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CLINICAL

Elcelyx has validated the concept of a gut-restricted metformin through completion of six 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 a metformin with an improved benefit-risk profile.

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
Planned
Single dose PK in renal impairment
Completed
3-month efficacy/safety
Completed
4-month dose-ranging
Planned
6-month noninferiority
Planned
6-month in moderate renal impairment
Planned