Recruiting NCT07575399
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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Maridebart Cafraglutide.
- Who it may be relevant to
- Registry conditions: Obesity or Overweight. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Puerto Rico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight.
Interventions
- Drug Maridebart Cafraglutide
Maridebart cafraglutide will be administered via subcutaneous (SC) injection.
Primary outcome measures
- Percent Change from Baseline in Body Weight at Week 68 [Time frame: Week 68]
Secondary outcome measures (5)
- Percent Change in Body Weight Prior to the Start of Weekly GLP-1RA at Week 68 [Time frame: Week 68]
- Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68 [Time frame: Week 68]
- Percent Maintenance of the Body Weight Reduction Achieved with Prior Weekly GLP-1RA Treatment at Week 68 [Time frame: Week 68]
- Plasma Concentration of Maridebart Cafraglutide at Week 68 [Time frame: Week 68]
- Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events [Time frame: Up to 84 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 43 centers
- Cahaba Research, Inc. — Pelham
- Arizona Clinical Trials — Chandler
- Epic Medical Research - Sun City — Sun City
- Desert Oasis Healthcare Medical Group — Palm Springs
- Inland Empire Liver Foundation — Rialto
- Peninsula Research Associates — Rolling Hills Estates
- Apex Clinical Research — San Diego
- Southern California Clinical Research — Santa Ana
- … and 35 more centers
Puerto Rico · 1 center
- Puerto Rico Medical Research Inc. — Ponce
Identifiers
NCT: NCT07575399 · 20250036