Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are OverweightMARITIME-2
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
Percent Change from Baseline in Body Weight at Week 72
Timeframe: Baseline and Week 72
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: Baseline and Week 72
Participant achieving ≥ 10% reduction in body weight from baseline at week 72
Timeframe: Baseline and Week 72
Participant achieving ≥ 15% reduction in body weight from baseline at week 72
Timeframe: Baseline and 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 Plasma Glucose at Week 72
Timeframe: Baseline and Week 72
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72
Timeframe: Baseline and Week 72
Participant achieving HbA1c < 7% at week 72
Timeframe: 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
Participant achieving ≥ 20% reduction in body weight from baseline at week 72
Timeframe: Baseline and Week 72
Change from Baseline in Body Mass Index (BMI) at Week 72
Timeframe: Baseline and Week 72
Participant achieving HbA1c ≤ 6.5% at week 72
Timeframe: Week 72
Participant achieving HbA1c < 5.7%, at week 72
Timeframe: Week 72
Percent Change from Baseline in Fasting Insulin 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 Urine Albumin-to-creatinine Ratio (uACR) at Week 72
Timeframe: Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol
Timeframe: Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of Non-high-density Lipoprotein Cholesterol (non-HDL-C)
Timeframe: Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of Low-density Lipoprotein Cholesterol (LDL-C)
Timeframe: Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C)
Timeframe: Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of High-density Lipoprotein Cholesterol (HDL-C)
Timeframe: Baseline and Week 72
Change from Baseline in Diastolic Blood Pressure DBP 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 who Experienced Treatment-emergent Adverse Events
Timeframe: Up to Week 84
Number of Participants who Experienced Serious Adverse Events
Timeframe: Up to Week 84
Plasma Concentration of Maridebart Cafraglutide at Week 72
Timeframe: Week 72