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Study Exploring the Supportive Effect of Acarbose in Weight Management

Primary Purpose

Overweight or Obesity

Status
Recruiting
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
EMP16-120/40
MR orlistat 120 mg
Conventional orlistat 120 mg,
EMP16-60/20
Placebo
Sponsored by
Empros Pharma AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight or Obesity focused on measuring Overweight, Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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. Untreated high blood pressure (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg at the screening visit). Known hypersensitivity to any of the test substances. Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma. Excessive intake of alcohol, as judged by the Investigator. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse. Positive screen for drugs of abuse, or positive screen for alcohol, at the screening visit (Visit 1). Any positive result at the screening visit (Visit 1) for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV). 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. 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. Investigator considers the potential participant unlikely to comply with study procedures, restrictions, and requirements.

Sites / Locations

  • CTC EbbeparkRecruiting
  • CTC KarolinskaRecruiting
  • Clinical Trial Consultants (CTC)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Placebo Comparator

Arm Label

EMP16-120/40

MR orlistat

Conventional orlistat

EMP16-60/20

Placebo

Arm Description

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

MR orlistat 120 mg, 80 participants.

Conventional orlistat 120 mg, 80 participants.

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

Placebo, 40 participants

Outcomes

Primary Outcome Measures

Relative (%) change from baseline in body weight at 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"]
Efficacy endpoints

Secondary Outcome Measures

Relative (%) change from baseline in body weight at week 26 (secondary and exploratory comparisons)
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
Efficacy endpoints
Absolute change from baseline in body weight at week 26
Efficacy endpoints
Relative (%) change from baseline in body weight during the 26-weeks treatment period
Efficacy endpoints
Absolute change from baseline in body weight during the 26-weeks treatment period
Efficacy endpoints
Absolute change from baseline in body mass index (BMI) measured as weight (kg) divided by height (m) squared
Efficacy endpoints
Absolute change from baseline in waist circumference
Efficacy endpoints
Absolute change from baseline in sagittal diameter
Efficacy endpoints
Absolute change from baseline in percentage body fat
Efficacy endpoints
Absolute change from baseline in Quality of life as measured by the questionnaire Rand-36 (9 different domains)
Efficacy endpoints
Absolute change from baseline in Quality of life as measured by the questionnaire EQ-5D-5L (measured as one summative value)
Efficacy endpoints
Absolute change from baseline in self reported meal pattern. Short questionnaire where points are depending on adherence to the Nordic Nutrition recommendations
Efficacy endpoints.
Absolute change from baseline in self reported sleep, where higher points are given for good sleep duration and good sleep quality
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
Efficacy endpoints
Absolute change from baseline in fasting hemoglobin A1c (HbA1c)
Efficacy endpoints
Absolute change from baseline in fasting glucose
Efficacy endpoints
Absolute change from baseline in fasting insulin
Efficacy endpoints
Absolute change from baseline in fasting total cholesterol
Efficacy endpoints
Absolute change from baseline in fasting high-density lipoprotein (HDL)
Efficacy endpoints
Absolute change from baseline in fasting low-density lipoprotein (LDL)
Efficacy endpoints
Absolute change from baseline in fasting triglycerides (TGs)
Efficacy endpoints
Absolute change from baseline in fasting Apolipoprotein A1 (ApoA1)
Efficacy endpoints
Absolute change from baseline in fasting Apolipoprotein B (ApoB)
Efficacy endpoints
Absolute change from baseline in fasting high sensitivity C-reacting protein (hs-CRP)
Efficacy endpoints
Absolute change from baseline in fasting albumin
Efficacy endpoints
Absolute change from baseline in homeostatic model assessment (HOMA) index
Efficacy endpoints
Absolute change from baseline in Visceral adiposity index (VAI)
Efficacy endpoints VAI Males = (WC/(39.38+(1.88*BMI)))*(TG/1.03)*(1.31/HDL) VAI Females = (WC/(36.58+(1.89*BMI)))*(TG/0.81)*(1.52/HDL)
Absolute change from baseline in Fatty liver index (FLI)
Efficacy endpoints. Measured as FLI = 100*e to the power of y /(1+e to the power of y) y= 0.953*ln(TG)+0,139*BMI+0.718*ln(GGT)+0.053*WC-15.3745
Absolute change from baseline in systolic and diastolic blood pressure
Efficacy endpoints
Absolute change from baseline in heart rate
Efficacy endpoints
Tolerability, assessed by conventional adverse event (AE) reporting (with special focus on oily spotting and fecal incontinence)
Safety & tolerability endpoints
Number of withdrawals from study (total and gastrointestinal [GI] related)
Safety & tolerability endpoints
Absolute change from baseline in fasting liver enzymes
Safety & tolerability endpoints (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and gamma-glutamyl transferase)

Full Information

First Posted
May 29, 2023
Last Updated
June 28, 2023
Sponsor
Empros Pharma AB
Collaborators
CTC Clinical Trial Consultants AB
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1. Study Identification

Unique Protocol Identification Number
NCT05934110
Brief 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
December 11, 2023 (Anticipated)
Study Completion Date
December 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Empros Pharma AB
Collaborators
CTC Clinical Trial Consultants AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight or Obesity
Keywords
Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
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.
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EMP16-120/40
Arm Type
Experimental
Arm Description
EMP16 120 mg orlistat/40 mg acarbose (referred to as EMP16-120/40), 80 participants.
Arm Title
MR orlistat
Arm Type
Active Comparator
Arm Description
MR orlistat 120 mg, 80 participants.
Arm Title
Conventional orlistat
Arm Type
Active Comparator
Arm Description
Conventional orlistat 120 mg, 80 participants.
Arm Title
EMP16-60/20
Arm Type
Experimental
Arm Description
EMP16 60 mg orlistat/20 mg acarbose (referred to as EMP16-60/20), 40 participants.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 40 participants
Intervention Type
Drug
Intervention Name(s)
EMP16-120/40
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
MR orlistat 120 mg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Conventional orlistat 120 mg,
Other Intervention Name(s)
Xenical
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
EMP16-60/20
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosage: week 1-2: Placebo (1 capsule per day), week 3-4: Placebo (1 capsule TID), week 5-26: Placebo (2 capsules TID)
Primary Outcome Measure Information:
Title
Relative (%) change from baseline in body weight at week 26
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Proportion of participants with ≥5% decrease in body weight at week 26 [Please note: This is an FDA required outcome, cannot use "change"]
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Secondary Outcome Measure Information:
Title
Relative (%) change from baseline in body weight at week 26 (secondary and exploratory comparisons)
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Proportion of participants with ≥5% (secondary and exploratory comparisons) and ≥10% (all comparisons) decrease in body weight at week 18 and week 26
Description
Efficacy endpoints
Time Frame
Baseline, week 18 and 26
Title
Absolute change from baseline in body weight at week 26
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Relative (%) change from baseline in body weight during the 26-weeks treatment period
Description
Efficacy endpoints
Time Frame
Baseline to week 26
Title
Absolute change from baseline in body weight during the 26-weeks treatment period
Description
Efficacy endpoints
Time Frame
Baseline to week 26
Title
Absolute change from baseline in body mass index (BMI) measured as weight (kg) divided by height (m) squared
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in waist circumference
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in sagittal diameter
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in percentage body fat
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in Quality of life as measured by the questionnaire Rand-36 (9 different domains)
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in Quality of life as measured by the questionnaire EQ-5D-5L (measured as one summative value)
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in self reported meal pattern. Short questionnaire where points are depending on adherence to the Nordic Nutrition recommendations
Description
Efficacy endpoints.
Time Frame
Baseline and week 26
Title
Absolute change from baseline in self reported sleep, where higher points are given for good sleep duration and good sleep quality
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in self reported physical activity, where higher points are given for longer duration of moderate and intense physical activity
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in fasting hemoglobin A1c (HbA1c)
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in fasting glucose
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in fasting insulin
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in fasting total cholesterol
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in fasting high-density lipoprotein (HDL)
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in fasting low-density lipoprotein (LDL)
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in fasting triglycerides (TGs)
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in fasting Apolipoprotein A1 (ApoA1)
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in fasting Apolipoprotein B (ApoB)
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in fasting high sensitivity C-reacting protein (hs-CRP)
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in fasting albumin
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in homeostatic model assessment (HOMA) index
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in Visceral adiposity index (VAI)
Description
Efficacy endpoints VAI Males = (WC/(39.38+(1.88*BMI)))*(TG/1.03)*(1.31/HDL) VAI Females = (WC/(36.58+(1.89*BMI)))*(TG/0.81)*(1.52/HDL)
Time Frame
Baseline and week 26
Title
Absolute change from baseline in Fatty liver index (FLI)
Description
Efficacy endpoints. Measured as FLI = 100*e to the power of y /(1+e to the power of y) y= 0.953*ln(TG)+0,139*BMI+0.718*ln(GGT)+0.053*WC-15.3745
Time Frame
Baseline and week 26
Title
Absolute change from baseline in systolic and diastolic blood pressure
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Absolute change from baseline in heart rate
Description
Efficacy endpoints
Time Frame
Baseline and week 26
Title
Tolerability, assessed by conventional adverse event (AE) reporting (with special focus on oily spotting and fecal incontinence)
Description
Safety & tolerability endpoints
Time Frame
IMP administration until the end-of-study visit. Assessed at all nine visits (both outpatient and telephone visits)
Title
Number of withdrawals from study (total and gastrointestinal [GI] related)
Description
Safety & tolerability endpoints
Time Frame
Visit 1 until the end-of-study visit. Assessed at all nine visits (both outpatient and telephone visits)
Title
Absolute change from baseline in fasting liver enzymes
Description
Safety & tolerability endpoints (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and gamma-glutamyl transferase)
Time Frame
Baseline and week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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. Untreated high blood pressure (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg at the screening visit). Known hypersensitivity to any of the test substances. Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma. Excessive intake of alcohol, as judged by the Investigator. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse. Positive screen for drugs of abuse, or positive screen for alcohol, at the screening visit (Visit 1). Any positive result at the screening visit (Visit 1) for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV). 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. 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. Investigator considers the potential participant unlikely to comply with study procedures, restrictions, and requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulf Holmbäck, PhD
Phone
+46 (0) 70 173 00 41
Email
ulf.holmback@emprospharma.com
Facility Information:
Facility Name
CTC Ebbepark
City
Linköping
ZIP/Postal Code
SE-582 13
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Litorp, MD, PhD
Facility Name
CTC Karolinska
City
Solna
ZIP/Postal Code
SE-171 64
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Litorp, MD, PhD
Facility Name
Clinical Trial Consultants (CTC)
City
Uppsala,
ZIP/Postal Code
SE-752 37
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Litorp, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Study Exploring the Supportive Effect of Acarbose in Weight Management

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