Effect of Maridebart Cafraglutide on the Heart's Electrical Activity (NCT07229157) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Effect of Maridebart Cafraglutide on the Heart's Electrical Activity
United States81 participantsStarted 2025-10-22
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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).
✓. Body mass index (BMI) between 25.0 and 35.0 kg/m\^2 (inclusive).
✓. No major changes in diet or lifestyle in the past 3 months, based on self-report.
✓. Stable body weight (less than 5 kg change) in the past 3 months, based on self-report.
✓. Blood potassium, calcium, and magnesium within the normal range at screening and at check-in for the first treatment period.
✓. Participants with controlled high blood pressure, cholesterol problems, or hypothyroidism on stable treatment for at least 3 months may be included (except for medicines known to affect heart rhythm or interact with moxifloxacin). Other mild, stable health conditions may be allowed with approval from the investigator and medical monitor.
Exclusion criteria
✕. Any significant medical condition or abnormal test result that, in the opinion of the investigator, could pose a risk or interfere with trial participation.
✕. History of diabetes (any type, except past gestational diabetes), or Haemoglobin A1c (HbA1c) ≥ 6.5% at screening.
✕
What they're measuring
1
Change from Baseline in QTcF for Maridebart Cafraglutide
. History of pancreatitis within the past year, or high blood tests suggesting pancreatic problems (lipase/amylase \> 2× normal, or fasting triglycerides \> 500 mg/dL).
✕. Liver enzymes (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]) more than 2× the upper limit of normal.