Home Self-administration of Maridebart Cafraglutide With Autoinjector in Adults Living With Obesity or Overweight
RecruitingPhase 3
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
Who can join
Ages 18 to 99 · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Maridebart cafraglutide (drug)
- Autoinjector (device)
Sponsor: Amgen · Participants: 230 · Started: Oct 15, 2026
Contact the study team
- Amgen Call Center · Phone: 866-572-6436
Official record on ClinicalTrials.gov — NCT07871409
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.