Will Be Recruiting
Sponsor ID
20230220
Maridebart Cafraglutide Versus Semaglutide in Participants with Type 2 DiabetesMARITIME-T2D-3
Study Details
The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.
Protocol Summary
Primary Outcome Measures
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]
Timeframe: Baseline to Week 68
Secondary Outcome Measures
Change from Baseline in HbA1c at week 68 [Superiority]
Timeframe: Baseline to Week 68
Percent Change from Baseline in Body Weight at Week 68
Timeframe: Baseline to Week 68
Percentage of Participants Achieving HbA1c < 7.0% at Week 68
Timeframe: Week 68
Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68
Timeframe: Week 68
Percentage of Participants Achieving HbA1c < 5.7% at Week 68
Timeframe: Week 68
Change from Baseline in Fasting Plasma Glucose at Week 68
Timeframe: Baseline to Week 68
Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline at Week 68
Timeframe: Baseline to Week 68
Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 68
Timeframe: Baseline to Week 68
Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 68
Timeframe: Baseline to Week 68
Percentage of Participants Achieving HbA1c ≤ 6.5% and Weight Reduction ≥ 10% from Baseline at Week 68
Timeframe: Baseline to Week 68
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: Up To 81 Weeks
Number of Participants Experiencing ≥ Level 2 American Diabetes Association (ADA) Defined Hypoglycemic Episodes
Timeframe: Up To 81 Weeks
Plasma Concentration of Maridebart Cafraglutide at Week 68
Timeframe: Week 68
Locations
No locations found.