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NCT07523711 · Amgen

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

What this study is about

The primary objective of the trial is to evaluate the effect of maridebart cafraglutide on the how the drug moves through the body (PK) of a combined taken by mouth contraceptive (COC) in postmenopausal female participants living with overweight or obesity.

View original scientific description

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

  • Daytona Beach, Florida
  • Dallas, Texas
  • Madison, Wisconsin

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations

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1 of 45 participants interested
2% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Daytona Beach

Florida

Location available
RECRUITING

Dallas

Texas

Location available
RECRUITING

Madison

Wisconsin

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Overweight Treatment in Daytona Beach?

Join others in Florida exploring innovative treatment options through clinical research

Overweight Treatment Options in Daytona Beach, Florida

If you're searching for Overweight treatment in Daytona Beach, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Daytona Beach, Dallas, Madison and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Overweight. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Florida
Now Enrolling
Up to 45 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Overweight?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Overweight

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Overweight Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07523711. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.