Biotech company Pila Pharma has conducted the first patient visit in part 1 of the clinical study PP-CT04 with the drug candidate XEN-D0501 for people with obesity. Six people were screened during the first day.
The study is randomized, double-blind and placebo-controlled and will evaluate safety, tolerability, pharmacokinetics and efficacy over 12 weeks. Part 1 comprises eight participants and has enhanced safety monitoring.
The dose is increased individually from 4 milligrams twice daily to a maximum of 16 milligrams twice daily. Part 2 may commence when all participants in part 1 have been treated for at least five weeks and the company’s internal safety committee has issued a positive recommendation.
