The main objective of this trial will be to determine whether maridebart cafraglutide is superior to placebo on reduction in liver fat content and body weight in participants living with obesity or overweight and elevated liver fat content, when administered in conjunction with reduced-calorie diet and increased physical activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Maridebart cafraglutide will be administered as a SC injection.
Placebo will be administered as a SC injection.
Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52
Time frame: Baseline and Week 52
Percent Change from Baseline in Body Weight at Week 52
Time frame: Baseline and Week 52
Number of Participants Achieving ≥ 30% Reduction from Baseline in Liver Fat Content (LFC) by MRI at Week 52
Time frame: Baseline and Week 52
Percent Change from Baseline in Visceral Adipose Tissue (VAT) Volume by MRI at Week 52
Time frame: Baseline and Week 52
Number of Participants Achieving < 5% LFC by MRI at Week 52
Time frame: Week 52
Change from Baseline in LFC by MRI at Week 52
Time frame: Baseline and Week 52
Percent Change from Baseline in LFC by MRI at Week 24
Time frame: Baseline and Week 24
Change from Baseline in LFC by MRI at Week 24
Time frame: Baseline and Week 24
Percent Change from Baseline in Thigh Muscle Volume by MRI at Week 24 and Week 52
Time frame: Baseline, Week 24, and 52
Percent Change from Baseline in Thigh Muscle Fat Fraction by MRI at Week 24 and Week 52
Time frame: Baseline, Week 24, and 52
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Phoenix, Arizona, United States
RECRUITINGDel Sol Research Management
Tucson, Arizona, United States
RECRUITINGSan Fernando Valley Health Institute
Canoga Park, California, United States
RECRUITINGGastroenterology and Liver Institute
Escondido, California, United States
RECRUITINGInland Empire Liver Foundation
Rialto, California, United States
RECRUITINGApex Clinical Research
San Diego, California, United States
RECRUITINGUniversity of Florida College of Medicine-Jacksonville
Gainesville, Florida, United States
RECRUITINGFloridian Clinical Research LLC
Miami Lakes, Florida, United States
RECRUITINGIndago Research and Health Center
Miami Lakes, Florida, United States
RECRUITING...and 13 more locations
Percent Change from Baseline in Thigh Intermuscular and Intramuscular Fat Volume by MRI at Week 24 and Week 52
Time frame: Baseline, Week 24, and 52
Percent Change from Baseline in Abdominal Subcutaneous Adipose Tissue (ASAT) Volume by MRI at Week 52
Time frame: Baseline and Week 52
Percent Change from Baseline in VAT Volume by MRI at Week 24
Time frame: Baseline and Week 24
Percent Change from Baseline in ASAT Volume by MRI at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Waist Circumference at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Waist-to-height Ratio at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Aspartate Aminotransferase (AST) at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Alanine Aminotransferase (ALT) at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Gamma Glutamyl Transferase (GGT) at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Fasting Glucose at Week 52
Time frame: Baseline and Week 52
Percent Change from Baseline in Fasting Insulin at Week 52
Time frame: Baseline and Week 52
Plasma Concentration of Maridebart Cafraglutide at Week 52
Time frame: Week 52
Number of Participants Experiencing Treatment-emergent adverse events (TEAEs)
Time frame: From first dose to end of trial (up to approximately 65 weeks)
Number of Participants Experiencing Serious AEs (SAEs)
Time frame: From screening to end of trial (up to approximately 69 weeks)