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)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAmgen

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Body Mass Index (BMI) ≥ 25 at screening.

Weight loss of ≥ 10% on weekly GLP-1 RA.

Stable body weight.

Stable dose of GLP-1RA.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Maridebart Cafraglutide

    Drug

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: MariTide Arm 1Experimental treatment 1 intervention
Group B: MariTide Arm 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change from Baseline in Body Weight at Week 68

Time frame
Week 68

Secondary outcomes

1

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

Time frame
Week 68
2

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

Time frame
Week 68
3

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

Time frame
Week 68
4

Plasma Concentration of Maridebart Cafraglutide at Week 68

Time frame
Week 68

Other outcomes

Sponsors and contacts

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