MARITIME-SWITCH
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StatusAccepting Candidates
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Age18 Years - 99 Years
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SexesAll
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Healthy VolunteersNo
Objective
Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight.
Details
| Full study 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 |
| Protocol number | OCR50528 |
| ClinicalTrials.gov ID | NCT07575399 |
| Phase | Phase 3 |
Eligibility
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.
Lead researcher
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Diana Barb, MDEndocrinologist (Diabetes & Hormones Specialist)
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
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Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.