Obesity, Overweight
Conditions
Keywords
Overweight, Obesity, Maridebart Cafraglutide, AMG 133, MariTide
Brief summary
The main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations in participants living with overweight or obesity.
Interventions
Maridebart cafraglutide will be administered SC.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, of any race, between 18 and 60 years of age, inclusive. a. Females must not be pregnant or lactating. 2. Body mass index between ≥25.0 and \<40.0 kg/m\^2.
Exclusion criteria
1. 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 study evaluation, procedures, or completion. 2. 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). 3. History or evidence of endocrine disorder (eg, Cushing's Syndrome) that can cause obesity. 4. 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. 5. Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ, within the last 5 years. 6. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2. 7. 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. 8. History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at screening or check-in. 9. History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related/similar compounds or their ingredients. 10. Estimated glomerular filtration rate ≤60 mL/min/1.73 m\^2, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation at screening or check-in. 11. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in. 12. Current use or prior use of any glucagon-like peptide-1 receptor (GLP-1R) agonist, or glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months prior to check-in. 13. 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. 14. 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. 15. Have previously completed or withdrawn from this study or any other study investigating maridebart cafraglutide or have previously received the investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide | Up to Day 120 |
| Area Under the Plasma Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide | Up to Day 120 |
| Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide | Up to Day 120 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-emergent Adverse Events | Up to Day 120 |
| Number of Participants with Serious Adverse Events | Up to Day 120 |
| Number of Participants with Anti-maridebart Cafraglutide Antibody Formation | Up to Day 120 |
Countries
United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed