Effect of Maridebart Cafraglutide on the Heart's Electrical Activity

Not Applicable

Not yet recruiting

• Conditions: Overweight; Obesity
• Interventions: Drug: Maridebart Cafraglutide; Drug: Moxifloxacin; Drug: Placebo for Maridebart Cafraglutide; Drug: Placebo for Moxifloxacin

• Registration Number: NCT07229157
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-13
• Study First Submitted QC: 2025-11-13
• Last Update Submitted: 2025-11-13
• Study First Posted: 2025-11-14
• Last Update Posted: 2025-11-14
• Study Start: 2025-11-18
• Primary Completion: 2026-08-25
• Study Completion: 2026-08-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Maridebart Cafraglutide	In treatment period 1, participants will receive placebo for moxifloxacin. In treatment period 2, participants will receive maridebart cafraglutide. In treatment period 3, participants will receive placebo for moxifloxacin.
Group 2B	Placebo for Maridebart Cafraglutide	In treatment period 1, participants will receive placebo for moxifloxacin. In treatment period 2, participants will receive placebo for maridebart cafraglutide. In treatment period 3, participants will receive moxifloxacin.
Group 1	Placebo for Moxifloxacin	In treatment period 1, participants will receive placebo for moxifloxacin. In treatment period 2, participants will receive maridebart cafraglutide. In treatment period 3, participants will receive placebo for moxifloxacin.
Group 2A	Moxifloxacin	In treatment period 1, participants will receive moxifloxacin. In treatment period 2, participants will receive placebo for maridebart cafraglutide. In treatment period 3, participants will receive placebo for moxifloxacin.
Group 2A	Placebo for Maridebart Cafraglutide	In treatment period 1, participants will receive moxifloxacin. In treatment period 2, participants will receive placebo for maridebart cafraglutide. In treatment period 3, participants will receive placebo for moxifloxacin.
Group 2A	Placebo for Moxifloxacin	In treatment period 1, participants will receive moxifloxacin. In treatment period 2, participants will receive placebo for maridebart cafraglutide. In treatment period 3, participants will receive placebo for moxifloxacin.
Group 2B	Moxifloxacin	In treatment period 1, participants will receive placebo for moxifloxacin. In treatment period 2, participants will receive placebo for maridebart cafraglutide. In treatment period 3, participants will receive moxifloxacin.
Group 2B	Placebo for Moxifloxacin	In treatment period 1, participants will receive placebo for moxifloxacin. In treatment period 2, participants will receive placebo for maridebart cafraglutide. In treatment period 3, participants will receive moxifloxacin.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in QTcF for Maridebart Cafraglutide	Up to Day 171	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.

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of Maridebart Cafraglutide	Up to Day 171
Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide	Up to Day 171
Change from Baseline in Heart Rate	Up to Day 171	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.
Change from Baseline in PR Interval	Up to Day 171	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.
Change from Baseline in QRS Duration	Up to Day 171	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.
Categorical Outliers for QTcF	Up to Day 171
Categorical Outliers for HR	Up to Day 171
Categorical Outliers for PR	Up to Day 171
Categorical Outliers for QRS	Up to Day 171
Number of Participants with Treatment-emergent Changes in Electrocardiogram (ECG) Morphology	Up to Day 171
Change from Baseline in QTcF for Moxifloxacin	Up to Day 171	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.
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events	Up to Day 232
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation	Up to Day 232