A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight
Study Details
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.
Protocol Summary
Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52
Timeframe: Baseline and Week 52
Percent Change from Baseline in Body Weight at Week 52
Timeframe: Baseline and Week 52
Number of Participants Achieving ≥ 30% Reduction from Baseline in Liver Fat Content (LFC) by MRI at Week 52
Timeframe: Baseline and Week 52
Percent Change from Baseline in Visceral Adipose Tissue (VAT) Volume by MRI at Week 52
Timeframe: Baseline and Week 52
Number of Participants Achieving < 5% LFC by MRI at Week 52
Timeframe: Week 52
Change from Baseline in LFC by MRI at Week 52
Timeframe: Baseline and Week 52
Percent Change from Baseline in LFC by MRI at Week 24
Timeframe: Baseline and Week 24
Change from Baseline in LFC by MRI at Week 24
Timeframe: Baseline and Week 24
Percent Change from Baseline in Thigh Muscle Volume by MRI at Week 24 and Week 52
Timeframe: Baseline, Week 24, and 52
Percent Change from Baseline in Thigh Muscle Fat Fraction by MRI at Week 24 and Week 52
Timeframe: Baseline, Week 24, and 52
Percent Change from Baseline in Thigh Intermuscular and Intramuscular Fat Volume by MRI at Week 24 and Week 52
Timeframe: Baseline, Week 24, and 52
Percent Change from Baseline in Abdominal Subcutaneous Adipose Tissue (ASAT) Volume by MRI at Week 52
Timeframe: Baseline and Week 52
Percent Change from Baseline in VAT Volume by MRI at Week 24
Timeframe: Baseline and Week 24
Percent Change from Baseline in ASAT Volume by MRI at Week 24
Timeframe: Baseline and Week 24
Change from Baseline in Waist Circumference at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in Waist-to-height Ratio at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in Aspartate Aminotransferase (AST) at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in Alanine Aminotransferase (ALT) at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in Gamma Glutamyl Transferase (GGT) at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in Fasting Glucose at Week 52
Timeframe: Baseline and Week 52
Percent Change from Baseline in Fasting Insulin at Week 52
Timeframe: Baseline and Week 52
Plasma Concentration of Maridebart Cafraglutide at Week 52
Timeframe: Week 52
Number of Participants Experiencing Treatment-emergent adverse events (TEAEs)
Timeframe: From first dose to end of trial (up to approximately 65 weeks)
Number of Participants Experiencing Serious AEs (SAEs)
Timeframe: From screening to end of trial (up to approximately 69 weeks)