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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Maridebart cafraglutide
DrugAdministered subcutaneously
Placebo
DrugAdministered subcutaneously.
Treatment groups
3,200 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: Maridebart Cafraglutide Low Dose Q4WExperimental treatment 1 intervention
Group B: Maridebart Cafraglutide Medium Dose Q4WExperimental treatment 1 intervention
Group C: Maridebart Cafraglutide Medium Dose Q8WExperimental treatment 1 intervention
Group D: Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)Placebo comparator 1 intervention
Group E: Maridebart Cafraglutide High Dose Q4WExperimental treatment 1 intervention
Group F: Maridebart Cafraglutide High Dose Q8WExperimental treatment 1 intervention
Group G: Maridebart Cafraglutide High Dose Q12WExperimental treatment 1 intervention
Group H: Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)Placebo comparator 1 intervention
Group I: Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)Experimental treatment 1 intervention
Group J: Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Time frame
Baseline of parent trial (20210181) to Week 48 of current trial2
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame
Baseline of current trial up to 60 weeksSecondary outcomes
1
Percentage of Participants Achieving ≥5% Reduction in Body Weight from Baseline of the Parent Trial
Time frame
Baseline of parent trial to Week 48 of current trial2
Percentage of Participants Achieving ≥10% Reduction in Body Weight from Baseline of the Parent Trial
Time frame
Baseline of parent trial to Week 48 of current trial3
Percentage of Participants Achieving ≥15% Reduction in Body Weight from Baseline of the Parent Trial
Time frame
Baseline of parent trial to Week 48 of current trial4
Percentage of Participants Achieving ≥20% Reduction in Body Weight from Baseline of the Parent Trial
Time frame
Baseline of parent trial to Week 48 of current trial Source ClinicalTrials.gov