Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
Study Details
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).
Protocol Summary
Percent Change in Body Weight from Baseline of the Parent Trial (20210184)
Timeframe: Baseline of parent trial (20210184) to Week 48 of current trial
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: Baseline of current trial up to 60 weeks
Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline of the Parent Trial
Timeframe: Baseline of parent trial to Week 48 of current trial
Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline of the Parent Trial
Timeframe: Baseline of parent trial to Week 48 of current trial
Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline of the Parent Trial
Timeframe: Baseline of parent trial to Week 48 of current trial
Percentage of Participants Achieving ≥ 20% Reduction in Body Weight from Baseline of the Parent Trial
Timeframe: Baseline of parent trial to Week 48 of current trial
Change from Baseline of the Parent Trial in Hemoglobin A1c
Timeframe: Baseline of parent trial to Week 48 of current trial
Change from Baseline of the Parent Trial in Waist Circumference
Timeframe: Baseline of parent trial to Week 48 of current trial
Change from Baseline of the Parent Trial in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Timeframe: Baseline of parent trial to Week 48 of current trial
Percent Change from Baseline in Body Weight
Timeframe: Baseline of current trial to Week 48
Percentage of Participants with No Body Weight Gain of >3% From Baseline
Timeframe: Week 48 of current trial
Percentage of Participants with No Body Weight Gain of >5% From Baseline
Timeframe: Week 48 of current trial
Percentage of Body Weight Reduction Maintained from the Parent Trial
Timeframe: Baseline of parent trial to Week 48 of current trial
Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved in the Parent Trial
Timeframe: Baseline of parent trial to Week 48 of current trial
Change from Baseline in HbA1c
Timeframe: Week 48 of current trial