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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
81
Participants will receive maridebart cafraglutide SC.
Participants will receive moxifloxacin orally.
Participants will receive placebo for maridebart cafraglutide SC.
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, United States
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, United States
Change from Baseline in QTcF for Maridebart Cafraglutide
Change from baseline in QTcF for maridebart cafraglutide will be the dependent variable for calculation of model-derived placebo-corrected, change from baseline in QTcF after maridebart cafraglutide dosing.
Time frame: Up to Day 171
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of Maridebart Cafraglutide
Time frame: Up to Day 171
Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide
Time frame: Up to Day 171
Change from Baseline in Heart Rate
Change from baseline in heart rate will be used as the dependent variable for calculation of model-derived placebo-corrected, change from baseline in HR for the by-time point analysis.
Time frame: Up to Day 171
Change from Baseline in PR Interval
Change from baseline in PR Interval will be used as the dependent variable for calculation of model-derived placebo-corrected, change from baseline in PR for the by-time point analysis.
Time frame: Up to Day 171
Change from Baseline in QRS Duration
Change from baseline in QRS Duration will be used as the dependent variable for calculation of model-derived placebo-corrected, change from baseline in QRS for the by-time point analysis.
Time frame: Up to Day 171
Categorical Outliers for QTcF
Time frame: Up to Day 171
Categorical Outliers for HR
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Participants will receive placebo for moxifloxacin orally.
Time frame: Up to Day 171
Categorical Outliers for PR
Time frame: Up to Day 171
Categorical Outliers for QRS
Time frame: Up to Day 171
Number of Participants with Treatment-emergent Changes in Electrocardiogram (ECG) Morphology
Time frame: Up to Day 171
Change from Baseline in QTcF for Moxifloxacin
Change from baseline in QTcF for moxifloxacin will be used as the dependent variable for calculation of model-derived placebo-corrected, change from baseline in QTcF after moxifloxacin dosing for both the assay sensitivity and by-time point analysis.
Time frame: Up to Day 171
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Time frame: Up to Day 232
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
Time frame: Up to Day 232