A Trial With EMP16 in Preparation for Late Phase Studies
Status:
NOT_YET_RECRUITING
Trial end date:
2025-07-29
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to explore the impact of dietary fibre supplement in the form of Vi-Siblin S (ispaghula seed coats), together with advice on proper healthy diet, on tolerability during dose-escalation of EMP16 in preparation for upcoming Phase III trials. It will also learn about the safety of EMP16. The main questions it aims to answer are:
* How does the combination of EMP16 plus Vi-Siblin S compare with the combination of conventional orlistat plus placebo dietary fibre supplementation on tolerability during dose-escalation
* What medical problems do participants have when taking EMP16 plus Vi-Siblin S? Researchers will compare EMP16 combined with Vi-Siblin S or conventional orlistat combined with placebo (a look-alike substance that contains no Vi-Siblin S) dietary fibre supplement.
Participants will:
* Take EMP16 combined with Vi-Siblin S or conventional orlistat combined with placebo every day for 39 days
* Come to one screening visit and then visit the clinic 6 times for checkups and tests
* Keep an electronic diary to record specific GI tolerability event (GITE) such as oily spotting, faecal incontinence (including flatulence with discharge) and diarrhoea