal function
Participants with an estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min will receive a single dose of AMG 133 as a SC injection.
Participants will receive one dose of AMG 133 as a SC injection.
Other Names:
  • Maridebart cafraglutide
Experimental: Group 2: Mild renal impairment
Participants with an eGFR of 60 to < 90 mL/min will receive a single dose of AMG 133 as a SC injection.
Participants will receive one dose of AMG 133 as a SC injection.
Other Names:
  • Maridebart cafraglutide
Experimental: Group 3: Moderate renal impairment
Participants with an eGFR of 30 to < 60 mL/min will receive a single dose of AMG 133 as a SC injection.
Participants will receive one dose of AMG 133 as a SC injection.
Other Names:
  • Maridebart cafraglutide
Experimental: Group 4: Severe renal impairment and kidney failure not receiving hemodialysis
Participants with an eGFR of < 30 mL/min will receive a single dose of AMG 133 as a SC injection.
Participants will receive one dose of AMG 133 as a SC injection.
Other Names:
  • Maridebart cafraglutide
Experimental: Group 5: Kidney failure receiving hemodialysis
Participants with an eGFR of < 15 mL/min will receive a single dose of AMG 133 as a SC injection.
Participants will receive one dose of AMG 133 as a SC injection.
Other Names:
  • Maridebart cafraglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Concentration (Cmax) of AMG 133
Time Frame: Up to Day 120
Up to Day 120
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
Up to Day 120
AUC From Time 0 Extrapolated to Infinity (AUCinf) of AMG 133
Time Frame: Up to Day 120
Up to Day 120

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 to Day 120
Day 1 to Day 120
Number of Participants who Experienced Serious AEs (SAEs)
Time Frame: Screening to Day 120 (up to 148 days)
Screening to Day 120 (up to 148 days)
Number of Participants with Positive Anti-AMG 133 Antibody Formation
Time Frame: Up to Day 120
Up to Day 120

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2025

Primary Completion (Actual)

November 21, 2025

Study Completion (Actual)

November 21, 2025

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 20230149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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