A Trial With EMP16 in Preparation for Late Phase Studies

Empros Pharma AB is developing EMP16, a modified release (MR), fixed dose combination (FDC) of orlistat, a gastrointestinal (GI) lipase inhibitor, and acarbose, an intestinal alpha-glucosidase inhibitor, for chronic weight management.

The main purpose of the 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. Consumption of Vi-Siblin® S together with EMP16 is assumed to reduce prevalence and intensity of GI-related adverse events (AEs), and may also add some extra health benefits, such as further decrease in weight and blood lipids.

This Phase II, randomised, single-blinded trial will be conducted in participants with obesity who have experienced GI side-effects after treatment with EMP16 or conventional orlistat.

Approximately 62 participants are planned to be screened to achieve 39 enrolled participants.

Participants will be randomised 1:2 to EMP16 combined with Vi-Siblin® S (n=13) or conventional orlistat combined with placebo dietary fibre supplement (n=26).

Prior to any trial assessments, participants will be asked to provide signed informed consent to participate in the trial. The screening visit (Visit 1) will be followed by 6 outpatient visits to the research clinic (Visit 2 to Visit 7). The 39-day treatment period starts with an outpatient visit (Day 1, Visit 2). After randomisation, anthropometry assessments, and collection of fasting blood samples, participants are given the first dose of EMP16/ conventional orlistat during breakfast, together with Vi-Siblin® S or placebo dietary fibre supplement. Here, participants will also be instructed in how to prepare Vi-Siblin® S or placebo dietary fibre supplement.

Participants will be instructed in how to record GITE: oily spotting, faecal incontinence (including flatulence with discharge) and diarrhoea in an electronic diary (eDiary), and any events that have occurred during the 3 days prior to Visit 2 are filled in (baseline GITE). Prior to leaving the clinic, participants will be provided with EMP16/conventional orlistat and Vi-Siblin® S/placebo dietary fibre supplement for the coming weeks and written lifestyle information. Participants will also receive online advice on proper healthy diet and how access a recipe database. EMP16/ conventional orlistat will be self-administered at home between Day 2 and Day 39 according to a dose-escalation schedule (Days 1 to 14: 1 capsule/day, Day 15 to 28, 1 capsule TID and Days 29 to 39: 2 capsules TID). Vi-Siblin® S /placebo dietary fibre supplement will also be taken according to a dose-escalation schedule, with 20 ml (corresponding to approximately 8 g) in the morning during Days 1 to 14; then 20 ml in the morning and evening the rest of the trial (total daily dose 16 g).