A Trial With EMP16 in Preparation for Late Phase Studies

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

NCT Number	NCT06993428
Lead Sponsor	Empros Pharma AB
Conditions	Overweight or Obese, Obesity and Overweight
Enrollment	39 participants
Start Date	2025-05-20
Primary Completion	2025-07-29 (estimated)
Study Completion	2025-07-29 (estimated)
Updated on ClinicalTrials.gov	2025-05-28