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

NCT07523711 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 20230161
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

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

Overweight; Obesity

Keywords

Maridebart Cafraglutide; AMG 133; Norgestimate; Ethinyl Estradiol

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Concentration (Cmax) of COC

  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

  Day 1 up to Day 89

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

  Day 1 up to Day 89

Secondary Outcomes (4)

• Plasma Concentrations of Maridebart Cafraglutide

  Up to Day 142

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

  Day 1 to end of trial (approximately 142 days)

• Number of Participants with Serious Adverse Events (SAEs)

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

• Number of Participants Who Develop Anti-maridebart Cafraglutide Antibodies

  Up to Day 142

Study Arms (1)

COC + Maridebart Cafraglutide

EXPERIMENTAL

Participants will receive COC orally and maridebart cafraglutide subcutaneously (SC).

Drug: COC; Drug: Maridebart Cafraglutide

Interventions

COC DRUG

Administered orally.

COC + Maridebart Cafraglutide

Maridebart Cafraglutide DRUG

Administered as SC injection.

Also known as: AMG 133

COC + Maridebart Cafraglutide

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 to 35.0 kg/m².
• 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.

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 blood pressure or pulse rate.
• 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 m² 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (3)

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, 32117-5116, United States

RECRUITING

Fortrea Clinical Research Unit - Dallas

Dallas, Texas, 75247-4968, United States

RECRUITING

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, 53704-2526, United States

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): October 7, 2026
• Study Completion (Estimated): October 7, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (3)