Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAmgen
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity
Body mass index ≤ 18.5 kilograms per meter square (kg/m²)
Participant has known sensitivity to any of the products or components to be administered during dosing
History of ischemic optic neuropathy
Trial design
Treatments tested in this trial
- Maridebart cafraglutide
- Placebo
Treatment groups
3,200 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov