Recruitment Complete
Sponsor ID
20250003
Effect of Maridebart Cafraglutide on the Heart’s Electrical Activity
Study Details
The main objective of this trial is to evaluate the effect of maridebart cafraglutide subcutaneously (SC) on the placebo-corrected, change from baseline in QT interval corrected for heart rate using Fridericia’s formula in participants living with overweight or obesity.
Protocol Summary
Primary Outcome Measures
Change from Baseline in QTcF for Maridebart Cafraglutide
Timeframe: Up to Day 171
Secondary Outcome Measures
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of Maridebart Cafraglutide
Timeframe: Up to Day 171
Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide
Timeframe: Up to Day 171
Change from Baseline in Heart Rate
Timeframe: Up to Day 171
Change from Baseline in PR Interval
Timeframe: Up to Day 171
Change from Baseline in QRS Duration
Timeframe: Up to Day 171
Categorical Outliers for QTcF
Timeframe: Up to Day 171
Categorical Outliers for HR
Timeframe: Up to Day 171
Categorical Outliers for PR
Timeframe: Up to Day 171
Categorical Outliers for QRS
Timeframe: Up to Day 171
Number of Participants with Treatment-emergent Changes in Electrocardiogram (ECG) Morphology
Timeframe: Up to Day 171
Change from Baseline in QTcF for Moxifloxacin
Timeframe: Up to Day 171
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Timeframe: Up to Day 232
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
Timeframe: Up to Day 232
Locations
Location
Fortrea Clinical Research Unit - Dallas
Dallas, TX, United States, 75247-4968
Status
Recruiting
Location
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, FL, United States, 32117-5116
Status
Recruiting