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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

Sponsor: Amgen · Participants: 230 · Started: Oct 15, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07871409

Locations in the U.S.

CaliforniaApex Clinical Research, San Diego
FloridaResearch Institute of South Florida, Miami
Southern Clinical Research, Miami
Clinical Neuroscience Solutions LLC, Orlando
Florida Institute for Clinical Research, Orlando
Charter Research - The Villages, The Villages
GeorgiaNsc Research, Johns Creek
North Georgia Clinical Research, Woodstock
IdahoSolaris Clinical Research, Meridian
IllinoisAlliance For Multispecialty Research - Oak Brook, Oak Brook
MarylandFlourish Research, Bowie
New YorkRochester Clinical Research, Rochester
North CarolinaCentricity Research, Morehead City
OhioCentricity Research Dublin, Columbus
OklahomaEpic Medical Research - Oklahoma, Chickasha
South CarolinaTribe Clinical Research LLC Dba Mountain View Clinical Research, Greenville
TexasCedar Health Research, LLC, Dallas
Cedar Health Research- Texas Native Health, Dallas
Epic Medical Research - Red Oak, DeSoto
Soma Clinical Trials, LLC, Denison
Biopharma Informatic, LLC, Houston
Research Physicians Network LLC, Houston
Texas Institute of Cardiology, McKinney
North Hills Medical Research, North Richland Hills

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.