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)

Conditions: Obesity or Overweight

Sex: All

Ages: 18 Years – 99 Years

Healthy volunteers: No

Phase: PHASE3

Enrollment: 300

Sponsor: Amgen

Location: Cahaba Research, Inc. Pelham Alabama

Summary

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

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07575399). StuddyBuddy aggregates publicly available trial information.