Study Exploring the Supportive Effect of Acarbose in Weight Management

Empros Pharma

Status and phase: Active, not recruiting; Phase 2

Conditions: Overweight or Obesity

Treatments: Drug: Placebo; Drug: Conventional orlistat 120 mg,; Drug: MR orlistat 120 mg; Drug: EMP16-60/20; Drug: EMP16-120/40

Study type: Interventional

Funder types: Industry

Identifiers

NCT05934110

2022-003320-40 (EudraCT Number)

EP-003

Details and patient eligibility

About

This is a randomized, double-blind study in participants with overweight or obesity in which the effect of acarbose and the impact of dose on efficacy, safety and tolerability is investigated by comparing the EMP16 combination product with modified release (MR) orlistat, orlistat in its conventional dosage form and placebo.

Full description

The study will be conducted at 3 research sites in Sweden. A total of 320 randomized patients are expected to participate in the study for approximately 31 weeks, including a screening period of up to 5 weeks and a 26-weeks treatment period.

EMP16 is indicated for people with obesity with an initial BMI ≥ 30 kg/m² or ≥ 27 kg/m² in the presence of other risk factors (e.g., hypertension, glucose dysregulation and T2DM, and/or dyslipidemia).

Participants will be randomized to either of 5 arms:

• EMP16-120/40, 80 participants
• MR orlistat 120 mg, 80 participants
• Conventional orlistat 120 mg, 80 participants
• EMP16-60/20, 40 participants
• Placebo, 40 participants

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Willing and able to give written informed consent for participation in the study.
2. Males or females (sex distribution 50:50, preferably ±5%) aged ≥18 years.
3. 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), Type 2 Ddabetes that is treated with lifestyle changes (no medication allowed), and/or dyslipidemia (either or not treated with antihyperlipidemic agents). If indicated, plasma/serum total cholesterol, LDL, HDL, and/or TGs can be measured to verify eligibility as judged by the Investigator.
4. No clinically significant abnormalities regarding physical examination, vital signs, ECG, and laboratory values at the time of the screening visit, as judged by the Investigator.
5. Adequate renal function: creatinine <1.5 times upper limit of normal (ULN).
6. Adequate hepatic function: aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase <2.5 times upper level of normal (ULN) and bilirubin <1.5 times ULN.

Exclusion criteria

1. Weight unstable (≥ 5% reported change during the previous 3 months) preceding screening and randomization.

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

3. Type 2 diabetes treated with medication.

4. History or presence of any clinically significant disease, disorder, or history of surgery which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study including but not limited to:

   • GI problems/diseases, e.g., diseases that affect intestinal absorption and peristalsis such as inflammatory bowel diseases, irritable bowel syndrome (IBS) and Hirschsprung's disease
   • Cholestasis
   • Chronical malabsorption syndrome
   • 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.

   Potential participants with well-treated chronic diseases (e.g., celiac disease and lactose intolerance) may be included in the study at the discretion of the Investigator.

5. Significant clinical illness within the preceding 2 weeks of the first administration of IMP at the discretion of the Investigator.

6. Any significant medical/surgical procedure or trauma within 4 weeks of the first administration of IMP at the discretion of the Investigator.

7. Any planned major surgery within the duration of the study.

8. 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.

9. 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.

10. Untreated high blood pressure (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg at the screening visit).

11. Known hypersensitivity to any of the test substances.

12. Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.

13. Excessive intake of alcohol, as judged by the Investigator.

14. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse.

15. Positive screen for drugs of abuse, or positive screen for alcohol, at the screening visit (Visit 1).

16. Any positive result at the screening visit (Visit 1) for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).

17. Plasma donation within 1 month of the screening visit (Visit 1) or any blood donation (or corresponding blood loss) during the 3 months prior to the screening visit.

18. Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of IMP in this study. Participants consented and screened but not dosed in previous studies are not excluded.

19. Investigator considers the potential participant unlikely to comply with study procedures, restrictions, and requirements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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320 participants in 5 patient groups, including a placebo group

EMP16-120/40

Experimental group

Description:

EMP16 120 mg orlistat/40 mg acarbose (referred to as EMP16-120/40), 80 participants.

Treatment:

Drug: EMP16-120/40

MR orlistat

Active Comparator group

Description:

MR orlistat 120 mg, 80 participants.

Treatment:

Drug: MR orlistat 120 mg

Conventional orlistat

Active Comparator group

Description:

Conventional orlistat 120 mg, 80 participants.

Treatment:

Drug: Placebo

Drug: Conventional orlistat 120 mg,

EMP16-60/20

Experimental group

Description:

EMP16 60 mg orlistat/20 mg acarbose (referred to as EMP16-60/20), 40 participants.

Treatment:

Drug: Placebo

Drug: EMP16-60/20

Placebo

Placebo Comparator group

Description:

Placebo, 40 participants

Treatment:

Drug: Placebo