A Trial to Compare the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations
A Phase 1, Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Maridebart Cafraglutide (AMG 133) as Two Subcutaneous Presentations in Participants Living With Overweight or Obesity
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 Contact
Study Contact
- Name: Amgen Call Center
- Phone Number: 866-572-6436
- Email: medinfo@amgen.com
Study Locations
-
-
California
-
Anaheim, California, United States, 92801-2658
- Anaheim Clinical Trials
-
Los Alamitos, California, United States, 90720
- CenExel Collaborative Neuroscience Research, LLC Los Alamitos
-
-
Florida
-
Miami, Florida, United States, 33172-3161
- Clinical Pharmacology of Miami, LLC
-
-
Ohio
-
Columbus, Ohio, United States, 43212
- Ohio Clinical Trials, Inc.
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Male or female, of any race, between 18 and 60 years of age, inclusive.
a. Females must not be pregnant or lactating.
- Body mass index between 25.0 and <40.0 kg/m^2.
- Have a stable body weight (<5 kg self-reported change) within 3 months before screening, as assessed by the investigator (or designee) based on participant self-report.
Exclusion Criteria:
- History or evidence, at screening or check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion. Participants with clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) as assessed by the investigator (or designee) will be excluded.
- History of or active diabetes (regardless of type, with the exception of a history of gestational diabetes) or hemoglobin A1C ≥6.5% (≥48 mmol/mol).
- History or evidence of endocrine disorder (eg, Cushing's Syndrome) that can cause obesity.
- History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase/amylase (>2 x the upper limit of normal) at screening or a fasting serum triglyceride level of >500 mg/dL at screening.
- Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ, within the last 5 years.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
- History or current signs or symptoms of cardiovascular disease (aside from controlled hypertension and controlled dyslipidemia), including but not limited to myocardial infarction, congenital heart disease, valvular heart disease, coronary revascularization, or angina.
- History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at screening or check-in.
- History of hypersensitivity, intolerance, or allergy to AMG 133 or related/similar compounds or their ingredients.
- Estimated glomerular filtration rate ≤60 mL/min/1.73 m^2, as calculated by the Chronic Kidney Disease Epidemiology (CKD EPI) equation at screening or check-in.
- Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
- Current use or prior use of any glucagon-like peptide-1 receptor (GLP-1R) agonist, or gastric inhibitory polypeptide receptor (GIPR) agonist or antagonist within the past 3 months prior to check-in.
- Current or prior use of all herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to enrollment, unless deemed acceptable by the investigator (or designee) and in consultation with the medical monitor, as appropriate.
- Participant has received a dose of an investigational drug within the past 30 days or 5 half-lives, whichever is longer, prior to check-in.
- Have previously completed or withdrawn from this trial or any other trial investigating AMG 133 or have previously received the investigational product.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Maridebart Cafraglutide SC Presentation 1
Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 1.
|
Maridebart cafraglutide will be administered SC.
Other Names:
|
|
Active Comparator: Maridebart Cafraglutide SC Presentation 2
Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 2.
|
Maridebart cafraglutide will be administered SC.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of AMG 133
Time Frame: Up to Day 120
|
Up to Day 120
|
|
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) of AMG 133
Time Frame: Up to Day 120
|
Up to Day 120
|
|
AUC 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
|
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
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Day 1 to Day 120
|
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Number of Participants who Experienced Serious AEs (SAEs)
Time Frame: Screening to Day 120 (up to 148 days)
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Screening to Day 120 (up to 148 days)
|
|
Number of Participants with Positive Anti-AMG 133 Antibodies
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 (Estimated)
Primary Completion
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 20210268
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
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