Aphaia Pharma, a clinical-stage biopharmaceutical company harnessing precision-targeted drug delivery technology for the treatment and prevention of metabolic diseases, announced that it has enrolled the first patient as part of a Phase 2 study evaluating the safety and efficacy of its lead drug candidate, APH-012, to induce weight loss in individuals with obesity.
The study has been approved by the U.S. Food and Drug Administration (FDA) and by the German Federal Institute for Drugs and Medical Devices (BfArM) and will be conducted in the USA and Germany. The Phase 2 trial (NCT05385978) is a randomized, double-blind, placebo-controlled, proof-of-concept study that will evaluate the safety and efficacy of APH-012 in approximately 150 adults with obesity. Patients will be placed in two cohorts and will be randomized to receive a once daily dose of either APH-012 or APH-012P, a matching placebo, prior to main daily meals for 6 months (Cohort 1) or 12 months (Cohort 2). The primary endpoint of the trial is the change from baseline in percent weight compared to placebo.
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