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A Trial With EMP16 in Preparation for Late Phase Studies

ConditionsOverweight or ObeseObesity and Overweight
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmpros Pharma AB

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Willing and able to give written informed consent for participation in the trial.

Have experienced GI tolerability issues (defined as the occurrence of oily spotting, faecal incontinence and/or moderate/severe diarrhoea as reported by the participant) in previous trials using EMP16 or have experienced corresponding GI tolerability issues using conventional orlistat, either in clinical trials or regular clinical treatment of obesity.

Males or females aged ≥18 years.

At the time of the screening visit, BMI ≥ 30 or ≥ 27 kg/m² in the presence of other risk factors based on participant interview e.g., hypertension (either or not treated with antihypertensive agents), glucose dysregulation (defined as elevated fasting glucose ≥6.1 mmol/L or HbA1c >42mmol/mol), T2DM that is treated with lifestyle changes (no medication allowed), and/or dyslipidaemia (either or not treated with antihyperlipidemic agents). If indicated, plasma/serum total cholesterol, LDL, high-density lipoprotein (HDL), and/or triglycerides (TG) can be measured to verify eligibility as judged by the Investigator.

Disqualifiers

Regular use of any obesity medication within 1 month prior to Day 1 at the discretion of the Investigator.

Participants who are pregnant, who are currently breastfeeding, who intend to become pregnant within the period of the trial, or who gave birth within the 6 months preceding the screening visit.

T2DM treated with medication.

GI problems/diseases, e.g. inflammatory bowel diseases and irritable bowel syndrome (IBS).

Trial design

Design model

Parallel

Treatments tested in this trial

  • EMP16-02 120 mg orlistat/40 mg acarbose

    Drug

    Days 1 to 14: 1 capsule/day, Day 15 to 28, 1 capsule TID and Days 29 to 39: 2 capsules TID).Target dose EMP16: 120 mg orlistat/40 mg acarbose.

  • Alli® 60 mg

    Drug

    Days 1 to 14: 1 capsule/day, Day 15 to 28, 1 capsule TID and Days 29 to 39: 2 capsules TID).Target dose EMP16: 120 mg orlistat/40 mg acarbose.

  • Vi-Siblin® S

    Dietary supplement

    Vi-Siblin® S will 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).

  • Maltodextrin

    Dietary supplement

    Maltodextrin will 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).

Treatment groups

39 Participants
are divided into 2 treatment groups
Group A: EMP16 plus Vi-Siblin® SExperimental treatment 2 interventions
Group B: Coventional orlistat plus placebo dietary fibre supplementationActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Primary objective

The difference in total GITE score (oily spotting, faecal incontinence \[including flatulence with discharge\] and diarrhoea) between EMP16 combined with Vi-Siblin® S and conventional orlistat combined with placebo dietary fibre supplement

Time frame
From start of treatment (day 1) until last visit day 40.

Secondary outcomes

1

Secondary outcome - GITE

Presence and participant rated severity of the individual GITE components

Time frame
From start of treatment (day 1) until last visit day 40.
2

Secondary outcome - AEs

Presence and Investigator-rated severity of GI-related AEs

Time frame
From start of treatment (day 1) until last visit day 40.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Empros Pharma AB

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: