DelfaGLP-1 Atlas

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CRANIOEXE

CompletedPhase 3

Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy

Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy

Asset

Exenatide

GLP-1 agonist

Listed sites

11

Recruiting sites

—

Enrollment

42

actual

Study population

Hypothalamic / syndromic obesity, Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Body weight, absolute change (kg)

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 IDNCT02860923
Org study IDCHUBX 2012/17
Secondary ID2013-004755-21

Timeline

Milestones

Study first posted2016-08-09estimated
Study start2017-01-11actual
Primary completion2018-06-30actual
Study completion2018-09-30actual
Last update posted2026-05-22actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Hypothalamic / syndromic obesityObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•They are between 18 and 75 yrs.
•They had been diagnosed with a craniopharyngioma treated by surgery and/or irradiation without sign of recurrence.
•They have a BMI upper than 30kg/m² with intractable weight gain following therapy for craniopharyngioma.
•They demonstrate at least one other endocrinopathy, as a marker of hypothalamic damage.
•All pituitary deficiencies are correctly treated.
•They gave their written, informed consent before the beginning of the study.

Exclusion criteria

•They have type 1 diabetes.
•They have type 2 diabetes treated with insulin.
•Acidocetosis.
•Bariatric surgery
•Previous personal history of thyroid or pancreatic cancer.
•Hypercalcitoninemia.
•They have been previously treated by GLP1 analogs.
•Hypertriglyceridemia upper than 5g/l
•They had previously demonstrated voluntary weight loss during the three previous months.
•They are under the age of 18 years or over the age of 65 yrs.
•They are maintained on medical treatment against obesity.
•They are receiving supraphysiologic hydrocortisone therapy (upper than 30 mg/jour).
•Their GH status change during the course of the study.
•Exenatide is contraindicated.
•Psychological and/or medical problems that would create difficulties for the patient to comply with the study protocol are present.

Endpoints (19)

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.

Coverage by outcome category

Patient-reported / QoL
6
Safety / tolerability / PK
4
Other (unclassified)
3
Weight & body composition
2
Cardiometabolic biomarkers
2
Glycemic / diabetes
1
Other clinical outcomes
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Compare body weight change thanks to weighing machine

Time frame:baseline and 6 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Assess cardiovascular risks thanks to metabolic parameters

Time frame:6 months

descriptive, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint/low confidence

Assess cardiovascular risks thanks to glucose profil

Time frame:6 months

descriptive

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Treatment tolerance thanks to pulse rate

Time frame:6 months

Heart rate, change

change from baseline, descriptive

Secondary/protocol endpoint

Assess cardiovascular risks thanks to lipid profil

Time frame:6 months

change from baseline, improvement

Patient-reported / QoL

6 endpoints
Secondary/protocol endpoint

Treatment tolerance thanks to Beck scale

Time frame:6 months

descriptive

Secondary/protocol endpoint

Treatment tolerance thanks to HAD scale

Time frame:6 months

descriptive, improvement

Secondary/protocol endpoint

Assess eating behaviour thanks to Three factor eating

Time frame:6 months

descriptive

Secondary/protocol endpoint

Assess eating behaviour thanks to visual analogic scales

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Assess quality of life thanks to Beck questionnaire

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Assess quality of life thanks to ORWELL questionnaire

Time frame:6 months

descriptive, improvement

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Treatment tolerance thanks to digestive parameters

Time frame:6 months

Nausea

descriptive, event

componentsNausea, Vomiting

Secondary/protocol endpoint

Treatment tolerance thanks to dermatologic parameter

Time frame:6 months

categorical status, event

Secondary/protocol endpoint/low confidence

Treatment tolerance thanks to enzymatic parameters

Time frame:6 months

categorical status, event

Secondary/protocol endpoint

Treatment tolerance thanks to glycemia parameter

Time frame:6 months

categorical status, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint/low confidence

Assess eating behaviour thanks to energy intake

Time frame:6 months

descriptive

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Assess eating behaviour thanks to physiological parameters

Time frame:6 months

concentration, descriptive

Secondary/protocol endpoint/low confidence

Assess energy expenditure thanks to physical activity

Time frame:6 months

descriptive

Secondary/protocol endpoint/low confidence

Assess energy expenditure thanks to indirect calorimetry

Time frame:6 months

descriptive

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.