OverweightPhase 1NCT07523711
Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity
A Phase 1 study testing COC and Maridebart Cafraglutide in people with Overweight and Obesity, run by Amgen at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- COC and Maridebart Cafraglutide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Apr 2026to 18 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247-4968
Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin, 53704-2526
About this study
Official title: A Phase 1, Open-label Study to Assess the Effect of Maridebart Cafraglutide (AMG 133) on the Pharmacokinetics of Oral Contraceptives in Postmenopausal Female Participants Living With Overweight or Obesity
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
- Being tested
- COC, Maridebart Cafraglutide
- Keywords
- Maridebart Cafraglutide, AMG 133, Norgestimate, Ethinyl Estradiol
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COCDrug
Administered orally.
Maridebart CafraglutideDrug
Also called AMG 133
Administered as SC injection.
| Study group | Role | What they receive |
|---|---|---|
| COC + Maridebart Cafraglutide | Experimental | Participants will receive COC orally and maridebart cafraglutide subcutaneously (SC). Receives: Drug: COC; Drug: Maridebart Cafraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax) of COC
Measured: 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
Measured: Day 1 up to Day 89
AUC from Time Zero Extrapolated to Infinity (AUCinf) of COC
Measured: Day 1 up to Day 89
Secondary outcomes (4)
Plasma Concentrations of Maridebart Cafraglutide
Measured: Up to Day 142
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 to end of trial (approximately 142 days)
Number of Participants with Serious Adverse Events (SAEs)
Measured: From screening (Day -28) up to end of trial (approximately 170 days)
Number of Participants Who Develop Anti-maridebart Cafraglutide Antibodies
Measured: Up to Day 142
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start9 Apr 2026
- Primary completion18 Nov 2026 (estimated)
- Study completion18 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523711
- Sponsor's protocol ID
- 20230161
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Assess the Effect of Maridebart Cafraglutide (AMG 133) on the Pharmacokinetics of Oral Contraceptives in Postmenopausal Female Participants Living With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07523711
- Acronym / sponsor ID
- 20230161
- Conditions
- Overweight, Obesity
- Keywords
- Maridebart Cafraglutide, AMG 133, Norgestimate, Ethinyl Estradiol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 18 Nov 2026 (estimated)
- Study completion
- 18 Nov 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COC + Maridebart Cafraglutide | Experimental | Drug: COC, Drug: Maridebart CafraglutideParticipants will receive COC orally and maridebart cafraglutide subcutaneously (SC). |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COCAdministered orally. | Drug | COC + Maridebart Cafraglutide |
| Maridebart CafraglutideAlso: AMG 133Administered as SC injection. | Drug | COC + Maridebart Cafraglutide |
Primary outcome
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
4 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COC and Maridebart Cafraglutide in people with Overweight and Obesity, run by Amgen at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Concentration (Cmax) of COC (time frame: Day 1 up to Day 89). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.