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

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.

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.