Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity
Recruiting
Phase 1Interventional Study
OverweightObesity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 – 65
Sex
Female
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for
This trial is looking for women who are between 45 and 65 years old and have a bit of extra weight. To join, they can't have certain health issues like diabetes, heart problems, or a history of certain cancers. It's also important that their overall health is stable and they haven’t made big changes to their diet recently.
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Answer a few quick questions to see if you may meet the eligibility requirements.
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.
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Eligibility Criteria
Inclusion Criteria
1. Participants must be postmenopausal females 45 to 65 years of age. Postmenopausal status must be confirmed based on the protocol-defined criteria.
2. Body mass index must be ≥ 25.0 and ≤ 38.0 kg/m\^2.
3. Body weight must be stable, with less than 5 kg self-reported change in t…
Inclusion Criteria
1. Participants must be postmenopausal females 45 to 65 years of age. Postmenopausal status must be confirmed based on the protocol-defined criteria.
2. Body mass index must be ≥ 25.0 and ≤ 38.0 kg/m\^2.
3. Body weight must be stable, with less than 5 kg self-reported change in the 3 months before screening.
4. Participants must not have changed their diet or started a nutritional lifestyle modification program within 3 months before screening.
5. Other inclusion criteria may apply.
Exclusion Criteria
1. 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.
2. History of diabetes, active diabetes, or hemoglobin A1c 6.5% or higher.
3. Endocrine disorders that can cause obesity, such as Cushing's syndrome.
4. 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.
5. Bleeding or clotting disorders, abnormal coagulation tests, or a history of venous or arterial blood clots or conditions that increase clot risk.
6. LDL cholesterol greater than 159 mg/dL.
7. Migraine with aura, normal pressure hydrocephalus, or ischemic optic neuropathy.
8. Malignancy within the past 5 years, except nonmelanoma skin cancer.
9. Unexplained postmenopausal vaginal bleeding, untreated endometrial disease, or other gynecologic conditions that could worsen with estrogen/progestin therapy.
10. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or uncontrolled thyroid disease.
11. Gastroparesis, inability to swallow oral medication, clinically important gastrointestinal disease, malabsorption, uncontrolled inflammatory bowel disease, certain gastrointestinal surgeries, or recent bariatric surgery.
12. 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.
13. Allergy, hypersensitivity, intolerance, or contraindication to maridebart cafraglutide, ethinyl estradiol, or orgestimate.
14. 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.
15. Hemoglobin or hematocrit below the lower limit of normal.
16. Positive HIV test, or positive hepatitis B surface antigen or hepatitis C antibody at screening.
17. 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.
18. Positive pregnancy test at screening or check-in.
19. 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.
20. Recent participation in another investigational study, prior participation in this study, or prior exposure to maridebart cafraglutide.
21. 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.
22. Recent blood, plasma, or platelet donation.
23. Other exclusion criteria may apply.
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