A Trial With EMP16 in Preparation for Late Phase Studies

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

Timeline

Start

2025-05-20

Primary completion

2025-07-29

Completion

2025-07-29

Drugs

Indications