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 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). - Combat-JUDO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001628-45-SE

Enrollment

Registered

2015-07-27

Start date

2015-09-09

Completion date

Unknown

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity in adolescents

Interventions

Trade Name: Bydureon® Product Name: Bydureon® Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutane

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: 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. ;Primary end point(s): BMI SDS (according to WHO). ;Timepoint(s) of evaluation of this end point: At end of study	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: 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. ;Primary end point(s): BMI SDS (according to WHO). ;Timepoint(s) of evaluation of this end point: At end of study

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Secondary

Measure	Time frame
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. ;Timepoint(s) of evaluation of this end point: At end of study	—

Measure

Time frame

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. ;Timepoint(s) of evaluation of this end point: At end of study

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Countries

Sweden

Contacts

Public ContactPeter Bergsten

Dep of Medical Cell Biology Uppsla University

peter.bergsten@mcb.uu.se+46184714923

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026