New obesity drug put to the heart safety test
NCT ID NCT07229157
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is checking whether maridebart cafraglutide, a new weight-loss drug, affects the heart's electrical activity. About 81 adults with overweight or obesity will receive the drug or a placebo, and their heart rhythms will be closely monitored. The main goal is safety, not weight loss.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- maridebart cafraglutide (AMG 133)
- What this could lead to
- If successful, this study could show that maridebart cafraglutide is safe for the heart, supporting its development as a weight-loss treatment.
- What could go wrong
- This is a very early Phase 1 safety study with only 81 people. It is not designed to test weight loss, and the drug may still fail in later trials or have other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
81 people
The number who actually took part.
- Started
-
Oct 2025
- Expected to finish
-
Aug 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Obesity are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247-4968, United States
-
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, 32117-5116, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Custom knee guides put to the test in obese patients
- A pill for obesity? early human trial puts MDR-001 to the test
- Can a weekly shot help people who still struggle with weight after bariatric surgery?
- Do GLP-1 Weight-Loss drugs change how teens eat and feel?
- Can electrical muscle stimulation boost exercise benefits after menopause?
- Can a vegan diet shield police officers from heart disease?