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Not yet recruitingPhase 3

Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)

A Phase 3, Open-label Trial to Evaluate the Efficacy, Safety and Tolerability of Switching From the Glucagon-like Peptide-1 Receptor Agonists to Maridebart Cafraglutide in Adult Participants With Obesity or Overweight

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

0

Recruiting sites

Enrollment

300

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI ≥25

Primary endpoint

Body weight, % change

Identifiers

Registered as

NCT IDNCT07575399
Org study ID20250036

Timeline

Milestones

Study first posted2026-05-08actual
Last update posted2026-05-08actual
Study start2026-05-25estimated
Primary completion2028-01-03estimated
Study completion2028-02-28estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age99 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Body Mass Index (BMI) ≥ 25 at screening.
Weight loss of ≥ 10% on weekly GLP-1 RA.
Stable body weight.
Stable dose of GLP-1RA.
Stable gastrointestinal (GI) tolerability.
Contraception for females.
Willingness to follow trial procedures for the duration of the trial.

Exclusion criteria

Obesity induced by other endocrine disorders (ex: Cushing's syndrome).
Previous or planned surgical, endoscopic or device-based treatment for obesity.
History of malignancy.
Type 1/Type 2 diabetes mellitus (DM).
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

Weight & body composition
4
Safety / tolerability / PK
2

Weight & body composition

4 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Body Weight at Week 68

Time frame:Week 68

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change in Body Weight Prior to the Start of Weekly GLP-1RA at Week 68

Time frame:Week 68

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68

Time frame:Week 68

threshold achievement, improvement

Secondary/protocol endpoint

Percent Maintenance of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68

Time frame:Week 68

percent change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Plasma Concentration of Maridebart Cafraglutide at Week 68

Time frame:Week 68

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Up to 84 weeks

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

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.