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Active not recruitingPhase 1

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

Amgen

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

NCT IDNCT07229157
Org study ID20250003

Timeline

Milestones

Study start2025-10-22actual
Study first posted2025-11-14actual
Last update posted2026-01-23actual
Primary completion2026-08-26estimated
Study completion2026-08-26estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

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).

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

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:

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.

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

Safety / tolerability / PK
10
Cardiometabolic biomarkers
2
Other (unclassified)
2

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change from Baseline in Heart Rate

Time frame:Up to Day 171

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Categorical Outliers for HR

Time frame:Up to Day 171

Heart rate, change

descriptive

Safety / tolerability / PK

10 endpoints
Primary/protocol endpoint

Change from Baseline in QTcF for Maridebart Cafraglutide

Time frame:Up to Day 171

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) of Maridebart Cafraglutide

Time frame:Up to Day 171

concentration, descriptive

Secondary/protocol endpoint

Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide

Time frame:Up to Day 171

Cmax

concentration, descriptive

Secondary/protocol endpoint

Change from Baseline in PR Interval

Time frame:Up to Day 171

change from baseline, descriptive

Secondary/protocol endpoint

Categorical Outliers for QTcF

Time frame:Up to Day 171

categorical status, event

Secondary/protocol endpoint

Categorical Outliers for QRS

Time frame:Up to Day 171

categorical status, event

Secondary/protocol endpoint

Number of Participants with Treatment-emergent Changes in Electrocardiogram (ECG) Morphology

Time frame:Up to Day 171

descriptive

Secondary/protocol endpoint

Change from Baseline in QTcF for Moxifloxacin

Time frame:Up to Day 171

change from baseline, descriptive

Secondary/protocol endpoint

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)

Secondary/protocol endpoint

Number of Participants with Anti-maridebart Cafraglutide Antibody Formation

Time frame:Up to Day 232

Immunogenicity (ADA)

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Change from Baseline in QRS Duration

Time frame:Up to Day 171

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Categorical Outliers for PR

Time frame:Up to Day 171

categorical status, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.