Pila Pharma AB (”Pila Pharma” or ”the Company”) announced on September 29, 2026, that the clinical trial site conducting the safety part (Part 1) of PP-CT04 has been initiated and activated, whereby recruitment of participants now commences. The initiation is the final step before participants can be enrolled and ensures that investigators and trial staff have been trained in the study protocol, that regulatory and ethics documentation is in place, and that the site’s procedures and facilities meet GCP requirements.
In summary, the start of recruitment means that Pila Pharma has moved from regulatory approval to clinical execution in obesity. PP-CT04 tests XEN-D0501 for the first time at substantially higher doses and at longer and clinically relevant treatment durations, thereby addressing the tolerability question left unanswered in PP-CT02, the prior four-week clinical trial, which tested XEN-D0501 at 4 mg twice daily in people with obesity and type 2 diabetes. At the same time, the dose-finding component of Part 1 is expected to lay the foundation for continued clinical development in type 2 diabetes and erythromelalgia, and potentially additional indications.
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