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Effect of Maridebart Cafraglutide on the Heart's Electrical Activity
A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled, Parallel Group Study With Nested Crossover Comparison to Assess the Effect of Maridebart Cafraglutide on QT/QTc Intervals in Participants Living With Overweight or Obesity
Lead sponsor
Asset
Maridebart cafraglutide / MariTide
Subcutaneous · GLP-1 agonist / GIP antagonist
Listed sites
2
Recruiting sites
—
Enrollment
81
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI 25-35
Primary endpoint
•QTcF for Maridebart Cafraglutide
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
To take part in the trial, participants must meet all of the following:
1. Provide signed and dated informed consent before any trial procedures.
2. Be able to understand the trial requirements, sign the consent form, and follow trial restrictions.
3. Male or female, of any race, between 18 and 60 years old (inclusive).
4. Body mass index (BMI) between 25.0 and 35.0 kg/m^2 (inclusive).
5. No major changes in diet or lifestyle in the past 3 months, based on self-report.
6. Stable body weight (less than 5 kg change) in the past 3 months, based on self-report.
7. Blood potassium, calcium, and magnesium within the normal range at screening and at check-in for the first treatment period.
8. 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
Participants will not be able to take part if they meet any of the following:
Medical Conditions
1. Any significant medical condition or abnormal test result that, in the opinion of the investigator, could pose a risk or interfere with trial participation.
2. History of diabetes (any type, except past gestational diabetes), or Haemoglobin A1c (HbA1c) ≥ 6.5% at screening.
3. History of pancreatitis within the past year, or high blood tests suggesting pancreatic problems (lipase/amylase > 2× normal, or fasting triglycerides > 500 mg/dL).
4. Liver enzymes (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) more than 2× the upper limit of normal.
5. Kidney function (estimated glomerular filtration rate [eGFR]) < 70 mL/min/1.73 m^2.
6. Cancer within the last 5 years (except treated nonmelanoma skin cancers or in situ cervical/breast lesions).
7. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.
8. Uncontrolled thyroid disease (abnormal thyroid-stimulating hormone [TSH] outside 0.4-6.0 mIU/L).
9. Contraindications to moxifloxacin, including history of tendon disorders with quinolone use.
10. History of gastrointestinal surgery or disease that may affect absorption of oral drugs (other than uncomplicated appendectomy or hernia repair).
11. Inability to swallow pills.
12. History of significant esophageal, stomach, or bowel disorders (eg, ulcers, bleeding, Crohn's disease, ulcerative colitis, irritable bowel syndrome, gastroparesis).
13. Current or recent suicidal thoughts (per Columbia Suicide Severity Rating Scale [C-SSRS]).
14. Lifetime history of suicide attempt or behavior.
15. Major depressive disorder within the past 2 years.
16. History of other serious psychiatric disorders (eg, schizophrenia, bipolar disorder).
17. High depression score (patient health questionnaire-9 [PHQ-9] ≥ 15).
18. History or current signs of heart disease (eg, heart attack, congenital defects, valve disease, angina, bypass or stent).
19. History of ischemic optic neuropathy (eye damage from poor blood flow).
20. Diagnosis of sleep apnea. Diagnostic Tests
21. Positive test for human immunodeficiency virus (HIV).
22. Positive test for hepatitis B or C (exceptions apply for prior vaccination or resolved infection).
23. Abnormal vital signs: average blood pressure > 140/90 mmHg or < 90/50 mmHg, or heart rate > 110 or < 40 bpm.
24. Abnormal ECG findings at screening or check-in, including:
25. Use of drugs that affect absorption, metabolism, or elimination within 30 days of dosing.
26. Use of drugs known to prolong QT/QTc within 30 days of dosing.
27. Use of prescription drugs (other than hormone replacement or contraception) within 14 days of dosing.
28. Use of long-acting/slow-release medicines still active within 14 days of dosing.
29. Use of non-prescription products (vitamins, supplements, herbal products) within 7 days of dosing.
30. Use of glucagon-like peptide-1 (GLP-1) or glucose-dependent insulinotropic polypeptide (GIP) receptor agonists/antagonists within 3 months of check-in.
Other Clinical Trial Experience
31. Participation in another investigational drug trial within 30 days or 5 drug half-lives (whichever is longer).
32. Previous exposure to maridebart cafraglutide in this or another trial. Lifestyle
33. Alcohol use > 21 units/week (men) or > 14 units/week (women).
34. Alcohol use within 48 hours before check-in.
35. Positive drug screen or alcohol test at screening or check-in.
36. History of alcohol or drug abuse within 1 year.
37. Use of tobacco/nicotine products within 3 months, or positive cotinine test.
38. Use of caffeine within 48 hours of screening or check-in.
39. Consumption of grapefruit, Seville orange, or related products within 7 days of check-in.
40. Consumption of poppy seed-containing foods within 7 days of check-in. Other
41. Receipt of blood products within 2 months before check-in.
42. Blood donation within 3 months; plasma donation within 2 weeks; platelet donation within 6 weeks.
43. Poor veins for blood draws.
44. Any other reason, in the opinion of the investigator, the participant should not take part.
Endpoints (14)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Cardiometabolic biomarkers
2 endpointsChange from Baseline in Heart Rate
Time frame:Up to Day 171
Heart rate, change
change from baseline, improvement
Categorical Outliers for HR
Time frame:Up to Day 171
Heart rate, change
descriptive
Safety / tolerability / PK
10 endpointsChange from Baseline in QTcF for Maridebart Cafraglutide
Time frame:Up to Day 171
change from baseline, descriptive
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of Maridebart Cafraglutide
Time frame:Up to Day 171
concentration, descriptive
Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide
Time frame:Up to Day 171
Cmax
concentration, descriptive
Change from Baseline in PR Interval
Time frame:Up to Day 171
change from baseline, descriptive
Categorical Outliers for QTcF
Time frame:Up to Day 171
categorical status, event
Categorical Outliers for QRS
Time frame:Up to Day 171
categorical status, event
Number of Participants with Treatment-emergent Changes in Electrocardiogram (ECG) Morphology
Time frame:Up to Day 171
descriptive
Change from Baseline in QTcF for Moxifloxacin
Time frame:Up to Day 171
change from baseline, descriptive
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Time frame:Up to Day 232
Treatment-emergent AEs (any)
event count, event
componentsTreatment-emergent AEs (any), Serious AEs (any)
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
Time frame:Up to Day 232
Immunogenicity (ADA)
descriptive
Other (unclassified)
2 endpointsChange from Baseline in QRS Duration
Time frame:Up to Day 171
change from baseline, descriptive
Categorical Outliers for PR
Time frame:Up to Day 171
categorical status, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.