Actively Recruiting
Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity
Led by Amgen · Updated on 2026-04-27
45
Participants Needed
3
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be postmenopausal females aged 45 to 65 years
- Body mass index must be between 25.0 and 35.0 kg/m²
- Body weight must be stable with less than 5 kg change in the 3 months before screening
- No diet or nutritional lifestyle changes started within 3 months before screening
- Additional inclusion criteria may apply
You will not qualify if you...
- History or evidence of any significant medical condition or abnormal exam that could increase risk or interfere with participation
- History of diabetes, active diabetes, or hemoglobin A1c of 6.5% or higher
- Endocrine disorders causing obesity, such as Cushing's syndrome
- History of pancreatitis within 1 year, elevated pancreatic enzymes, or fasting triglycerides over 300 mg/dL
- Bleeding or clotting disorders, abnormal coagulation tests, or history of blood clots
- 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 or untreated endometrial disease
- Personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2, or uncontrolled thyroid disease
- Gastrointestinal diseases affecting medication absorption or recent bariatric surgery
- Significant cardiovascular disease or arrhythmias
- Allergy or intolerance to maridebart cafraglutide, ethinyl estradiol, or orgestimate
- Reduced kidney function or liver disease
- Low hemoglobin or hematocrit
- Positive HIV, hepatitis B, or hepatitis C tests
- History of suicide attempt, self-injury, or severe psychiatric disorder
- Positive pregnancy test
- Recent use of medications affecting study participation
- Recent participation in other investigational studies or prior exposure to maridebart cafraglutide
- Tobacco or nicotine use within 3 months before check-in or positive cotinine test
- History of alcoholism, drug abuse, or positive substance tests
- Recent blood, plasma, or platelet donation
- Other exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, United States, 32117-5116
Actively Recruiting
2
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, United States, 75247-4968
Actively Recruiting
3
Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin, United States, 53704-2526
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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