ObesityPhase 2Combat-JUDONCT02794402
Double-blinded, 6 Months Study With Bydureon® or Placebo in Adolescents With Obesity to Explore Changes in BMI
A Phase 2 study testing Exenatide in people with Obesity, run by Uppsala University at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Obesity
- What is being tested?
- Exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2015to Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site
Department of Pediatrics, Salzburg State Hospital, Paracelsus Medical University
Salzburg, 5020
About this study
Official 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
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.
Read more
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.
- Conditions
- Obesity
- Being tested
- Exenatide, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Bydureon (Exenatide once weekly) injections s.c.
PlaceboBehavioural
Placebo once weekly injections sc
| Study group | Role | What they receive |
|---|---|---|
| Bydureon | Active comparator | s.c. once Weekly Receives: Drug: Exenatide |
| Placebo | Placebo comparator | s.c. once Weekly Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI SDS (Body Mass Index Standard Deviation Score)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Bergsten, Uppsala University
- Investigators
- Anders Forslund, Assoc Prof, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794402
- Sponsor's protocol ID
- 2015-001628-45
- Other IDs
- 2015
- Acronym
- Combat-JUDO
- Status last verified
- May 2022
- First submitted
- 17 May 2016
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stenlid R, Cerenius SY, Wen Q, Aydin BK, Manell H, Chowdhury A, Kristinsson H, Ciba I, Gjessing ES, Morwald K, Gomahr J, Heu V, Weghuber D, Forslund A, Bergsten P. Adolescents with obesity treated with exenatide maintain endogenous GLP-1, reduce DPP-4, and improve glycemic control. Front Endocrinol (Lausanne). 2023 Nov 1;14:1293093. doi: 10.3389/fendo.2023.1293093. eCollection 2023.
PubMed 38027106
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02794402
- Acronym / sponsor ID
- Combat-JUDO / 2015-001628-45
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bydureon | Active comparator | Drug: Exenatides.c. once Weekly |
| Placebo | Placebo comparator | Behavioral: Placebos.c. once Weekly |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExenatideBydureon (Exenatide once weekly) injections s.c. | Drug | Bydureon |
| PlaceboPlacebo once weekly injections sc | Behavioural | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 38027106Stenlid R, Cerenius SY, Wen Q, Aydin BK, Manell H, Chowdhury A, Kristinsson H, Ciba I, Gjessing ES, Morwald K, Gomahr J, Heu V, Weghuber D, Forslund A, Bergsten P. Adolescents with obesity treated with exenatide maintain endogenous GLP-1, reduce DPP-4, and improve glycemic control. Front Endocrinol (Lausanne). 2023 Nov 1;14:1293093. doi: 10.3389/fendo.2023.1293093. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Forslund, Assoc Prof principal investigator
Uppsala University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exenatide in people with Obesity, run by Uppsala University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI SDS (Body Mass Index Standard Deviation Score) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.