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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07575399

Enrollment

300

Registered

2026-05-08

Start date

2026-05-25

Completion date

2028-02-28

Last updated

2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity or Overweight

Brief summary

Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight.

Interventions

DRUGMaridebart Cafraglutide

Maridebart cafraglutide will be administered via subcutaneous (SC) injection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Percent Change from Baseline in Body Weight at Week 68	Week 68

Secondary

Measure	Time frame
Percent Change in Body Weight Prior to the Start of Weekly GLP-1RA at Week 68	Week 68
Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68	Week 68
Percent Maintenance of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68	Week 68
Plasma Concentration of Maridebart Cafraglutide at Week 68	Week 68
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events	Up to 84 weeks

Contacts

CONTACTAmgen Call Center

medinfo@amgen.com866-572-6436

STUDY_DIRECTORMD

Amgen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026