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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
950
Administered subcutaneously.
Administered subcutaneously.
Percent Change in Body Weight from Baseline of the Parent Trial (20210184)
Time frame: 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)
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 Hemoglobin A1c
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
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Gilbert Center for Family Medicine
Gilbert, Arizona, United States
RECRUITINGSan Fernando Valley Health Institute
Canoga Park, California, United States
RECRUITINGCore Healthcare Group
Cerritos, California, United States
RECRUITINGVelocity Clinical Research Chula Vista
Chula Vista, California, United States
RECRUITINGEmpire Clinical Research
Pomona, California, United States
RECRUITINGOptimus U Corporation
Miami, Florida, United States
RECRUITINGSan Marcus Research Clinic Inc
Miami Lakes, Florida, United States
RECRUITINGIndago Research and Health Center
Miami Lakes, Florida, United States
RECRUITINGFlorida Institute for Clinical Research
Orlando, Florida, United States
RECRUITINGEncore Medical Research of Weston LLC
Weston, Florida, United States
RECRUITING...and 27 more locations
Time frame: Baseline of parent trial to Week 48 of current trial
Percent Change from Baseline in Body Weight
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
Change from Baseline in HbA1c
Time frame: Week 48 of current trial