A PilOt dose-escalation trial with EMP16 in preparation for Phase III – the POEM trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Empros Pharma AB

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

7 May 2025 → 30 Sep 2025

Decision date (initial)

2025-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To compare the combination of EMP16 plus Vi-Siblin® S with the combination of conventional orlistat plus placebo dietary fibre supplementation on tolerability during dose-escalation

Secondary objectives 2

1. To explore the impact of Vi-Siblin® S on tolerability based on specific GITE components during dose-escalation in EMP16 in comparison with the active control conventional orlistat combined with placebo dietary fibre supplement
2. To explore the impact of Vi-Siblin® S on GI-related AEs during dose-escalation in EMP16 in comparison with the active control conventional orlistat combined with placebo dietary fibre supplement

Conditions and MedDRA coding

Obesity

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Willing and able to give written informed consent for participation in the trial.
2. 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.
3. Males or females aged ≥18 years.
4. 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.
5. No clinically significant abnormalities regarding physical examination, vital signs, electrocardiogram (ECG), and laboratory values at the time of the screening visit, as judged by the Investigator.
6. Adequate renal function: creatinine <1.5 times the upper limit of normal (ULN).
7. Adequate hepatic function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) <2.5 times ULN and bilirubin <1.5 times ULN.

Exclusion criteria 18

1. Regular use of any obesity medication within 1 month prior to Day 1 at the discretion of the Investigator.
2. Participants who are pregnant, who are currently breastfeeding, who intend to become pregnant within the period of the trial (see Section 9.6.1 General restrictions), or who gave birth within the 6 months preceding the screening visit.
3. T2DM treated with medication.
4. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial or influence the results or the participant’s ability to participate in the trial including but not limited to: • GI problems/diseases, e.g. inflammatory bowel diseases and irritable bowel syndrome (IBS). • Cholestasis. • Chronical malabsorption syndrome. • History of severe allergic, cardiac or hepatic disease. • Previous GI surgery that might influence GI function significantly, such as previous bariatric surgery, and previous gallbladder surgery as judged by the Investigator. • Vitamin B12 deficiency or other signs of achlorhydria. Potential participants with well-treated chronic diseases (e.g., celiac disease and lactose intolerance) may be included in the trial at the discretion of the Investigator.
5. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
6. Any planned major surgery within the duration of the trial.
7. Any use of drugs altering glucose metabolism and drugs used for diabetes (A10A and A10B) or drugs that are affected by, or that affect, orlistat and acarbose, within 2 weeks prior to the first administration of IMP.
8. Regular use of prescribed or non-prescribed medication within 2 weeks prior to the first administration of IMP as judged by the Investigator. Patients who are on stable treatment with anti-depressants (e.g., selective serotonin re-uptake inhibitors [SSRI]) for at least 2 months can be included at the discretion of the Investigator.
9. Untreated high blood pressure (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg at the screening visit).
10. Known hypersensitivity to any of the test substances.
11. Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
12. History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
13. Presence or history of drug abuse and/or use of anabolic steroids, as judged by the Investigator.
14. Positive screening result for drugs of abuse or alcohol at the screening visit.
15. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).
16. Plasma donation within 1 month prior to screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening.
17. Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical trial that included drug treatment within 3 months of the first administration of IMP in this trial. Participants who consented and screened but were not dosed in previous studies are not excluded.
18. The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The difference in total GITE1 score between EMP16 combined with Vi-Siblin® S and conventional orlistat combined with placebo dietary fibre supplement

Secondary endpoints 2

1. Presence and participant rated severity of the individual GITE components: •oily spotting •faecal incontinence (including flatulence with discharge) •diarrhoea
2. Presence and Investigator-rated severity of GI-related AEs. all events jointly and individually, i.e. for: •oily spotting •faecal incontinence (including flatulence with discharge) •diarrhoea

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Empros Pharma AB

Sponsor organisation

Empros Pharma AB

Address

Nanna Svartz Vag 4

City

Solna

Postcode

171 65

Country

Sweden

Scientific contact point

Organisation

Empros Pharma AB

Contact name

Ulf Holmbäck

Public contact point

Organisation

Empros Pharma AB

Contact name

Ulf Holmbäck

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications