Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity

Running, not enrolling · Phase 1

Conditions studied: Overweight, Obesity

In brief

The primary objective of the trial is to evaluate the effect of maridebart cafraglutide on the pharmacokinetics (PK) of a combined oral contraceptive (COC) in postmenopausal female participants living with overweight or obesity.

Key facts

Study ID

NCT07523711

Run by

Amgen

People needed

49

Starts

2026-04-09

Expected to finish

2026-11-18

Last updated by the study team

2026-07-20

Who can join

Age: 45 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be postmenopausal females 45 to 65 years of age. Postmenopausal status must be confirmed based on the protocol-defined criteria.
• Body mass index must be ≥ 25.0 and ≤ 38.0 kg/m\^2.
• Body weight must be stable, with less than 5 kg self-reported change in the 3 months before screening.
• Participants must not have changed their diet or started a nutritional lifestyle modification program within 3 months before screening.
• Other inclusion criteria may apply.

You may not qualify if…

• History or evidence of any clinically significant medical condition, abnormal physical exam, ECG, vital sign, or laboratory finding that could increase risk or interfere with study participation.
• History of diabetes, active diabetes, or hemoglobin A1c 6.5% or higher.
• Endocrine disorders that can cause obesity, such as Cushing's syndrome.
• History of acute or chronic pancreatitis within 1 year before check-in, pancreatic enzyme elevations greater than 2 times the upper limit of normal, or fasting triglycerides greater than 300 mg/dL.
• Bleeding or clotting disorders, abnormal coagulation tests, or a history of venous or arterial blood clots or conditions that increase clot risk.
• LDL cholesterol greater than 159 mg/dL.
• Migraine with aura, normal pressure hydrocephalus, or ischemic optic neuropathy.
• Malignancy within the past 5 years, except nonmelanoma skin cancer.
• Unexplained postmenopausal vaginal bleeding, untreated endometrial disease, or other gynecologic conditions that could worsen with estrogen/progestin therapy.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or uncontrolled thyroid disease.
• Gastroparesis, inability to swallow oral medication, clinically important gastrointestinal disease, malabsorption, uncontrolled inflammatory bowel disease, certain gastrointestinal surgeries, or recent bariatric surgery.
• Clinically significant cardiovascular disease, clinically significant arrhythmia, long QT syndrome, QTcF greater than 470 msec, second- or third-degree atrioventricular block, or clinically important abnormal pulse rate or systolic blood pressure > 150 mmHg or < 90 mmHg, diastolic blood pressure > 95 mmHg or < 50 mmHg.
• Allergy, hypersensitivity, intolerance, or contraindication to maridebart cafraglutide, ethinyl estradiol, or orgestimate.
• Reduced kidney function with estimated glomerular filtration rate 60 mL/min/1.73 m\^2 or lower, ALT or AST greater than 2 times the upper limit of normal, or a history of acute or chronic liver disease, hepatic adenoma, or hepatic carcinoma.
• Hemoglobin or hematocrit below the lower limit of normal.
• Positive HIV test, or positive hepatitis B surface antigen or hepatitis C antibody at screening.
• Lifetime history of suicide attempt, non-suicidal self-injury within 5 years, or unstable major depressive disorder or other severe psychiatric disorder within 2 years.
• Positive pregnancy test at screening or check-in.
• Recent use of medications that could affect study participation, including most prescription or over-the-counter medications, systemic hormone replacement therapy, certain contraceptive hormones, CYP enzyme inducers or inhibitors, GLP-1 receptor or GIP receptor agents, and nonpermitted herbal products, vitamins, or supplements.
• Recent participation in another investigational study, prior participation in this study, or prior exposure to maridebart cafraglutide.
• Tobacco or nicotine use within 3 months before check-in, positive cotinine test, history of alcoholism or drug abuse, positive alcohol or illicit drug testing, recent illicit drug use, or unwillingness to avoid illicit drugs or cannabinoids during the study.
• Recent blood, plasma, or platelet donation.
• Other exclusion criteria may apply.

Where it is running

• Fortrea Clinical Research Unit - Dallas — Dallas, Texas, United States
• Fortrea Clinical Research Unit Inc. - Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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