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Effect of Maridebart Cafraglutide on the Heart's Electrical Activity

Plain-language guide to NCT07229157: phase 1 randomized trial of MariTide (Maridebart Cafraglutide), 81 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07229157
Phase
phase 1
Status
completed
Start
2025-10-22
Completion (planned or actual)
2026-08-27
Participants
81 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Overweight; Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1) is built around MariTide (Maridebart Cafraglutide).

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.

It had three arms (groups): Group 1 (experimental), Group 2A (experimental) and Group 2B (experimental).

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.

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.

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.

The registry classes the interventions as drug.

Who Took Part

The registry lists 81 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Provide signed and dated informed consent before any trial procedures. Be able to understand the trial requirements, sign the consent form, and follow trial restrictions. Male or female, of any race, between 18 and 60 years old (inclusive). Females must not be pregnant or breastfeeding. Body mass index (BMI) between 25.0 and 35.0 kg/m\^2 (inclusive).

The full record lists 10 inclusion and 49 exclusion criteria; among the exclusions: liver enzymes (alanine aminotransferase \[alt\] or aspartate aminotransferase \[ast\]) more than 2× the upper limit of normal; cancer within the last 5 years (except treated nonmelanoma skin cancers or in situ cervical/breast lesions); personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Random assignment meant chance, not the researchers, decided who got MariTide (Maridebart Cafraglutide) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both MariTide (Maridebart Cafraglutide) and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on MariTide (Maridebart Cafraglutide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2025-10-22 with completion listed for 2026-08-27.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Change from Baseline in QTcF for Maridebart Cafraglutide (time frame: Up to Day 171).

It also tracked 13 secondary outcomes, for example Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide, Change from Baseline in Heart Rate, Change from Baseline in PR Interval, Change from Baseline in QRS Duration, Categorical Outliers for QTcF and Categorical Outliers for HR.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of MariTide (Maridebart Cafraglutide) in 81 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the MariTide (Maridebart Cafraglutide) compound page, all human trials.

Our Notes on the Compound

MariTide (Maridebart Cafraglutide): Amgen's once-monthly antibody-peptide conjugate that blocks GIP receptors and activates GLP-1 receptors, in phase 3 obesity trials. News and evidence page only.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.