Recruitment Complete
Sponsor ID
20210181
Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are OverweightMARITIME-1
Study Details
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
Protocol Summary
Primary Outcome Measures
Percent Change From Baseline in Body Weight at Week 72
Timeframe: Baseline and Week 72
Secondary Outcome Measures
Change From Baseline in Waist Circumference at Week 72
Timeframe: Baseline and Week 72
Participant achieving ≥ 5% reduction in body weight from baseline at week 72
Timeframe: Week 72
Participant achieving ≥ 10% reduction in body weight from baseline at week 72
Timeframe: Week 72
Participant achieving ≥ 15% reduction in body weight from baseline at week 72
Timeframe: Week 72
Participant achieving ≥ 20% reduction in body weight from baseline at week 72
Timeframe: Week 72
Change From Baseline in Systolic Blood Pressure (SBP) at Week 72
Timeframe: Baseline and Week 72
Percent Change From Baseline in Fasting Triglycerides at Week 72
Timeframe: Baseline and Week 72
Change From Baseline in Fasting Glucose at Week 72
Timeframe: Baseline and Week 72
Change From Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72
Timeframe: Baseline and Week 72
Change From Baseline in Body Weight at Week 72
Timeframe: Baseline and Week 72
Change From Baseline in Body Mass Index (BMI) at Week 72
Timeframe: Baseline and Week 72
Change From Baseline in Hemoglobin A1c at Week 72
Timeframe: Baseline and Week 72
Percent Change From Baseline in Fasting Insulin at Week 72
Timeframe: Baseline and Week 72
Change From Baseline in Glycemic Status at Week 72
Timeframe: Baseline and Week 72
Percent Change From Baseline in Fasting Lipid Parameters at Week 72
Timeframe: Baseline and Week 72
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 72
Timeframe: Baseline and Week 72
Percent Change From Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72
Timeframe: Baseline and Week 72
Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72
Timeframe: Baseline and Week 72
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 88 weeks
Plasma Concentration of Maridebart Cafraglutide at Week 72
Timeframe: Week 72
Locations
Location
Emeritus Research Camberwell
Camberwell, VIC, Australia, 3124
Status
Recruiting
Location
Novatrials
Charlestown, NSW, Australia, 2290
Status
Recruiting
Location
Emeritus Research Sydney
Botany, NSW, Australia, 2019
Status
Recruiting
Location
Canopy Clinical Sutherland
Miranda, NSW, Australia, 2228
Status
Recruiting
Location
Fusion Clinical Research
Norwood, SA, Australia, 5067
Status
Recruiting
Location
Canopy Clinical Wollongong
Wollongong, NSW, Australia, 2500
Status
Recruiting
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