Overweight and Obesity
Conditions
Keywords
Obesity, AMG 133, Maridebart cafraglutide, MariTide
Brief summary
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.
Interventions
DRUGAMG 133
Participants will receive one dose of AMG 133 as a SC injection.
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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 Have previously completed or withdrawn from this study or any other study investigating AMG 133 or have previously received the investigational product.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Concentration (Cmax) of AMG 133 | 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 | Up to Day 120 |
| AUC From Time 0 Extrapolated to Infinity (AUCinf) of AMG 133 | Up to Day 120 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs) | Day 1 to Day 120 |
| Number of Participants who Experienced Serious AEs (SAEs) | Screening to Day 120 (up to 148 days) |
| Number of Participants with Positive Anti-AMG 133 Antibody Formation | Up to Day 120 |
Countries
United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed