A Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants with Type 2 Diabetes Mellitus
Study Details
The primary objective of this study is to determine the effect of maridebart cafraglutide relative to placebo on insulin sensitivity in participants with Type 2 Diabetes Mellitus (T2DM) treated with stable dose of metformin.
Protocol Summary
Change from Baseline in M-value from Hyperinsulinemic-euglycemic Clamp at Week 25
Timeframe: Baseline and Week 25
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Timeframe: Up to Week 41
Plasma Concentration of Maridebart Cafraglutide at Week 25
Timeframe: Week 25
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
Timeframe: Up to Week 41
Change from Baseline in Total Insulin Secretion at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in First Phase Incremental ISR from Hyperglycemic Clamp (ISR0-8min) at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Second Phase Insulin Secretion at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Maximum Insulin Secretion at 8 Minutes at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Maximum Insulin Secretion at 30 Minutes at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in ISR at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Clamp Disposition Index (cDI) at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Post-meal Glucose Concentrations During sMMTT (Total and Incremental AUC0-240min) at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Fasting Glucose Concentration at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Fasting Glucagon Concentration at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Glucagon Concentration During sMMTT (Total and Incremental AUC0-240min) at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Fasting Triglycerides at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Fasting High-density Lipoprotein-cholesterol (HDL-C) at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Fasting Non-HDL-C at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Triglyceride Concentration During sMMTT (Total and Incremental AUC0-240min) at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Fasting Free Fatty Acids (FFA) Concentration (During Hyperinsulinemic-euglycemic Clamp and sMMTT) at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in FFA Concentrations During sMMTT (Total AUC0-240min) at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Percentage Body Fat at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Body Fat Mass at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Lean Body Mass at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Body Weight at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Waist Circumference at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Hunger Fasting Appetite Visual Analog Scale (VAS) Score at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Satiety Fasting Appetite VAS Score at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Fullness Fasting Appetite VAS Score at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Prospective Food Consumption Fasting Appetite VAS Score at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Overall Fasting Appetite VAS Score at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Hunger Appetite VAS Score During sMMTT at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Satiety Appetite VAS Score During sMMTT at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Fullness Appetite VAS Score During sMMTT at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Prospective Food Consumption Appetite VAS Score During sMMTT at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Overall Appetite VAS Score During sMMTT at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Food Craving Inventory (FCI) Score at Week 25
Timeframe: Baseline and Week 25
Change from Baseline in Caloric Intake During Ad Libitum Meal at Week 25
Timeframe: Baseline and Week 25