Recruitment Complete
Sponsor ID
20250003

Effect of Maridebart Cafraglutide on the Heart’s Electrical Activity

Sponsor ID
20250003
Clinicaltrials.gov ID
NCT07229157
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
AMG 133
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
81
Additional Study Details

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
Status
Contact Us
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