Not yet recruitingPhase 1

Comparing the Extent to Which Two Maridebart Cafraglutide Drug Products Are Made Available in the Body After a Single Subcutaneous Dose

A Phase 1, Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Two Maridebart Cafraglutide (AMG 133) Drug Products in Participants Living With Overweight or Obesity

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

Recruiting sites

Estimated enrollment

340

Study population

Obesity / overweight

Eligibility highlights

•BMI 25-40

Primary endpoints

•AUC From Time 0 Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide•AUC From Time 0 to the Time of the Last Quantifiable Concentration•Cmax of Maridebart Cafraglutide

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07832799

Org study ID20240301

Timeline

Milestones

Study first posted2026-09-22actual

Last update posted2026-09-22actual

Study start2026-10-12estimated

Primary completion2027-03-23estimated

Study completion2027-03-23estimated

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female participants, of any race, between 18 and 60 years of age (inclusive).

•Females must not be pregnant or lactating.

•Body mass index of ≥ 25.0 to < 40.0 kilograms per square meter (kg/m^2).

•Have a stable body weight within 3 months before screening.

Exclusion criteria

•History or evidence 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.

•History of or active diabetes (regardless of type, except history of gestational diabetes), or hemoglobin A1c ≥ 6.5%.

•History or evidence of endocrine disorder that can cause obesity.

•History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase or amylase (> 2 x upper limit of normal [ULN]) at screening or check-in, or fasting serum triglyceride level of > 500 milligrams per deciliter (mg/dL) at screening.

•Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ treated with curative intent, within the last 5 years.

•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2.

•History or current signs or symptoms of cardiovascular disease.

•History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related/similar compounds or its ingredients.

•Estimated glomerular filtration rate ≤ 60 mL/min/1.73 m^2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (2021) 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, glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months prior to check-in.

•Current or prior use of all herbal medicines, vitamins, and supplements consumed by the participant within the 30 days prior to check-in.

•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 study or any other study investigating maridebart cafraglutide or have previously received maridebart cafraglutide.

Endpoints (5)

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

5 endpoints

Primary/protocol endpoint

Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide

Time frame:Up to Day 120

concentration, descriptive

Primary/protocol endpoint

Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Maridebart Cafraglutide

Time frame:Up to Day 120

concentration, descriptive

Primary/protocol endpoint

Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide

Time frame:Up to Day 120

concentration, descriptive

Secondary/protocol endpoint

Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events

Time frame:Up to Day 120

event count, event

Secondary/protocol endpoint

Number of Participants With Anti-Maridebart Cafraglutide Antibodies

Time frame:Up to Day 120

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.