DelfaGLP-1 Atlas

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Combat-JUDO

CompletedPhase 2

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

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

Lead sponsor

Uppsala University

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

—

Enrollment

44

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥2

Primary endpoint

•BMI SDS, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02794402
Org study ID2015-001628-45

Timeline

Milestones

Study first posted2016-06-09estimated
Last update posted2022-05-18actual
Study start2015-09actual (month precision)
Primary completion2016-09actual (month precision)
Study completion2016-11actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age10 Years
Maximum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Signed informed consent prior to any study-specific procedures.

2. Males or females of age 10-18 years and 5 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:
–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

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 (Uppsala and Salzburg) or abdominal diameter exceeding an MR gantry diameter of 70 cm (Salzburg).

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).

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

1 endpoint
Primary/protocol endpoint

BMI SDS (Body Mass Index Standard Deviation Score)

Time frame:6 months

BMI SDS, change

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.