Double-blinded, 6 Months Study With Bydureon® or Placebo in Adolescents With Obesity to Explore Changes in BMI

Combat-JUDO (Combating Juvenile Diabetes and Obesity through normalization of beta-cell function) is part of a collaborative project funded by the Seventh Framework Programme of the European Commission aiming to develop innovative therapeutic strategies by increasing pharmacology-based alternatives targeting insulin hypersecretion for the treatment of young obese individuals.

The prevalence of childhood obesity is ranging between 5-25% in Europe. The reason behind these alarming figures is mostly a changing environment with a more sedative lifestyle and supply of excess food. However, specific gene mutations have also been linked to obesity and new genes are continuously being discovered. There are very few effective means of intervention in children with obesity available today. Obesity is closely associated with a number of related metabolic diseases and some children with obesity develop the metabolic syndrome at an early stage in life. Individuals with obesity have an increased risk of developing type 2 diabetes mellitus (T2DM) and with the current increase in childhood obesity, some children will develop T2DM already in their adolescent years with huge impact on their long-term health and life expectancy.

Lifestyle modification interventions, including behavioural treatment, diet modification and physical activity, are cornerstones of primary and secondary prevention/treatment of pediatric obesity today. Exenatide is a GLP-1 (glucagon-like peptide-1) receptor agonist approved for use in adults with T2DM to improve glycemic control. A pilot study with exenatide treatment in non-diabetic children and adolescents with severe obesity showed a reduced BMI of approximately 5% and improved markers of insulin resistance and β-cell function were observed.

The Combat-JUDO study is a parallel, double-blind, randomized study comparing lifestyle intervention + exenatide 2 mg vs lifestyle and intervention + placebo in adolescents with obesity. The lifestyle intervention includes regular nutritional and psychological support at 4 occasions during the study as well as physical activity on a weekly basis. Exenatide/placebo is given as a subcutaneous injection once weekly for 24 weeks. The primary objective of the study is to compare the change in BMI-SDS (according to WHO) from baseline to the 6 months visit between the two treatment arms.

The study includes males and females of age 10-18 years and 5 months with BMI SDS >2.0 or age-adapted BMI >30 kg/m2.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Pediatrics, Salzburg State Hospital, Paracelsus Medical University, Salzburg, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed informed consent prior to any study-specific procedures.
Males or females of age 10-18 years and 5 months.
Obesity (BMI SDS > 2.0 or age-adapted BMI > 30 kg/m2), according to WHO.
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:

oral
intravaginal
transdermal
Progestogen-only hormonal contraception associated with inhibition of ovulation:

oral
injectable
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.

Exclusion criteria

Known syndromal obesity, such as Prader-Willi syndrome, Laurence-Moon syndrome or Bardet-Biedl syndrome.
Pregnancy or lactation.
Indigestion-causing diseases.
Severe gastrointestinal disease.
Total or partial gastric or small intestine resection.
Type 1 or Type 2 diabetes mellitus.
Kidney disease (acute or chronic, according to physician (Creatinin/Urea/Cystatin-C for Schwartz Calculation)).
Hypo-/Hyperthyroidism, unless under stable treatment.
Severe Vitamin D insufficiency, unless under stable treatment.
Abnormal QT interval.
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.
Severe depression, severe anxiety or other psychiatric disorder referred to or undergoing special treatment, as judged by the investigator.
Severe sleep apnea (defined clinically).
Chronic diseases, as judged by the investigator.
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.
Steroid treatment (oral or injected).
Concomitant medication addressing attention disorders.
Antidepressants that can lead to weight gain, as judged by the investigator.
Hypersensitivity to exenatide or to any of the excipients.
Pacemaker or metal implant that may interfere with Magnetic Resonance Imaging (MRI).
Claustrophobia (Uppsala and Salzburg) or abdominal diameter exceeding an MR gantry diameter of 70 cm (Salzburg).
Current or prior (within 3 months) participation in another clinical study involving an Investigational Medicinal Product (IMP).
A personal or family history of Medullary Thyroid Carcinoma (MTC)
A personal or family history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Treatment and study plan

exenatide

Drug

Bydureon (Exenatide once weekly) injections s.c.

Placebo

Behavioral

Placebo once weekly injections sc

Primary outcomes

BMI SDS (Body Mass Index Standard Deviation Score)

Time frame: 6 months

The primary objective is to compare the change from baseline to the 6 months visit, between lifestyle intervention + exenatide 2 mg once weekly and lifestyle intervention + placebo, in BMI SDS (according to WHO) for adolescents with obesity.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

A Parallel, Double-blinded, Randomized, 6 Months, Two Arms Study With Lifestyle Intervention and Bydureon® or Lifestyle Intervention and Placebo in Adolescents With Obesity to Explore Differences With Regard to Change in BMI SDS

Acronym: Combat-JUDO

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jun 9, 2016
Registry last updated: May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed