Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-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 and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol.
Completed the Week 72 visit in Study 20210184.
Did not permanently discontinue the investigational product in the parent trial (20210184).
Randomized within 7 days of week 72 visit in the parent trial.
Disqualifiers
Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity.
Body mass index (BMI) ≤ 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
950 Participants
are divided into 9 treatment groups9
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: Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)Placebo comparator 1 intervention
Group H: Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)Experimental treatment 1 intervention
Group I: 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 (20210184)
Time frame
Baseline of parent trial (20210184) 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