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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Maridebart cafraglutide will be administered SC.
Placebo will be administered SC.
ProSciento, Inc. - Main Clinic
Chula Vista, California, United States
Change from Baseline in M-value from Hyperinsulinemic-euglycemic Clamp at Week 25
Time frame: Baseline and Week 25
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Time frame: Up to Week 41
Plasma Concentration of Maridebart Cafraglutide at Week 25
Time frame: Week 25
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
Time frame: Up to Week 41
Change from Baseline in Total Insulin Secretion at Week 25
Measured as area under the curve (AUC) of insulin secretion rate (ISR) from hyperglycemic clamp (ISR0-120min).
Time frame: Baseline and Week 25
Change from Baseline in First Phase Incremental ISR from Hyperglycemic Clamp (ISR0-8min) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Second Phase Insulin Secretion at Week 25
Measured as AUC of ISR from hyperglycemic clamp (ISR20-120min).
Time frame: Baseline and Week 25
Change from Baseline in Maximum Insulin Secretion at 8 Minutes at Week 25
Measured as incremental ISR responses to arginine from hyperglycemic clamp at 8 minutes (ISRarg0-8min).
Time frame: Baseline and Week 25
Change from Baseline in Maximum Insulin Secretion at 30 Minutes at Week 25
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Measured as incremental ISR responses to arginine from hyperglycemic clamp at 30 minutes (ISRarg0-30min).
Time frame: Baseline and Week 25
Change from Baseline in ISR at Week 25
Measured as total AUC (ISR0-240min) from standardized mixed meal tolerance test (sMMTT).
Time frame: Baseline and Week 25
Change from Baseline in Clamp Disposition Index (cDI) at Week 25
Calculated as product of M-value and ISR0-120min from the hyperglycemic clamp.
Time frame: Baseline and Week 25
Change from Baseline in Post-meal Glucose Concentrations During sMMTT (Total and Incremental AUC0-240min) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fasting Glucose Concentration at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fasting Glucagon Concentration at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Glucagon Concentration During sMMTT (Total and Incremental AUC0-240min) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fasting Triglycerides at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fasting High-density Lipoprotein-cholesterol (HDL-C) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fasting Non-HDL-C at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Triglyceride Concentration During sMMTT (Total and Incremental AUC0-240min) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fasting Free Fatty Acids (FFA) Concentration (During Hyperinsulinemic-euglycemic Clamp and sMMTT) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in FFA Concentrations During sMMTT (Total AUC0-240min) at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Percentage Body Fat at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Body Fat Mass at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Lean Body Mass at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Body Weight at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Waist Circumference at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Hunger Fasting Appetite Visual Analog Scale (VAS) Score at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Satiety Fasting Appetite VAS Score at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fullness Fasting Appetite VAS Score at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Prospective Food Consumption Fasting Appetite VAS Score at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Overall Fasting Appetite VAS Score at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Hunger Appetite VAS Score During sMMTT at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Satiety Appetite VAS Score During sMMTT at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Fullness Appetite VAS Score During sMMTT at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Prospective Food Consumption Appetite VAS Score During sMMTT at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Overall Appetite VAS Score During sMMTT at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Food Craving Inventory (FCI) Score at Week 25
Time frame: Baseline and Week 25
Change from Baseline in Caloric Intake During Ad Libitum Meal at Week 25
Time frame: Baseline and Week 25