Study Exploring the Supportive Effect of Acarbose in Weight Management
- 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.
- Short title
- Study Exploring the Supportive Effect of Acarbose in Weight Management
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2024-03-15
- First posted
- 2023-07-06
- Registry last updated
- 2024-02-20
- Primary completion date
- 2023-11-21
- Start date
- 2023-04-18
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Empros Pharma AB
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05934110
- ClinicalTrials.gov ID
- NCT05934110
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masking description
- 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.
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Relative (%) change from baseline in body weight at week 26
Timeframe: Baseline and week 26
Efficacy endpoints
Proportion of participants with ≥5% decrease in body weight at week 26 [Please note: This is an FDA required outcome, cannot use "change"]
Timeframe: Baseline and week 26
Efficacy endpoints
Relative (%) change from baseline in body weight at week 26 (secondary and exploratory comparisons)
Timeframe: Baseline and week 26
Efficacy endpoints
Proportion of participants with ≥5% (secondary and exploratory comparisons) and ≥10% (all comparisons) decrease in body weight at week 18 and week 26
Timeframe: Baseline, week 18 and 26
Efficacy endpoints
Absolute change from baseline in body weight at week 26
Timeframe: Baseline and week 26
Efficacy endpoints
Relative (%) change from baseline in body weight during the 26-weeks treatment period
Timeframe: Baseline to week 26
Efficacy endpoints
Absolute change from baseline in body weight during the 26-weeks treatment period
Timeframe: Baseline to week 26
Efficacy endpoints
Absolute change from baseline in body mass index (BMI) measured as weight (kg) divided by height (m) squared
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in waist circumference
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in sagittal diameter
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in percentage body fat
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in Quality of life as measured by the questionnaire Rand-36 (9 different domains)
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in Quality of life as measured by the questionnaire EQ-5D-5L (measured as one summative value)
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in self reported meal pattern. Short questionnaire where points are depending on adherence to the Nordic Nutrition recommendations
Timeframe: Baseline and week 26
Efficacy endpoints.
Absolute change from baseline in self reported sleep, where higher points are given for good sleep duration and good sleep quality
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in self reported physical activity, where higher points are given for longer duration of moderate and intense physical activity
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in fasting hemoglobin A1c (HbA1c)
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in fasting glucose
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in fasting insulin
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in fasting total cholesterol
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in fasting high-density lipoprotein (HDL)
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in fasting low-density lipoprotein (LDL)
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in fasting triglycerides (TGs)
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in fasting Apolipoprotein A1 (ApoA1)
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in fasting Apolipoprotein B (ApoB)
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in fasting high sensitivity C-reacting protein (hs-CRP)
Timeframe: Baseline and week 26
Efficacy endpoints
Absolute change from baseline in fasting albumin
Timeframe: Baseline and week 26
Efficacy endpoints
And 8 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
-
Weight unstable (≥ 5% reported change during the previous 3 months) preceding screening and randomization.
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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.
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Type 2 diabetes treated with medication.
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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.
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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.
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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.
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Untreated high blood pressure (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg at the screening visit).
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Known hypersensitivity to any of the test substances.
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Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
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Excessive intake of alcohol, as judged by the Investigator.
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Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse.
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Positive screen for drugs of abuse, or positive screen for alcohol, at the screening visit (Visit 1).
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Any positive result at the screening visit (Visit 1) for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
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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.
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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.
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Investigator considers the potential participant unlikely to comply with study procedures, restrictions, and requirements.
- CTC EbbeparkLinköping, Sweden
- CTC KarolinskaSolna, Sweden
- Clinical Trial Consultants (CTC)Uppsala, Sweden
Other registry identifiers
- 2022-003320-40
Related records
Drugs (4)
Collaborators (1)
- CTC Clinical Trial Consultants AB