This is an open label phase 1b trial of QX1206 in patients with T2DM and with NAFLD. Laboratory tests and other measurements will be assessed prior to the first dose of study treatment and throughout the study to determine the recommended phase 2 dose. In addition, the preliminary effects of QX1206 on antidiabetic activity and other metabolic parameters will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
QX1206 will be administered orally before bedtime
Centricity Research Toronto LMC.
Toronto, Canada
RECRUITINGRecommended Phase 2 Dose (RP2D)
Time frame: Baseline Day 1 up to Week 12
Hemoglobin A1c (HbA1c)
Change in HbA1c percentage from baseline with QX1206
Time frame: 12 Weeks
Fasting plasma glucose (FPG)
Change in FPG mg/dL from baseline with QX1206
Time frame: 12 Weeks
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Change in the HOMA-IR from baseline with QX1206
Time frame: 12 Weeks
Fasting insulin
Change in fasting insulin pmol/L from baseline with QX1206
Time frame: 12 Weeks
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