Obesity, Overweight
Conditions
Keywords
AMG 133
Brief summary
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
DRUGMaridebart cafraglutide
Administered subcutaneously.
DEVICEAutoinjector
The AI will be used by participants to self-administer SC doses of maridebart cafraglutide.
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration | 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 | Weeks 12, 16, and 20 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Who Experience Device-related Adverse Events | Up To 37 weeks |
| Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs: From baseline (Day 1) up to end of trial (approximately 37 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 41 weeks). |
| Plasma Concentration of Maridebart Cafraglutide at Week 24 | Week 24 |
| Percent Change From Baseline in Body Weight at Week 24 | Baseline and Week 24 |
Countries
United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed