Current partner codePEPTIDESDE
NCT07523711·Phase 1·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 1

Enrollment

49

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

COC

Administered orally.

DRUG

Maridebart Cafraglutide

Administered as SC injection.

Timeline

From registration to results.

  1. First posted

    Apr 13, 2026

  2. Study start

    Apr 9, 2026

  3. Primary completion

    Nov 18, 2026

  4. Study completion

    Nov 18, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 20, 2026

Outcomes

What the study measures.

Primary outcomes

Maximum Observed Concentration (Cmax) of COC

Time frame · Day 1 up to Day 89

Area Under the Concentration-time Curve (AUC) from Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of COC

Time frame · Day 1 up to Day 89

AUC from Time Zero Extrapolated to Infinity (AUCinf) of COC

Time frame · Day 1 up to Day 89

Secondary outcomes

Plasma Concentrations of Maridebart Cafraglutide

Time frame · Up to Day 142

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Time frame · Day 1 to end of trial (approximately 142 days)

Number of Participants with Serious Adverse Events (SAEs)

Time frame · From screening (Day -28) up to end of trial (approximately 170 days)

Number of Participants Who Develop Anti-maridebart Cafraglutide Antibodies

Time frame · Up to Day 142

Eligibility

Who can take part.

Minimum age
45 Years
Maximum age
65 Years
Sex
FEMALE
Healthy volunteers
No

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.

Study locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Fortrea Clinical Research Unit - Dallas

Dallas, Texas, United States

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Maridebart cafraglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.