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.

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 Have previously completed or withdrawn from this study or any other study investigating AMG 133 or have previously received the investigational product.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

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

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.

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.