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

Korábbi kezelés

• Current use or prior use of any GLP-1R agonist, or GIPR agonist or antagonist within the past 3 months prior to check-in.
• Participant has received a dose of an investigational drug within the past 30 days or 5 half-lives prior to AMG 133 dosing.
• Have previously completed or withdrawn from this study or any other study investigating AMG 133 or have previously received the investigational product.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)
• Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
• Participants who have a current, functioning organ transplant and/or are on immunosuppressants.
• Participants on the national transplant list who anticipate receiving an organ transplant within 6 months of check-in.
• Use of any over-the-counter or prescription medications within 30 days or 5 half-lives before check-in.

Más betegség

• 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.
• History or evidence of endocrine disorder.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
• History of hypersensitivity, intolerance, or allergy to AMG 133 or its ingredients or to related/similar compounds.
• Active liver disease or hepatic dysfunction.
• 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)
• History or current diagnosis of uncontrolled or significant cardiac disease indicative of a significant risk of safety for participation in the study.
• Active malignancy of any type.
• A change in renal disease status within 30 days of screening.

Laborértékek

• 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.
• History of active diabetes or evidence based on hemoglobin A1C of \> 6.5% (\> 48 mmol/mol).
• History of poorly controlled diabetes or evidence based on hemoglobin A1C of \> 11% (\> 97 mmol/mol).

Egyéb

• All Participants in Groups 1 to 5
• Clinically significant hyperkalemia.

• All Participants in Groups 1 to 5
• Male or female, of any race, between 18 and 75 years of age, inclusive.
  • Females must not be pregnant or lactating.
• Body mass index \> 22.0 kg/m2.
• Eligible participants classified based on eGFR at screening and established need for renal replacement therapy as applicable.
  • Participants with Normal Renal Function
• 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
• Participants with renal impairment may have medical findings consistent with their renal dysfunction.