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
Amgen
Summary
Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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.…