The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
409
Solution for subcutaneous injection.
Solution for subcutaneous injection.
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
Time frame: Baseline to Week 24
Percent Change From Baseline to Week 24 in Body Weight
Time frame: Baseline to Week 24
Number of Participants Achieving HbA1c < 7.0% at Week 24
Time frame: Week 24
Number of Participants Achieving HbA1c ≤ 6.5% at Week 24
Time frame: Week 24
Number of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 24
Time frame: Week 24
Number of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 24
Time frame: Week 24
Change From Baseline to Week 24 in Fasting Glucose
Time frame: Baseline to Week 24
Percent Change From Baseline to Week 24 in Total Cholesterol
Time frame: Baseline to Week 24
Percent Change From Baseline to Week 24 in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline to Week 24
Percent Change From Baseline to Week 24 in High-density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline to Week 24
Percent Change From Baseline to Week 24 in Non-high Density Lipoprotein Cholesterol (non-HDL-C)
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Accel Research Site - Birmingham Clinical Research Unit
Birmingham, Alabama, United States
Anaheim Clinical Trials
Anaheim, California, United States
Hope Clinical Research LLC
Canoga Park, California, United States
Orange County Research Center
Lake Forest, California, United States
San Jose Clinical Trials
San Jose, California, United States
Northeast Research Institute - Neri
Fleming Island, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Florida Institute for Clinical Research
Orlando, Florida, United States
Conquest Research - Winter Park
Winter Park, Florida, United States
Accel Research Site - Neurostudies
Decatur, Georgia, United States
...and 86 more locations
Time frame: Baseline to Week 24
Percent Change From Baseline to Week 24 in Very-low-density Lipoprotein Cholesterol (VLDL-C)
Time frame: Baseline to Week 24
Percent Change From Baseline to Week 24 in Triglycerides
Time frame: Baseline to Week 24
Percent Change From Baseline to Week 24 in Free Fatty Acids (FFA)
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in Systolic Blood Pressure
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in Diastolic Blood Pressure
Time frame: Baseline and Week 24
Change from Baseline to Week 24 in High-sensitivity C-reactive Protein
Time frame: Baseline and Week 24
Pre-dose Plasma Concentration of Maridebart Cafraglutide at Week 20
Time frame: Week 20
Maximum Observed Plasma Concentration of Maridebart Cafraglutide at Week 20
Time frame: Week 20
Number of Participants with Treatment Emergent Adverse Events
Time frame: Up to 24 Weeks
Number of Participants with Serious Adverse Events
Time frame: Up to 24 Weeks
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
Time frame: Up to Week 24