A Phase 1 Study to Evaluate EMP22 PD and EMP16 PK Versus Xenical® in Healthy Volunteers
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
This Phase I, active-controlled, randomised trial will be conducted in 2 parts. Part I aims
to confirm the PD equivalence of EMP22 and Xenical® based on percent fecal fat excretion at
steady state. EMP22 (also referred to as MR orlistat) has the same MR properties as EMP16 but
lacks the acarbose component. Part II will explore the PK properties of EMP16 alone and vs.
Xenical®. Part I will be conducted in a single-blind, cross-over fashion while Part II will
have an open-label, fixed-sequence design. Healthy volunteers will be recruited to the trial.