NCT07871409Not yet recruitingPhase 3
Home Self-administration of Maridebart Cafraglutide With Autoinjector in Adults Living With Obesity or Overweight
A Phase 3 Multicenter, Open-label, Single-arm Trial Evaluating Home Self-Administration of Subcutaneous Maridebart Cafraglutide Via Autoinjector in Adult Participants Living With Obesity or Overweight Without Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- First submitted
- 7 Oct 2026
- Start date
- 28 Oct 2026
- Primary completion date
- 16 Jun 2027
- Lead sponsor
- Amgen
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07871409
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 230
- From 28 Oct 2026 to the primary completion date, 16 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or planned surgical, endoscopic, or device-based treatment for obesity.
- Previous participation in a Maridebart Cafraglutide trial.
Other illness
- Obesity induced by other endocrinologic disorders.
- 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.
Other
- Change in body weight \> 5 kg within last 90 days.
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charter Research The Villages Coordinator of this site? Confirm its status | The Villages | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.