Clinical Trials Register

Summary
EudraCT Number:	2016-001055-50
Sponsor's Protocol Code Number:	EP-001
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-05-31
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Sweden - MPA

A.2

EudraCT number

2016-001055-50

A.3

Full title of the trial

A, single center, controlled, multiple dose, randomized study during two weeks, investigating the effect of the test formulation on efficacy, safety and markers for appetite regulation, glucose and lipid absorption and metabolism and body composition, in comparision with Xenical.

En singel-center, kontrollerad, randomiserad, multipel-dos studie över två veckor för att studera effekten av test-läkemedel och referensläkemedel, med avseende på säkerhet, tolerabilitet, effekt, biomarkörer för aptitreglering, glukos och lipid-absorbtion och -metabolism samt kroppskonstutition, i jämförelse med Xenical.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study conducted to assess effect and safety of a new pharmaceutical compared to Xenical after multiple doses.

En studie av ett nytt läkemedel som utförs för att jämföra effekt och säkerhet med Xenical efter flera doseringar.

A.4.1

Sponsor's protocol code number

EP-001

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Empros Pharma AB
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Empros Pharma AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CTC, Clinical Trial Consultants AB
B.5.2	Functional name of contact point	Jerker Linné
B.5.3	Address:
B.5.3.1	Street Address	Dag Hammarskjölds väg 13
B.5.3.2	Town/ city	UPPSALA
B.5.3.3	Post code	752 37
B.5.3.4	Country	Sweden
B.5.4	Telephone number	+460705292711
B.5.6	E-mail	jerker.linne@ctc-ab.se

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	EMP16-01 60/20
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ACARBOSE
D.3.9.1	CAS number	56180-94-0
D.3.9.4	EV Substance Code	SUB07368MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ORLISTAT
D.3.9.1	CAS number	96829-58-2
D.3.9.4	EV Substance Code	SUB09460MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Xenical
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ORLISTAT
D.3.9.1	CAS number	96829-58-2
D.3.9.4	EV Substance Code	SUB09460MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	120
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	EMP16-01 90/30
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ACARBOSE
D.3.9.1	CAS number	56180-94-0
D.3.9.4	EV Substance Code	SUB07368MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ORLISTAT
D.3.9.1	CAS number	96829-58-2
D.3.9.4	EV Substance Code	SUB09460MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	90
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Obesity and diabetes, type 2.

Fetma och diabetes, typ 2.

E.1.1.1

Medical condition in easily understood language

Obesity and Diabetes, type 2.

Fetma och diabetes, typ 2.

E.1.1.2

Therapeutic area

Body processes [G] - Metabolic Phenomena [G03]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the appetite/tolerability score of the test formulation (EMP16-01 90/30) with the reference formulation (Xenical®).

E.2.2

Secondary objectives of the trial

To compare the appetite/tolerability score between three different test formulations of EMP16-01 (60/20; 90/30; 120/40). To investigate safety as well as biomarkers for appetite regulation, glucose and lipid absorption and metabolism of three different doses of the test formulation (EMP16-01) and compare with the reference formulation (Xenical®).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male subjects age ≥ 24years, ≤ 60 years inclusive.
2. BMI 33 – 40 kg/m2 or BMI 30-32 kg/m2 together with waist circumference above 102 cm
3. Acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.  
4. Adequate renal function: Creatinine < 1.5 times upper limit of normal.
5. Adequate hepatic function: ASAT, ALAT, ALP and GGT < 2.5 times upper limit of normal and bilirubin <1.5 times upper limit of normal.
6. Adequate glucose control (previous not been diagnosed with diabetes Type II)
7. Willing and able to give written informed consent for participation in the study

E.4

Principal exclusion criteria

1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.
2. Any significant medical/surgical procedure or trauma within four weeks of the first administration of IMP, at the discretion of the Investigator.
3. Any planned major surgery within the duration of the study.
4. High blood pressure (Above 155/95 mmHg)
5. No medication with drugs affected by or that affect orlistat and acarbose are allowed 2 weeks before the administration of the IMP
6. Known hypersensitivity to any of the test substances.
7. Gastrointestinal problems / diseases, e.g. inflammatory bowel diseases and Irritable bowel syndrome
8. Cholestasis
9. Previous bariatic surgery
10. Previous gallbladder surgery
11. Previous gastrointestinal surgey that might influence gastrointestinal function significantly..
12. Chronical malabsorptionsyndrom
13. Vitamin B12 deficiecy or other signs of achlorhydria
14. Clinically significant abnormal laboratory values
15. History of severe allergic, cardiac, or hepatic disease
16. A personal or family history of Medullary Thyroid Carcinoma (MTC)
17. A personal or family history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
18. Shift work within 3 weeks before visit 2.
19. Excessive intake of alcohol, as judged by the Investigator
20. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse.
21. Positive screen for drugs of abuse at screening or on admission to the unit or.  
22. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
23. Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.  
24. 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 three months of the first administration of IMP in this study. Subjects consented and screened but not dosed in previous studies are not excluded.  
25. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
26. Engaged in high volume physical exercise, as defined as regular high intensity physical activity (defined as greater than 70% of the maximal pulse rate for 30 min or more) with a total weekly duration of more than 120 min/week.
27. Bile acid malabsorption

E.5 End points

E.5.1

Primary end point(s)

Appetite/Tolerability score, i.e. ratio between subjective appetite score (sum of appetite questions, measured with questionnaire) and gastrointestinal symptoms score (questionnaire assessing eg. diarrhea, flatulence, oily spotting, gastric distention and estimated frequency and intensity of nausea and pain). Daily scores will be tabulated to form a 14 day composite appetite/tolerability score.

E.5.1.1

Timepoint(s) of evaluation of this end point

The assessment will be made prior to study start and three times per day, 2h 30 min after dose, during the 14 day study period.

E.5.2

Secondary end point(s)

Appetite/tolerability score. Plasma concentration-time profiles and kinetic assessment of the following biomarkers for appetite regulation, glucose and lipid absorption and metabolism and cardiovascular health:
• Appetite/tolerability score (see above) as well as individual appetite questions
• Efficacy markers: insulin, c-peptide, glucose, TG, glucagon, GLP-1, GIP and CCK
• Safety markers: ALAT, ASAT, ALP, Lactate Dehydrogenase (LD), Creatinine, Thyroid-Stimulating Hormone (TSH), Calcitonin, albumin and CRP
• Body weight and body composition
• Meal pattern
• Plasma pharmacokinetics of orlistat

E.5.2.1

Timepoint(s) of evaluation of this end point

The assessment of Appetite/Tolerability score will be made prior to study start and three times per day, 2h 30 min after dose, during the 14 day study period.
The remaining assessments will be made on day 1 (visit 2) and day 14 (visit 4). Time points for the assessment will be; Pre-dose, 30 min, 1h, 1h 30 min, 2h, 3h 45 min, 4h 15 min, 4h 30 min, 5h, 5h 30min, 6h.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Inga

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-07-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-08-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-12-19

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