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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3,200
Administered subcutaneously
Administered subcutaneously.
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Time frame: 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)
Time frame: Baseline of current trial up to 60 weeks
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 trial
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 trial
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 trial
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
Change from Baseline of the Parent Trial in Waist Circumference
Time frame: 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
Time frame: Baseline of parent trial to Week 48 of current trial
Percent Change from Baseline in Body Weight
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Pinnacle Research Group LLC
Anniston, Alabama, United States
RECRUITINGAlliance For Multispecialty Research - Daphne
Daphne, Alabama, United States
RECRUITINGAlliance for Multispecialty Research Mobile
Mobile, Alabama, United States
RECRUITINGArk Clinical Research- Tustin
Fountain Valley, California, United States
RECRUITINGLong Beach Clinical Trials Services Inc
Long Beach, California, United States
RECRUITINGArk Clinical Research- Long Beach
Long Beach, California, United States
RECRUITINGCatalina Research Institute
Montclair, California, United States
RECRUITINGArtemis Institute for Clinical Research
Riverside, California, United States
RECRUITINGApex Clinical Research
San Diego, California, United States
RECRUITINGArtemis Institute for Clinical Research
San Diego, California, United States
RECRUITING...and 77 more locations
Time frame: Baseline of current trial to Week 48
Percentage of Participants with No Body Weight Gain of >3% From Baseline
Time frame: Week 48 of current trial
Percentage of Participants with No Body Weight Gain of >5% From Baseline
Time frame: Week 48 of current trial
Percentage of Body Weight Reduction Maintained from the Parent Trial
Time frame: 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
Time frame: Baseline of parent trial to Week 48 of current trial