Recruiting
Sponsor ID
20210182

Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)

Sponsor ID
20210182
Clinicaltrials.gov ID
NCT07684144
EUCTIS ID
2025-524788-19-00
EudraCT ID
N/A

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).

Additional Study Details

Phase
Phase 3
Product
Maridebart Cafraglutide
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
950
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations

Location
Status
Contact Us
Location
Optimus U Corporation
Miami, FL, United States, 33135
Status
Recruiting
Location
Velocity Clinical Research - Springdale
Cincinnati, OH, United States, 45246
Status
Recruiting
Location
Core Healthcare Group
Cerritos, CA, United States, 90703
Status
Recruiting
Location
West Clinical Research
Morehead City, NC, United States, 28557
Status
Recruiting
Location
Florida Institute for Clinical Research
Orlando, FL, United States, 32825
Status
Recruiting
Location
Premier Research
Trenton, NJ, United States, 08611
Status
Recruiting
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