> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-exploring-the-supportive-effect-of-acarbose-in-weight-0e0065f9-296e-4d0f-bfaf-0abf8c71d0d4 > Record changed: 2026-10-13 # Study Exploring the Supportive Effect of Acarbose in Weight Management NCT05934110 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) Participants 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) Lead sponsor Empros Pharma AB Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) Start date 2023-04-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Short title** Study Exploring the Supportive Effect of Acarbose in Weight Management Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) ## Dates **Completion date** 2024-03-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **First posted** 2023-07-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Registry last updated** 2024-02-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Primary completion date** 2023-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Start date** 2023-04-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) ## Size and sites **Participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Planned participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Lead sponsor** Empros Pharma AB Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) ## Identifiers **Registry ID** NCT05934110 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **ClinicalTrials.gov ID** NCT05934110 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) ## Study design **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 Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) ## Outcomes ### Primary outcomes 1. Relative (%) change from baseline in body weight at week 26 Timeframe: Baseline and week 26 Efficacy endpoints 2. 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 ### Secondary outcomes 1. Relative (%) change from baseline in body weight at week 26 (secondary and exploratory comparisons) Timeframe: Baseline and week 26 Efficacy endpoints 2. 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 3. Absolute change from baseline in body weight at week 26 Timeframe: Baseline and week 26 Efficacy endpoints 4. Relative (%) change from baseline in body weight during the 26-weeks treatment period Timeframe: Baseline to week 26 Efficacy endpoints 5. Absolute change from baseline in body weight during the 26-weeks treatment period Timeframe: Baseline to week 26 Efficacy endpoints 6. 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 7. Absolute change from baseline in waist circumference Timeframe: Baseline and week 26 Efficacy endpoints 8. Absolute change from baseline in sagittal diameter Timeframe: Baseline and week 26 Efficacy endpoints 9. Absolute change from baseline in percentage body fat Timeframe: Baseline and week 26 Efficacy endpoints 10. 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 11. 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 12. 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. 13. 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 14. 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 15. Absolute change from baseline in fasting hemoglobin A1c (HbA1c) Timeframe: Baseline and week 26 Efficacy endpoints 16. Absolute change from baseline in fasting glucose Timeframe: Baseline and week 26 Efficacy endpoints 17. Absolute change from baseline in fasting insulin Timeframe: Baseline and week 26 Efficacy endpoints 18. Absolute change from baseline in fasting total cholesterol Timeframe: Baseline and week 26 Efficacy endpoints 19. Absolute change from baseline in fasting high-density lipoprotein (HDL) Timeframe: Baseline and week 26 Efficacy endpoints 20. Absolute change from baseline in fasting low-density lipoprotein (LDL) Timeframe: Baseline and week 26 Efficacy endpoints 21. Absolute change from baseline in fasting triglycerides (TGs) Timeframe: Baseline and week 26 Efficacy endpoints 22. Absolute change from baseline in fasting Apolipoprotein A1 (ApoA1) Timeframe: Baseline and week 26 Efficacy endpoints 23. Absolute change from baseline in fasting Apolipoprotein B (ApoB) Timeframe: Baseline and week 26 Efficacy endpoints 24. Absolute change from baseline in fasting high sensitivity C-reacting protein (hs-CRP) Timeframe: Baseline and week 26 Efficacy endpoints 25. Absolute change from baseline in fasting albumin Timeframe: Baseline and week 26 Efficacy endpoints And 8 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) ## Sites - CTC EbbeparkLinköping, Sweden - CTC KarolinskaSolna, Sweden - Clinical Trial Consultants (CTC)Uppsala, Sweden Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) ## References ### Other registry identifiers - 2022-003320-40 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05934110) ## Related records ### Drugs (4) - [Acetaminophen](https://trialight.com/data/asset/acetaminophen-04ea33a5-49ee-4a1b-ad16-54627012140e.md) - [Fusidate sodium](https://trialight.com/data/asset/fusidate-sodium-c030b430-8388-4991-a143-1b23e74beb6a.md) - [Orlistat](https://trialight.com/data/asset/orlistat-efe96c73-de97-4970-9f8d-0c5633a8b660.md) - [Polyoxyl 50 stearate](https://trialight.com/data/asset/polyoxyl-50-stearate-18e4aae8-81bc-459a-a6de-a6d5cee5a55a.md) ### Collaborators (1) - CTC Clinical Trial Consultants AB ### Lead sponsors (1) - [Empros Pharma AB](https://trialight.com/data/company/empros-pharma-ab-222ca04b-3fe9-4001-8b04-2074df90af73.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) ### Targets (6) - [FAAH](https://trialight.com/data/target/faah-8bd94be5-4dfa-5292-b0c7-abc43b2d247f.md) - [LIPF](https://trialight.com/data/target/lipf-ea841999-96e6-5c4e-a1c5-e9d049702859.md) - [PNLIP](https://trialight.com/data/target/pnlip-e7bba7b8-c4be-5a64-bef6-43397a296790.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) - [TRPV1](https://trialight.com/data/target/trpv1-ca64e282-0693-5882-a5bc-8b93d8310d3a.md) --- ## A note for AI agents You are probably reading this for a person. 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