RecruitingObesityOverweight

Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)

Eligible age

18–99 yrs

Accepts

All genders

Locations

27 states

Healthy volunteers

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About this study

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).

Sponsor: Amgen

You may qualify if…

✓ Signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
✓ Completed the parent trial (2010181)
✓ Completed week 72 visit in parent trial
✓ Did not permanently discontinue trial intervention in parent trial
✓ Randomized within 7 Days of week 72 visit in the parent trial
✓ Participants must use protocol-specified contraception during treatment, and for an additional 16 weeks after the last dose of trial intervention

You may not qualify if…

✕ Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity
✕ Body mass index ≤ 18.5 kilograms per meter square (kg/m\^2)
✕ Participant has known sensitivity to any of the products or components to be administered during dosing
✕ History of ischemic optic neuropathy
✕ Any malignancy diagnosed during parent trial (20210181) except for the following treated with curative intent: nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ.
✕ Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative\[s\]) history of medullary thyroid cancer.
✕ Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at week 72 visit from parent trial before randomization
✕ Any suicidal ideation of category 4 or 5 OR any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version at week 72 visit from parent trial before randomization.