MARITIME-PEN

Not yet recruitingPhase 3

Home Self-administration of Maridebart Cafraglutide With Autoinjector in Adults Living With Obesity or Overweight

A Phase 3 Multicenter, Open-label, Single-arm Trial Evaluating Home Self-Administration of Subcutaneous Maridebart Cafraglutide Via Autoinjector in Adult Participants Living With Obesity or Overweight Without Type 2 Diabetes Mellitus

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

Recruiting sites

Estimated enrollment

230

Study population

Obesity / overweight

Eligibility highlights

•BMI 27-30

Primary endpoints

•Percentage of Participants Who Successfully Self-inject a Full Dose Among Those•Percentage of Participants Who Successfully Self-inject a Full Dose Among All

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 IDNCT07871409

Org study ID20250207

Timeline

Milestones

Study first posted2026-10-13actual

Last update posted2026-10-13actual

Study start2026-10-28estimated

Primary completion2027-06-16estimated

Study completion2027-09-08estimated

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age99 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Body mass index (BMI) ≥ 30 kilograms per meter square (kg/m^2), or BMI ≥ 27 to < 30 kg/m^2 with one of the following:

-hypertension: treated, or with systolic blood pressure ≥ 130 millimeters of mercury (mmHg) or diastolic blood pressure ≥ 80 mmHg

-dyslipidemia: treated or previously diagnosed high cholesterol, high triglycerides, or low HDL cholesterol.

-history of obstructive sleep apnea

-history of cardiovascular disease

-history of fatty liver disease (including metabolic dysfunction-associated steatotic liver disease [MASLD] or metabolic dysfunction-associated steatohepatitis [MASH])

•At least 1 unsuccessful attempt at weight loss by diet and exercise.

•Contraception for females.

•Willingness to follow trial procedures for the duration of the trial.

Exclusion criteria

•Obesity induced by other endocrinologic disorders.

•Change in body weight > 5 kg within last 90 days.

•Previous or planned surgical, endoscopic, or device-based treatment for obesity.

•History of malignancy within the past 5 years.

•Type 1 or Type 2 diabetes mellitus.

•History of chronic pancreatitis or history of acute pancreatitis within last 180 days.

•Family or personal history of medullary thyroid cancer.

•Previous participation in a Maridebart Cafraglutide trial.

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.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight at Week 24

Time frame:Baseline and Week 24

percent change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Number of Participants Who Experience Device-related Adverse Events

Time frame:Up To 37 weeks

event count, event

Secondary/protocol endpoint

Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame:TEAEs: From baseline (Day 1) up to end of trial (approximately 37 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 41 weeks).

event count, event

Secondary/protocol endpoint

Plasma Concentration of Maridebart Cafraglutide at Week 24

Time frame:Week 24

concentration, descriptive

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration

Time frame:Weeks 12, 16, and 20

threshold achievement, improvement

Primary/protocol endpoint/low confidence

Percentage of Participants Who Successfully Self-inject a Full Dose Among All Participants Who Entered the Home Self-administration Phase at Each Scheduled Home Administration

Time frame:Weeks 12, 16, and 20

threshold achievement, improvement

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.