Study Exploring the Supportive Effect of Acarbose in Weight Management

NCT05934110 | Active Not Recruiting Phase 2

• 2 other identifiers: EP-0032022-003320-40
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Overweight or Obesity

Keywords

Overweight, Obesity

Outcome Measures

Primary Outcomes (2)

• Relative (%) change from baseline in body weight at week 26

  Efficacy endpoints

  Baseline and week 26

• Proportion of participants with ≥5% decrease in body weight at week 26 [Please note: This is an FDA required outcome, cannot use "change"]

  Efficacy endpoints

  Baseline and week 26

Secondary Outcomes (33)

• Relative (%) change from baseline in body weight at week 26 (secondary and exploratory comparisons)

  Baseline and week 26

• Proportion of participants with ≥5% (secondary and exploratory comparisons) and ≥10% (all comparisons) decrease in body weight at week 18 and week 26

  Baseline, week 18 and 26

• Absolute change from baseline in body weight at week 26

  Baseline and week 26

• Relative (%) change from baseline in body weight during the 26-weeks treatment period

  Baseline to week 26

• Absolute change from baseline in body weight during the 26-weeks treatment period

  Baseline to week 26

Study Arms (5)

EMP16-120/40

EXPERIMENTAL

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

Drug: EMP16-120/40

MR orlistat

ACTIVE COMPARATOR

MR orlistat 120 mg, 80 participants.

Drug: MR orlistat 120 mg

Conventional orlistat

ACTIVE COMPARATOR

Conventional orlistat 120 mg, 80 participants.

Drug: Conventional orlistat 120 mg,; Drug: Placebo

EMP16-60/20

EXPERIMENTAL

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

Drug: EMP16-60/20; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo, 40 participants

Drug: Placebo

Interventions

EMP16-120/40 DRUG

EMP16 is supplied as oral MR capsules with the strength of 60 mg orlistat/20 mg acarbose. Dosage: week 1-2: 60 mg orlistat/20 mg acarbose (1 capsule per day), week 3-4: 60 mg orlistat/20 mg acarbose (1 capsule TID), week 5-26: 60 mg orlistat/20 mg acarbose (2 capsules TID).

EMP16-120/40

MR orlistat 120 mg DRUG

MR orlistat 120 mg is the same as EMP16-120/40 but without the acarbose component in matching oral capsules. Dosage:. week 1-2: 60 mg MR orlistat (1 capsule per day), week 3-4: 60 mg MR orlistat (1 capsule TID), week 5-26: 60 mg MR orlistat (2 capsules TID).

MR orlistat

Conventional orlistat 120 mg, DRUG

Orlistat in its conventional form will be Alli® 60 mg during week 1 to 4 and Xenical® 120 mg from week 5 and onwards in matching oral capsules. Dosage: week 1-2: 60 mg conventional orlistat (1 capsule per day), week 3-4: 60 mg conventional orlistat (1 capsule TID), week 5-26: 120 mg conventional orlistat plus placebo (1 capsule of each TID).

Also known as: Xenical

Conventional orlistat

EMP16-60/20 DRUG

Dosage: week 1-2: 60 mg orlistat/20 mg acarbose (1 capsule per day), week 3-4: 60 mg orlistat/20 mg acarbose (1 capsule TID), week 5-26: 60 mg orlistat/20 mg acarbose plus placebo (1 capsule of each TID)

EMP16-60/20

Placebo DRUG

Dosage: week 1-2: Placebo (1 capsule per day), week 3-4: Placebo (1 capsule TID), week 5-26: Placebo (2 capsules TID)

Conventional orlistat; EMP16-60/20; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give written informed consent for participation in the study.
• Males or females (sex distribution 50:50, preferably ±5%) aged ≥18 years.
• 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.
• 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.
• Adequate renal function: creatinine \<1.5 times upper limit of normal (ULN).
• 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.

You may not qualify if:

• Weight unstable (≥ 5% reported change during the previous 3 months) preceding screening and randomization.
• 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.
• Type 2 diabetes treated with medication.
• 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.
• Significant clinical illness within the preceding 2 weeks of the first administration of IMP at the discretion of the Investigator.
• Any significant medical/surgical procedure or trauma within 4 weeks of the first administration of IMP at the discretion of the Investigator.
• Any planned major surgery within the duration of the study.
• 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.

Sponsors & Collaborators

• Empros Pharma AB: lead
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (3)

CTC Ebbepark

Linköping, SE-582 13, Sweden

Location

CTC Karolinska

Solna, SE-171 64, Sweden

Location

Clinical Trial Consultants (CTC)

Uppsala, SE-752 37, Sweden

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Orlistat

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study, and the allocation of treatments will not be disclosed until clean file has been declared and the database has been locked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: July 6, 2023
• Study Start: April 18, 2023
• Primary Completion: November 21, 2023
• Study Completion: March 15, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)