The main purpose of this study is to assess the effect of RO7204239 on insulin sensitivity versus placebo in participants with T2DM and obesity or overweight.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Profil Institut für Stoffwechselforschung
Neuss, North Rhine-Westphalia, Germany
RECRUITINGChange From Baseline in M-value in a Hyperinsulinemic Euglycemic Glucose Clamp (HEC) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 and 24
Time frame: Baseline, Week 12, Week 24
Change From Baseline in Glucose Metabolism Assessed Using Fasting Glucose Test at Weeks 12 and 24
Time frame: Baseline, Week 12, Week 24
Change From Baseline in Glucose Metabolism Assessed Using Insulin Test at Weeks 12 and 24
Time frame: Baseline, Week 12, Week 24
Change From Baseline in Glucose Metabolism Assessed Using C-peptide Test at Weeks 12 and 24
Time frame: Baseline, Week 12, Week 24
Change From Baseline in Blood Lipid Profiles at Weeks 12 and 24
Time frame: Baseline, Week 12, Week 24
Change From Baseline in Body Weight at Weeks 12 and 24
Time frame: Baseline, Week 12, Week 24
Change From Baseline in Waist Circumference at Weeks 12 and 24
Time frame: Baseline, Week 12, Week 24
Change From Baseline in Waist to Height Ratio at Weeks 12 and 24
Time frame: Baseline, Week 12, Week 24
Change From Baseline in Total Lean Tissue Volume and Total Adipose Tissue Volume From Abdominal Magnetic Resonance Imaging (MRI) at Weeks 12 and 24
Reference Study ID Number: BP45980 https://forpatients.roche.com/
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Time frame: Baseline, Week 12, Week 24
Change From Baseline in Muscle Volume From Thigh Muscle MRI at Weeks 12 and 24
Time frame: Baseline, Week 12, Week 24
Change From Baseline in Muscle Fat Infiltration From Thigh Muscle MRI at Weeks 12 and 24
Time frame: Baseline, Week 12, Week 24
Number of Participants With Adverse Events (AEs)
Time frame: Up to Week 48
Number of Participants With Local and Systemic Injection Reactions
Time frame: Up to Week 48