Clinical Trials Register

Summary
EudraCT Number:	2015-001628-45
Sponsor's Protocol Code Number:	2.0
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:	2015-07-27
Trial 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

2015-001628-45

A.3

Full title of the trial

A parallel, double-blinded, randomized, 6 months, two arms study with lifestyle intervention and exenatide 2 mg once weekly or lifestyle intervention and placebo in adolescents with obesity to explore differences between groups with regard to change in BMI SDS (according to WHO).

A.3.1

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

A study with lifestyle intervention and study medication once weekly or lifestyle intervention and placebo in adolescents with obesity to explore differences between groups with regard to change in BMI.

A.3.2

Name or abbreviated title of the trial where available

Combat-JUDO

A.4.1

Sponsor's protocol code number

2.0

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	Dep. of Medical Cell Biology Uppsala University
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	European Commission's Seventh Framework Programm (FP7) project Beta_JUDO (grant 279153)
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	Dep of Medical Cell Biology Uppsla University
B.5.2	Functional name of contact point	Peter Bergsten
B.5.3	Address:
B.5.3.1	Street Address	Box 571
B.5.3.2	Town/ city	Uppsala
B.5.3.3	Post code	75123
B.5.3.4	Country	Sweden
B.5.4	Telephone number	+46184714923
B.5.6	E-mail	peter.bergsten@mcb.uu.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	Yes
D.2.1.1.1	Trade name	Bydureon®
D.2.1.1.2	Name of the Marketing Authorisation holder	Astra Zeneca AB
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.3.1	Product name	Bydureon®
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Obesity in adolescents

E.1.1.1

Medical condition in easily understood language

Obesity

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 change from baseline to the 6 months visit at the end of treatment, between
lifestyle intervention + exenatide 2 mg once weekly and lifestyle intervention + placebo,
in BMI SDS (according to WHO) for adolescents with obesity.

E.2.2

Secondary objectives of the trial

1. To evaluate safety and tolerability.
2. To compare changes in beta-cell function within the groups and between the groups from baseline to the 6 months visit.
3. To compare changes in glucagon levels within the groups and between the groups from baseline to the 6 months visit.
4. To compare changes in cardiovascular risk factors and pattern changes in Free Fatty Acids (FFAs) within the groups and between the groups from baseline to the 6 months visit.
5. To compare changes in high sensitivity C-Reactive Protein (hs-CRP) within the groups and between the groups from baseline to the 6 months visit.
6. To compare changes in body composition characteristics within the groups and between the groups from baseline to the 6 months visit.
7. To compare changes in anthropometrics within the groups and between the groups from baseline to the 6 months visit.
8. To compare the change in s-BMI within the groups and between the groups from baseline to the 6 months visit. 9-11 in csp.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed informed consent prior to any study-specific procedures.
2. Males or females of age 10-18 years and 7 months.
3. Obesity (BMI SDS > 2.0 or age-adapted BMI > 30 kg/m2), according to WHO.
4. Not sexually active or usage of adequate anticonception. Female subjects must also have negative pregnancy tests.
Methods that can achieve a failure rate of less than 1% per year (Pearl index <1), when used consistently and correctly, are considered as highly effective birth control methods. Such methods include:
• Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
o oral
o intravaginal
o transdermal
• Progestogen-only hormonal contraception associated with inhibition of ovulation:
o oral
o injectable
o implantable
• Intrauterine device (IUD)
• Intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion
• Vasectomised partner
• Sexual abstinence (if refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the preferred and usual lifestyle of the subject).
5. Ability to understand and comply with the requirements of the study

E.4

Principal exclusion criteria

1. Known syndromal obesity, such as Prader-Willi syndrome, Laurence-Moon syndrome or Bardet-Biedl syndrome.
2. Pregnancy or lactation.
3. Indigestion-causing diseases.
4. Severe gastrointestinal disease.
5. Total or partial gastric or small intestine resection.
6. Type 1 or Type 2 diabetes mellitus.
7. Kidney disease (acute or chronic, according to physician (Creatinin/Urea/Cystatin-C for Schwartz Calculation)).
8. Hypo-/Hyperthyroidism, unless under stable treatment.
9. Severe Vitamin D insufficiency, unless under stable treatment.
10. Abnormal QT interval.
11. Clinically significant abnormal laboratory values, e.g.
Triglycerides > 400 mg/dl (Salzburg) or > 4,5 mmol/L (Uppsala),
Amylase > 300 U/L (Salzburg) or > 5,1 µkat/L (Uppsala),
Lipase > 180 U/L (Salzburg) or > 15 µkat/L (Uppsala) or
Calcitonin > 11.7 pg/ml (Salzburg) or > 3,4 pmol/L (Uppsala) for females and > 17 pg/ml (Salzburg) or > 5,0 pmol/L (Uppsala) for males.
12. Severe depression, severe anxiety or other psychiatric disorder referred to or undergoing special treatment, as judged by the investigator.
13. Severe sleep apnea (defined clinically).
14. Chronic diseases, as judged by the investigator.
15. Metformin treatment within 3 months prior to screening or concomitant medication influencing blood glucose (e.g. metformin and acarbose), influencing other parameters of metabolic syndrome (e.g. orlistat) or interfering with the investigational medicinal product.
16. Steroid treatment (oral or injected).
17. Concomitant medication addressing attention disorders.
18. Antidepressants that can lead to weight gain, as judged by the investigator.
19. Hypersensitivity to exenatide or to any of the excipients.
20. Pacemaker or metal implant that may interfere with Magnetic Resonance Imaging (MRI).
21. Claustrophobia.
22. Current or prior (within 3 months) participation in another clinical study involving an Investigational Medicinal Product (IMP).
23. A personal or family history of Medullary Thyroid Carcinoma (MTC)
24. A personal or family history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

E.5 End points

E.5.1

Primary end point(s)

BMI SDS (according to WHO).

E.5.1.1

Timepoint(s) of evaluation of this end point

At end of study

E.5.2

Secondary end point(s)

Adverse events, vital signs (blood pressure and pulse), electrocardiogram (ECG), tympanic body temperature, glucose, clinical chemistry, hematology and urinalysis.

2. Endpoints of insulin secretion and sensitivity derived from Oral Glucose Tolerance Test (OGTT).

3. Glucagon levels at specified time points.

4. Triglycerides, High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), total cholesterol, FFAs, apolipoproteins, uric acid and blood pressure.

5. hs-CRP
6. Bioimpedance assessments to calculate total and regional body composition and Magnetic Resonance Imaging (MRI) assessments of abdominal adipose tissue, organ fat characteristics and morphology (volume of Visceral and abdominal Subcutaneous Adipose Tissue (VAT/SAT) and Liver Fat (LF) content)
7. Waist, hip, upper thigh and neck circumference, waist-to-hip-ratio, sagittal abdominal diameter and skinfold caliper assessments of body fat.
8. s-BMI.
9. Interdisciplinary Adiposity Evaluation kit (AD-EVA), Sleeping habits questionnaire, Self-efficacy and outcome expectations questionnaire (SWE & HEE), Food Frequency Questionnaire (FFQ), Regular meals questionnaire, Portion size questionnaire, Walking test (6 min.), Physical activity questionnaire and Physical activity assessed by accelerometry.
10. U-alpha1-microglobulin (protein HC)/Creatinine and estimated Glomerular Filtration Rate (GFR) according to Schwartz formula.
11. Aspartate Aminotransferase (ASAT), Alanine Aminotransferase (ALAT), Gamma-Glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LD) and Bilirubin.

E.5.2.1

Timepoint(s) of evaluation of this end point

At end of study

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

Yes

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

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

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

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-07-27.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Minors 10-17 years old

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Will not be different from expected normal treatment.

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

2015-08-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-09-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-09-13

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