9 results
The primary objectives are: 1) to determine the effect of bile acids on glucose uptake in brown adipose tissue; 2) to determine the effect of bile acids on whole body energy expenditure and 3) to determine the effect of bile acids on skeletal muscle…
To study potential abnormal functioning of the bile salt-FXR-FGF19 axis in patients with clinically quiescent Crohn*s colitis.
The main objective of this study is to test the effects of combined SGLT1 and SGLT2 inhibition with sotagliflozin on hemoconcentration and plasma volume in patients with heart failure.
The main objectives of the study are to demonstrate whether sotagliflozin reduces the composite of CV (cardiovascular) death and HHF (hospitalization for heart failure) as compared to placebo in diabetic patients after admission for WHF (worsening…
This study is designed to demonstrate the CV and renal effects of sotagliflozin in patients with T2D, high CV risk, and moderate renal impairment. One of the major objectives of this study is to fulfill the regulatory mandate that any new therapy…
Based on results from a comparative review (Paoletti 2013), we hypothesize that if the toxicity profile and the PK parameters observed in children treated at the adult RP2D are similar to those in adults; escalating to the MTD is not necessarily…
To assess efficacy and safety of ivosidenib/enasidenib vs. placebo in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic…
The primary objective of this study is to:• Determine the safety and tolerability of AG-120 and AG-221 when administered with induction and consolidation therapy in patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate…
Phase 1b Dose-finding Stage Primary Objectives· To assess the safety and tolerability of the combination treatments of oral AG-120 when administered with subcutaneous (SC) azacitidine and oral AG-221 when administered with SC azacitidine in subjects…