Metformin DR Clinical Development Program

Elcelyx has demonstrated the concept of a gut-restricted metformin through completion of ten clinical trials in both healthy and type 2 diabetes subjects. Clinical trial results support a product candidate intended to address the extensive unmet need for patients who cannot optimally use currently available metformin.

Metformin DR Clinical Development Program


CLINICAL STUDIES PHASE I PHASE II PHASE III
Single and multidose PK/PD
Completed
Formulation bridging PK
Completed
Drug-drug interaction and food effect PK
Ongoing
Single dose PK in renal impairment
Completed
3-month efficacy/safety in normal renal function
Completed
4-month dose-ranging in normal renal function
Completed
Efficacy/safety in renal impairment
Planned