Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-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 or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).
Protocol Summary
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Timeframe: Baseline of parent trial (20210181) 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 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