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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
All Participants in Groups 1 to 5
Male or female, of any race, between 18 and 75 years of age, inclusive.
a. 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.
Exclusion Criteria
All Participants in Groups 1 to 5
- 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.
- 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.
- 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.
- Clinically significant hyperkalemia.
- 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)
- History of active diabetes or evidence based on hemoglobin A1C of > 6.5% (> 48 mmol/mol).
- Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
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)
- 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.
- History or current diagnosis of uncontrolled or significant cardiac disease indicative of a significant risk of safety for participation in the study.
- Use of any over-the-counter or prescription medications within 30 days or 5 half-lives before check-in.
- History of poorly controlled diabetes or evidence based on hemoglobin A1C of > 11% (> 97 mmol/mol).
- Active malignancy of any type.
- A change in renal disease status within 30 days of screening.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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:
|
|
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:
|
|
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:
|
|
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:
|
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Sponsor
Investigators
Investigators
- Study Director: MD, Amgen
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 20230149
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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