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OverweightPhase 1NCT07229157

Effect of Maridebart Cafraglutide on the Heart's Electrical Activity

A Phase 1 study testing Maridebart Cafraglutide and Moxifloxacin in people with Overweight and Obesity, run by Amgen at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Overweight, Obesity
What is being tested?
Maridebart Cafraglutide and Moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
2 sitesUnited States
Study dates
22 Oct 2025to 27 Aug 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • To take part in the trial, participants must meet all of the following:
  • 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.
  • Males and females who could become pregnant must agree to use effective birth control as specified in the protocol.
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  • 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.

Who cannot join

  • Participants will not be able to take part if they meet any of the following:
  • Medical Conditions
  • 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.
  • 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.
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  • Kidney function (estimated glomerular filtration rate [eGFR]) < 70 mL/min/1.73 m^2.
  • 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.
  • Uncontrolled thyroid disease (abnormal thyroid-stimulating hormone [TSH] outside 0.4-6.0 mIU/L).
  • Contraindications to moxifloxacin, including history of tendon disorders with quinolone use.
  • History of gastrointestinal surgery or disease that may affect absorption of oral drugs (other than uncomplicated appendectomy or hernia repair).
  • Inability to swallow pills.
  • History of significant esophageal, stomach, or bowel disorders (eg, ulcers, bleeding, Crohn's disease, ulcerative colitis, irritable bowel syndrome, gastroparesis).
  • Current or recent suicidal thoughts (per Columbia Suicide Severity Rating Scale [C-SSRS]).
  • Lifetime history of suicide attempt or behavior.
  • Major depressive disorder within the past 2 years.
  • History of other serious psychiatric disorders (eg, schizophrenia, bipolar disorder).
  • High depression score (patient health questionnaire-9 [PHQ-9] ≥ 15).
  • History or current signs of heart disease (eg, heart attack, congenital defects, valve disease, angina, bypass or stent).
  • History of ischemic optic neuropathy (eye damage from poor blood flow).
  • Diagnosis of sleep apnea. Diagnostic Tests
  • Positive test for human immunodeficiency virus (HIV).
  • Positive test for hepatitis B or C (exceptions apply for prior vaccination or resolved infection).
  • Abnormal vital signs: average blood pressure > 140/90 mmHg or < 90/50 mmHg, or heart rate > 110 or < 40 bpm.
  • 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
  • Use of drugs that affect absorption, metabolism, or elimination within 30 days of dosing.
  • Use of drugs known to prolong QT/QTc within 30 days of dosing.
  • Use of prescription drugs (other than hormone replacement or contraception) within 14 days of dosing.
  • Use of long-acting/slow-release medicines still active within 14 days of dosing.
  • Use of non-prescription products (vitamins, supplements, herbal products) within 7 days of dosing.
  • 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
  • Participation in another investigational drug trial within 30 days or 5 drug half-lives (whichever is longer).
  • Previous exposure to maridebart cafraglutide in this or another trial. Lifestyle
  • Alcohol use > 21 units/week (men) or > 14 units/week (women).
  • Alcohol use within 48 hours before check-in.
  • Positive drug screen or alcohol test at screening or check-in.
  • History of alcohol or drug abuse within 1 year.
  • Use of tobacco/nicotine products within 3 months, or positive cotinine test.
  • Use of caffeine within 48 hours of screening or check-in.
  • Consumption of grapefruit, Seville orange, or related products within 7 days of check-in.
  • Consumption of poppy seed-containing foods within 7 days of check-in. Other
  • Receipt of blood products within 2 months before check-in.
  • Blood donation within 3 months; plasma donation within 2 weeks; platelet donation within 6 weeks.
  • Poor veins for blood draws.
  • Any other reason, in the opinion of the investigator, the participant should not take part.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Fortrea Clinical Research Unit - Dallas

    Dallas, Texas, 75247-4968

  • Fortrea Clinical Research Unit - Daytona Beach

    Daytona Beach, Florida, 32117-5116

Other trials in United States

About this study

Official title: 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

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.

Conditions
Overweight, Obesity
Being tested
Maridebart Cafraglutide, Moxifloxacin, Placebo for Maridebart Cafraglutide, Placebo for Moxifloxacin
Keywords
Overweight, Obesity, Maridebart Cafraglutide, AMG 133, QT/QTc Intervals
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maridebart CafraglutideDrug

    Also called AMG 133

    Participants will receive maridebart cafraglutide SC.

  • MoxifloxacinDrug

    Participants will receive moxifloxacin orally.

  • Placebo for Maridebart CafraglutideDrug

    Participants will receive placebo for maridebart cafraglutide SC.

  • Placebo for MoxifloxacinDrug

    Participants will receive placebo for moxifloxacin orally.

Study groups in NCT07229157
Study groupRoleWhat they receive
Group 1ExperimentalIn 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.
Receives: Drug: Maridebart Cafraglutide; Drug: Placebo for Moxifloxacin
Group 2AExperimentalIn 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.
Receives: Drug: Moxifloxacin; Drug: Placebo for Maridebart Cafraglutide; Drug: Placebo for Moxifloxacin
Group 2BExperimentalIn 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.
Receives: Drug: Moxifloxacin; Drug: Placebo for Maridebart Cafraglutide; Drug: Placebo for Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in QTcF for Maridebart Cafraglutide

    Change from baseline in QTcF for maridebart cafraglutide will be the dependent variable for calculation of model-derived placebo-corrected, change from baseline in QTcF after maridebart cafraglutide dosing.

    Measured: Up to Day 171

Secondary outcomes (13)

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

    Measured: Up to Day 171

  2. Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide

    Measured: Up to Day 171

  3. Change from Baseline in Heart Rate

    Change from baseline in heart rate will be used as the dependent variable for calculation of model-derived placebo-corrected, change from baseline in HR for the by-time point analysis.

    Measured: Up to Day 171

  4. Change from Baseline in PR Interval

    Change from baseline in PR Interval will be used as the dependent variable for calculation of model-derived placebo-corrected, change from baseline in PR for the by-time point analysis.

    Measured: Up to Day 171

  5. Change from Baseline in QRS Duration

    Change from baseline in QRS Duration will be used as the dependent variable for calculation of model-derived placebo-corrected, change from baseline in QRS for the by-time point analysis.

    Measured: Up to Day 171

  6. Categorical Outliers for QTcF

    Measured: Up to Day 171

  7. Categorical Outliers for HR

    Measured: Up to Day 171

  8. Categorical Outliers for PR

    Measured: Up to Day 171

  9. Categorical Outliers for QRS

    Measured: Up to Day 171

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

    Measured: Up to Day 171

  11. Change from Baseline in QTcF for Moxifloxacin

    Change from baseline in QTcF for moxifloxacin will be used as the dependent variable for calculation of model-derived placebo-corrected, change from baseline in QTcF after moxifloxacin dosing for both the assay sensitivity and by-time point analysis.

    Measured: Up to Day 171

  12. Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events

    Measured: Up to Day 232

  13. Number of Participants with Anti-maridebart Cafraglutide Antibody Formation

    Measured: Up to Day 232

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2025
  2. Study start22 Oct 2025
  3. Primary completion27 Aug 2026
  4. Study completion27 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07229157
Sponsor's protocol ID
20250003
Status last verified
Sep 2026
First submitted
13 Nov 2025
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Maridebart Cafraglutide and Moxifloxacin in people with Overweight and Obesity, run by Amgen at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in QTcF for Maridebart Cafraglutide (time frame: Up to Day 171). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07229157.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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