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CraniopharyngiomasPhase 3CRANIOEXENCT02860923

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

A Phase 3 study testing Exenatide in people with Craniopharyngiomas and Hypothalamic Obesity, run by University Hospital, Bordeaux at 11 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This hypothalamic obesity is associated with serious metabolic and psychosocial consequences. The purpose of the study is to compare the change of body weight after 6 months treatment with a lifestyle intervention + exenatide compare to the one after the same lifestyle intervention+ placebo in adults patients… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Craniopharyngiomas, Hypothalamic 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
42 participants
Where
11 sitesFrance
Study dates
11 Jan 2017to 30 Sep 2018
Phase
Phase 3
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • CHU d'Angers

    Angers

  • CHU de Brest

    Brest

  • CHU de Grenoble

    Grenoble

  • CHU de Lyon

    Lyon

  • APHM

    Marseille

  • Hôpital Bicêtre

    Paris

  • Hôpital Cochin

    Paris

  • Hôpital Européen Georges Pompidou

    Paris

  • Hôpital Pitié Salpétrière (APHP)

    Paris

  • Hôpital Haut-Lévêque

    Pessac

  • CHU de Toulouse

    Toulouse

Other trials in France

About this study

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

This hypothalamic obesity is associated with serious metabolic and psychosocial consequences.

The purpose of the study is to compare the change of body weight after 6 months treatment with a lifestyle intervention + exenatide compare to the one after the same lifestyle intervention+ placebo in adults patients suffering from a hypothalamic obesity due to treatment of craniopharyngioma.

Read the detailed description

The development of glucagon-like peptide-1 (GLP-1) analogues might be a solution since native GLP-1 suppresses appetite and energy intake in both normal weight and obese individuals as well as in people with type 2 diabetes and delays gastric emptying. The underlying mechanisms that mediate the effects of weight involve not only central regions like the hypothalamus and the solitary tractus nucleus and area postrema but also peripheral regions as the gastrointestinal tract. These extra hypothalamic effects are of particular interest in the cases of obesity due to hypothalamic lesions.

Exenatide is a glucagon-like peptide-1 (GLP-1) analogue with a high structural homology to human GLP-1, a gut derived incretin hormone. Since exenatide causes a dose-dependent weight loss, decreasing concentration of glycosylated haemoglobin as well as improving ß-cell function and systolic blood pressure, it could be an attractive treatment for both type 2 diabetes and obesity. In a double-blind placebo-controlled 24-week trial, it has been recently shown that non diabetic obese patients maintained on exenatide 10µg x 2/j lost significantly more weight than did those on placebo (5.1 kg versus 1.6).

Being tested
Exenatide, Placebo
Keywords
glucagon-like peptide-1, exenatide, placebo, multicenter trial
Medical subject headings
Craniopharyngioma, Sexual Infantilism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExenatideDrug

  • PlaceboDrug

Study groups in NCT02860923
Study groupRoleWhat they receive
ExenatideExperimentalTreatment with exenatide at the initial dose of 5 µg x 2/day (subcutaneously administered) during 4 weeks, and treatment with 10 µg x 2/day during 5 months.
Receives: Drug: Exenatide
PlaceboPlacebo comparatorPatients will be maintained on placebo (injected subcutaneously, twice a day) with the same dose and frequency than exenatide arm.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare body weight change thanks to weighing machine

    The primary outcome will be assessed by a weighing machine that measure until 200 kg.

    Measured: baseline and 6 months

Secondary outcomes (18)

  1. Treatment tolerance thanks to digestive parameters

    Tolerance will be assessed by the presence of:

    • Nauseas, vomiting.

    Measured: 6 months

  2. Treatment tolerance thanks to dermatologic parameter

    Tolerance will be assessed by the presence of:

    • Injection-site symptoms.

    Measured: 6 months

  3. Treatment tolerance thanks to pulse rate

    Tolerance will be assessed by the presence of :

    • Increasing of pulse rate.

    Measured: 6 months

  4. Treatment tolerance thanks to Beck scale

    Tolerance will be assessed by the presence of :

    • Anxiety by Beck scale.

    Measured: 6 months

  5. Treatment tolerance thanks to HAD scale

    Tolerance will be assessed by the presence of :

    • depression evaluated by HAD scale.

    Measured: 6 months

  6. Treatment tolerance thanks to enzymatic parameters

    Tolerance will be assessed by the presence of :

    • Increasing of pancreatic enzymes.

    Measured: 6 months

  7. Treatment tolerance thanks to glycemia parameter

    Tolerance will be assessed by the presence of :

    • Hypoglycaemia

    Measured: 6 months

  8. Assess cardiovascular risks thanks to glucose profil

    Levels of blood glucose and insulin, oral glucose tolerance testing, haemoglobin A1C

    Measured: 6 months

  9. Assess cardiovascular risks thanks to lipid profil

    Levels of HDL cholesterol, triglycerides, LDL cholesterol.

    Measured: 6 months

  10. Assess cardiovascular risks thanks to metabolic parameters

    The metabolic parameters considered:

    • Body composition (Dual energy-ray absorptiometry) and abdominal obesity (waist circumference).

    Measured: 6 months

  11. Assess eating behaviour thanks to physiological parameters

    The eating behaviour will be evaluated by:

    • Plasma level of ghrelin measured after an overnight fast.

    Measured: 6 months

  12. Assess eating behaviour thanks to energy intake

    Measured: 6 months

  13. Assess eating behaviour thanks to Three factor eating

    The eating behaviour will be evaluated by:

    • Scores of restriction, hunger and disinhibition (French version of the Three factor Eating Questionnaire).

    Measured: 6 months

  14. Assess eating behaviour thanks to visual analogic scales

    The eating behaviour will be evaluated by:

    • Scores of desire to eat, hunger and fullness at visual analogic scales.

    Measured: 6 months

  15. Assess quality of life thanks to Beck questionnaire

    The quality of life will be assessed by:

    • Scores of depression (short questionnaire of Beck).

    Measured: 6 months

  16. Assess quality of life thanks to ORWELL questionnaire

    The quality of life will be assessed by:

    • Scores of quality of life (ORWELL questionnaire).

    Measured: 6 months

  17. Assess energy expenditure thanks to physical activity

    The energy expenditure will be estimated thanks to pedometer.

    • Resting metabolic rate (indirect calorimetry).

    Measured: 6 months

  18. Assess energy expenditure thanks to indirect calorimetry

    The energy expenditure will be estimated thanks to:

    • Resting metabolic rate

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2016 (estimated)
  2. Study start11 Jan 2017
  3. Primary completion30 Jun 2018
  4. Study completion30 Sep 2018

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02860923
Sponsor's protocol ID
CHUBX 2012/17
Other IDs
2013-004755-21
Acronym
CRANIOEXE
Status last verified
Oct 2018
First submitted
24 Jun 2016
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Gatta-Cherifi B, Mohammedi K, Cariou T, Poitou C, Touraine P, Raverot G, Brue T, Chanson P, Illouz F, Grunenwald S, Chabre O, Sonnet E, Cuny T, Bertherat J, Czernichow S, Frison E, Tabarin A. Impact of exenatide on weight loss and eating behavior in adults with craniopharyngioma-related obesity: the CRANIOEXE randomized placebo-controlled trial. Eur J Endocrinol. 2024 Mar 30;190(4):257-265. doi: 10.1093/ejendo/lvae024.

    PubMed 38450721

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Exenatide in people with Craniopharyngiomas and Hypothalamic Obesity, run by University Hospital, Bordeaux at 11 sites in France.

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 6 inclusion and 15 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Compare body weight change thanks to weighing machine (time frame: baseline and 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 NCT02860923, 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 22 May 2026.

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