Effect of Maridebart Cafraglutide on the Heart's Electrical Activity
NCT ID: NCT07229157
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
82 participants
INTERVENTIONAL
2025-10-22
2026-08-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
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.
Maridebart Cafraglutide
Participants will receive maridebart cafraglutide SC.
Placebo for Moxifloxacin
Participants will receive placebo for moxifloxacin orally.
Group 2A
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.
Moxifloxacin
Participants will receive moxifloxacin orally.
Placebo for Maridebart Cafraglutide
Participants will receive placebo for maridebart cafraglutide SC.
Placebo for Moxifloxacin
Participants will receive placebo for moxifloxacin orally.
Group 2B
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.
Moxifloxacin
Participants will receive moxifloxacin orally.
Placebo for Maridebart Cafraglutide
Participants will receive placebo for maridebart cafraglutide SC.
Placebo for Moxifloxacin
Participants will receive placebo for moxifloxacin orally.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Maridebart Cafraglutide
Participants will receive maridebart cafraglutide SC.
Moxifloxacin
Participants will receive moxifloxacin orally.
Placebo for Maridebart Cafraglutide
Participants will receive placebo for maridebart cafraglutide SC.
Placebo for Moxifloxacin
Participants will receive placebo for moxifloxacin orally.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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).
* Females must not be pregnant or breastfeeding.
* Males and females who could become pregnant must agree to use effective birth control as specified in the protocol.
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
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:
* QTcF \> 450 ms (males) or \> 470 ms (females).
* QRS \> 120 ms, PR \> 220 ms, AV block (2nd or 3rd degree).
* Findings that make QTc measurement unreliable.
* Risk factors for dangerous arrhythmias (eg, heart failure, low potassium, long QT syndrome).
* Clinically significant arrhythmias. Medications
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.
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, United States
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20250003
Identifier Type: -
Identifier Source: org_study_id