Recruiting
Sponsor ID
20250197

Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)

Sponsor ID
20250197
Clinicaltrials.gov ID
NCT07684235
EUCTIS ID
N/A
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 or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).

Additional Study Details

Phase
Phase 3
Product
AMG 133
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
3200
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

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 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

Locations

Location
Status
Contact Us
Location
Emeritus Research Camberwell
Camberwell, VIC, Australia, 3124
Status
Recruiting
Location
Canopy Clinical Sutherland
Miranda, NSW, Australia, 2228
Status
Recruiting
Location
Fusion Clinical Research
Norwood, SA, Australia, 5067
Status
Recruiting
Location
Canopy Clinical Wollongong
Wollongong, NSW, Australia, 2500
Status
Recruiting
Location
Canopy Clinical Altona North
Altona North, VIC, Australia, 3025
Status
Recruiting
Location
New Phase Research and Development
Knoxville, TN, United States, 37909
Status
Recruiting
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