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Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous (SC) 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
Lead sponsor
Asset
Maridebart cafraglutide / MariTide
Subcutaneous · GLP-1 agonist / GIP antagonist
Listed sites
4
Recruiting sites
—
Enrollment
348
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI 25-40
Primary endpoints
•AUC•Cmax of Maridebart Cafraglutide
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
6 endpointsArea Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide
Time frame:Up to Day 120
AUC₀–∞
concentration, descriptive
Area Under the Plasma Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide
Time frame:Up to Day 120
concentration, descriptive
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
Time frame:Up to Day 120
Cmax
concentration, descriptive
Number of Participants with Treatment-emergent Adverse Events
Time frame:Up to Day 120
Treatment-emergent AEs (any)
event count, event
Number of Participants with Serious Adverse Events
Time frame:Up to Day 120
Serious AEs (any)
event count, event
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
Time frame:Up to Day 120
Immunogenicity (ADA)
threshold achievement, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.