A Trial With EMP16 in Preparation for Late Phase Studies

Prior treatment

• Regular use of any obesity medication within 1 month prior to Day 1 at the discretion of the Investigator.
• 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 planned major surgery within the duration of the trial.
• 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.
• Positive screening result for drugs of abuse or alcohol at the screening visit.
• Plasma donation within 1 month prior to screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening.
• 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.

Other illness

• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
• Known hypersensitivity to any of the test substances.
• Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
• History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
• Presence or history of drug abuse and/or use of anabolic steroids, as judged by the Investigator.

Lab values

• 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.
• Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).

Other

• 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.
• Untreated high blood pressure (systolic blood pressure \>160 mmHg and diastolic blood pressure \>100 mmHg at the screening visit).
• The Investigator considers the participant unlikely to comply with trial procedures, restrictions and requirements.

• 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.