NCT07871409 · Amgen
Home Self-administration of Maridebart Cafraglutide With Autoinjector in Adults Living With Obesity or Overweight
(MARITIME-PEN)
What this study is about
The main objective of this study is to assess participants' ability to self-administer injected under the skin doses of maridebart cafraglutide at home using an autoinjector device.
View original scientific description
The main objective of this study is to assess participants' ability to self-administer subcutaneous doses of maridebart cafraglutide at home using an autoinjector device.
Interventions
DRUG
Maridebart cafraglutide
Administered subcutaneously.
DEVICE
Autoinjector
The AI will be used by participants to self-administer SC doses of maridebart cafraglutide.
Primary outcome measures
Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration
Time frame: Weeks 12, 16, and 20
Percentage of Participants Who Successfully Self-inject a Full Dose Among All Participants Who Entered the Home Self-administration Phase at Each Scheduled Home Administration
Time frame: Weeks 12, 16, and 20
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
- Body mass index (BMI) ≥ 30 kilograms per meter square (kg/m\^2), or BMI ≥ 27 to \< 30 kg/m\^2 with one of the following:
- hypertension: treated, or with systolic blood pressure ≥ 130 millimeters of mercury (mmHg) or diastolic blood pressure ≥ 80 mmHg
- dyslipidemia: treated or previously diagnosed high cholesterol, high triglycerides, or low HDL cholesterol.
- history of obstructive sleep apnea
- history of cardiovascular disease
- history of fatty liver disease (including metabolic dysfunction-associated steatotic liver disease \[MASLD\] or metabolic dysfunction-associated steatohepatitis \[MASH\])
- At least 1 unsuccessful attempt at weight loss by diet and exercise.
- Contraception for females.
- Willingness to follow trial procedures for the duration of the trial.
Exclusion criteria
- Obesity induced by other endocrinologic disorders.
- Change in body weight \> 5 kg within last 90 days.
- Previous or planned surgical, endoscopic, or device-based treatment for obesity.
- History of malignancy within the past 5 years.
- Type 1 or Type 2 diabetes mellitus.
- History of chronic pancreatitis or history of acute pancreatitis within last 180 days.
- Family or personal history of medullary thyroid cancer.
- Previous participation in a Maridebart Cafraglutide trial.
Where
- San Diego, California
- Miami, Florida
- Orlando, Florida
- The Villages, Florida
- Johns Creek, Georgia
- Woodstock, Georgia
- Meridian, Idaho
- Oak Brook, Illinois
- Bowie, Maryland
- Rochester, New York
- Morehead City, North Carolina
- Columbus, Ohio
And 8 more locations — see the full list below.
Related conditions & keywords
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 Nov 9, 2026 · Source of record for eligibility and locations