29/09/2026
: FIRST CLINICAL SITE INITIATED AND ACTIVATED, ENROLLMENT COMMENCES FOR SAFETY PART 1 OF PP-CT04, A 12-WEEK CLINICAL TRIAL IN PEOPLE LIVING WITH OBESITY
PILA PHARMA is delighted to share that following site initiation visit, the site has been activated and is enabled to start enrollment of patients for PP-CT04, our next clinical trial in people living with ! 🌟
As a reminder: PP-CT04 is a two-part, randomised, double-blind, placebo-controlled, parallel-group, 12‑week trial investigating the safety, tolerability, pharmacokinetics and efficacy of PILA PHARMA's investigational candidate, the oral small molecule antagonist XEN-D0501, in obese participants 🎯
The trial is designed to explore a within-subject dose titration approach to reach anticipated therapeutic plasma concentrations of XEN-D0501 not previously investigated 📊
PILA PHARMA Founder and CSO Dorte X. Gram comments:
"The initiation and activation of the clinical site are important milestones as it concludes weeks of formal preparation following the regulatory approval of the trial, whereby numerous documents for compliant trial ex*****on are completed. The site initiation visit itself allows for the Sponsor, PILA, to meet the actual trial staff, share our story, and our vision for developing a TRPV1 antagonist as treatment of obesity and co-morbidities, a simple, accessible tablet solution with a differentiated safety profile, that could be a good fit to current market needs." 🌍
For more information, please find the press release in the comments!