Clinical Trials/NCT05934110

NCT05934110

Active, not recruiting

Phase 2

A 26-week, Double-blind, Randomized Study in Participants With Overweight or Obesity Investigating the Added Contribution of Acarbose in EMP16 on Efficacy, Safety and Tolerability

Empros Pharma AB3 sites in 1 country320 target enrollmentApril 18, 2023

ConditionsOverweight or Obesity

InterventionsMR orlistat 120 mg EMP16-120/40 Conventional orlistat 120 mg,Placebo EMP16-60/20

DrugsEMP16-120/40 MR orlistat 120 mg Conventional orlistat 120 mg,EMP16-60/20 Placebo

Overview

Phase: Phase 2
Intervention: MR orlistat 120 mg
Conditions: Overweight or Obesity
Sponsor: Empros Pharma AB
Enrollment: 320
Locations: 3
Primary Endpoint: Proportion of participants with ≥5% decrease in body weight at week 26 [Please note: This is an FDA required outcome, cannot use "change"]
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Detailed 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

Registry

clinicaltrials.gov

Start Date

April 18, 2023

End Date

March 15, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Empros Pharma AB

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Arms & Interventions

MR orlistat

MR orlistat 120 mg, 80 participants.

Intervention: MR orlistat 120 mg

EMP16-120/40

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

Intervention: EMP16-120/40

Conventional orlistat

Conventional orlistat 120 mg, 80 participants.

Intervention: Conventional orlistat 120 mg,

Conventional orlistat

Conventional orlistat 120 mg, 80 participants.

Intervention: Placebo

EMP16-60/20

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

Intervention: EMP16-60/20

EMP16-60/20

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

Intervention: Placebo

Placebo

Placebo, 40 participants

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: Baseline and week 26

Efficacy endpoints

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

Time Frame: Baseline and week 26

Efficacy endpoints

Secondary Outcomes

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 percentage body fat(Baseline and week 26)
Absolute change from baseline in waist circumference(Baseline and week 26)
Absolute change from baseline in Quality of life as measured by the questionnaire EQ-5D-5L (measured as one summative value)(Baseline and week 26)
Absolute change from baseline in body weight during the 26-weeks treatment period(Baseline to week 26)
Absolute change from baseline in self reported physical activity, where higher points are given for longer duration of moderate and intense physical activity(Baseline and week 26)
Absolute change from baseline in fasting total cholesterol(Baseline and week 26)
Absolute change from baseline in fasting high sensitivity C-reacting protein (hs-CRP)(Baseline and week 26)
Absolute change from baseline in homeostatic model assessment (HOMA) index(Baseline and week 26)
Absolute change from baseline in Fatty liver index (FLI)(Baseline and week 26)
Absolute change from baseline in body weight at week 26(Baseline and week 26)
Absolute change from baseline in sagittal diameter(Baseline and week 26)
Absolute change from baseline in fasting glucose(Baseline and week 26)
Absolute change from baseline in fasting low-density lipoprotein (LDL)(Baseline and week 26)
Absolute change from baseline in fasting Apolipoprotein A1 (ApoA1)(Baseline and week 26)
Absolute change from baseline in fasting high-density lipoprotein (HDL)(Baseline and week 26)
Absolute change from baseline in heart rate(Baseline and week 26)
Absolute change from baseline in fasting liver enzymes(Baseline and week 26)
Relative (%) change from baseline in body weight at week 26 (secondary and exploratory comparisons)(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 mass index (BMI) measured as weight (kg) divided by height (m) squared(Baseline and week 26)
Absolute change from baseline in Quality of life as measured by the questionnaire Rand-36 (9 different domains)(Baseline and week 26)
Absolute change from baseline in fasting Apolipoprotein B (ApoB)(Baseline and week 26)
Absolute change from baseline in fasting albumin(Baseline and week 26)
Number of withdrawals from study (total and gastrointestinal [GI] related)(Visit 1 until the end-of-study visit. Assessed at all nine visits (both outpatient and telephone visits))
Absolute change from baseline in self reported meal pattern. Short questionnaire where points are depending on adherence to the Nordic Nutrition recommendations(Baseline and week 26)
Absolute change from baseline in self reported sleep, where higher points are given for good sleep duration and good sleep quality(Baseline and week 26)
Absolute change from baseline in fasting insulin(Baseline and week 26)
Absolute change from baseline in Visceral adiposity index (VAI)(Baseline and week 26)
Tolerability, assessed by conventional adverse event (AE) reporting (with special focus on oily spotting and fecal incontinence)(IMP administration until the end-of-study visit. Assessed at all nine visits (both outpatient and telephone visits))
Absolute change from baseline in fasting hemoglobin A1c (HbA1c)(Baseline and week 26)
Absolute change from baseline in fasting triglycerides (TGs)(Baseline and week 26)
Absolute change from baseline in systolic and diastolic blood pressure(Baseline and week 26)