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Will Be Recruiting
Sponsor ID
20250207

Home Self-administration of Maridebart Cafraglutide With Autoinjector in Adults Living With Obesity or OverweightMARITIME-PEN

Sponsor ID
20250207
Clinicaltrials.gov ID
NCT07871409
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
Maridebart Cafraglutide
Type
Interventional
Masking
None (Open Label)
Enrollment
230
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration

Timeframe: 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

Timeframe: Weeks 12, 16, and 20

Secondary Outcome Measures

Number of Participants Who Experience Device-related Adverse Events

Timeframe: Up To 37 weeks

Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: 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

Timeframe: Week 24

Percent Change From Baseline in Body Weight at Week 24

Timeframe: Baseline and Week 24

Locations

Location
Status
Contact Us
Location
Charter Research - The Villages
The Villages, FL, United States, 32162
Status
Recruiting
Study Info
Age
18 - 99 Years
Condition
  • Weight Loss & Obesity
    • Sex
    All
    Trial Dates
    Oct 2026 - Jun 2027
    Inclusion and Exclusion 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.