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Active not recruitingPhase 1

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

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

4

Recruiting sites

Enrollment

349

actual

Study population

Obesity / overweight

Key I/E criterion

BMI 25-40

Primary endpoints

AUC From Time 0 to Infinity (AUCinf) of AMG 133AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)Cmax of AMG 133

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

NCT IDNCT07313761
Org study ID20210268

Timeline

Milestones

Study start2025-12-15actual
Study first posted2026-01-02actual
Last update posted2026-03-19actual
Primary completion2026-06-26estimated
Study completion2026-06-26estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

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.

3. 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

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 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.

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 AMG 133 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 (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 gastric inhibitory 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 trial or any other trial investigating AMG 133 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 endpoints
Primary/protocol endpoint

Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) of AMG 133

Time frame:Up to Day 120

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133

Time frame:Up to Day 120

concentration, descriptive

Primary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of AMG 133

Time frame:Up to Day 120

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)

Time frame:Day 1 to Day 120

Treatment-emergent AEs (any)

descriptive

Secondary/protocol endpoint

Number of Participants who Experienced Serious AEs (SAEs)

Time frame:Screening to Day 120 (up to 148 days)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants with Positive Anti-AMG 133 Antibodies

Time frame:Up to Day 120

Immunogenicity (ADA)

threshold achievement, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.