A Trial With EMP16 in Preparation for Late Phase Studies

NCT06993428 | Not Yet Recruiting Phase 2

• 2 other identifiers: EP-0052024-520122-11-00
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Overweight or Obese; Obesity and Overweight

Keywords

Obesity; Dose-escalation; EMP16; Overweight

Outcome Measures

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

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

Secondary Outcomes (2)

• Secondary outcome - GITE

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

• Secondary outcome - AEs

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

Study Arms (2)

EMP16 plus Vi-Siblin® S

EXPERIMENTAL

EMP16: Days 1 to 14: 1 capsule/day, Day 15 to 28, 1 capsule TID and Days 29 to 39: 2 capsules TID. The target dose of EMP16 will be 120 mg orlistat/40 mg acarbose. Vi-Siblin® S: 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).

Drug: EMP16-02 120 mg orlistat/40 mg acarbose; Dietary Supplement: Vi-Siblin® S

Coventional orlistat plus placebo dietary fibre supplementation

ACTIVE COMPARATOR

Conventional orlistat: Days 1 to 14: 1 capsule/day, Day 15 to 28, 1 capsule TID and Days 29 to 39: 2 capsules TID). Orlistat in its conventional form will be Alli® 60 mg. The target dose of Alli® will be 120 mg orlistat. Placebo dietary fibre supplement (Maltodextrin): 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).

Drug: Alli® 60 mg; Dietary Supplement: Maltodextrin

Interventions

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.

EMP16 plus Vi-Siblin® S

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.

Coventional orlistat plus placebo dietary fibre supplementation

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).

EMP16 plus Vi-Siblin® S

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).

Coventional orlistat plus placebo dietary fibre supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Adequate renal function: creatinine \<1.5 times the upper limit of normal (ULN).
• 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.

You may not qualify if:

• 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.
• 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.
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
• Any planned major surgery within the duration of the trial.
• 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.
• 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.
• Untreated high blood pressure (systolic blood pressure \>160 mmHg and diastolic blood pressure \>100 mmHg at the screening visit).

Sponsors & Collaborators

• Empros Pharma AB: lead

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Orlistat; maltodextrin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals

Study Officials

• Helena Litorp, MD, PhD

  CTC Clinical Trial Consultants AB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulf Holmbäck, PhD

CONTACT

+4670 173 00 41; ulf.holmback@emprospharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 28, 2025
• Study Start: May 20, 2025
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05