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.
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
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.
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- 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
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).
- Conditions
- Craniopharyngiomas, Hypothalamic Obesity
- 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 group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | Treatment 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 |
| Placebo | Placebo comparator | Patients 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.
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)
Treatment tolerance thanks to digestive parameters
Tolerance will be assessed by the presence of:
- Nauseas, vomiting.
Measured: 6 months
Treatment tolerance thanks to dermatologic parameter
Tolerance will be assessed by the presence of:
- Injection-site symptoms.
Measured: 6 months
Treatment tolerance thanks to pulse rate
Tolerance will be assessed by the presence of :
- Increasing of pulse rate.
Measured: 6 months
Treatment tolerance thanks to Beck scale
Tolerance will be assessed by the presence of :
- Anxiety by Beck scale.
Measured: 6 months
Treatment tolerance thanks to HAD scale
Tolerance will be assessed by the presence of :
- depression evaluated by HAD scale.
Measured: 6 months
Treatment tolerance thanks to enzymatic parameters
Tolerance will be assessed by the presence of :
- Increasing of pancreatic enzymes.
Measured: 6 months
Treatment tolerance thanks to glycemia parameter
Tolerance will be assessed by the presence of :
- Hypoglycaemia
Measured: 6 months
Assess cardiovascular risks thanks to glucose profil
Levels of blood glucose and insulin, oral glucose tolerance testing, haemoglobin A1C
Measured: 6 months
Assess cardiovascular risks thanks to lipid profil
Levels of HDL cholesterol, triglycerides, LDL cholesterol.
Measured: 6 months
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
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
Assess eating behaviour thanks to energy intake
Measured: 6 months
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
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
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
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
Assess energy expenditure thanks to physical activity
The energy expenditure will be estimated thanks to pedometer.
- Resting metabolic rate (indirect calorimetry).
Measured: 6 months
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.
- First posted9 Aug 2016 (estimated)
- Study start11 Jan 2017
- Primary completion30 Jun 2018
- Study completion30 Sep 2018
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 CraniopharyngiomasStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Perez, Dr, Study chair, University Hospital, BordeauxBlandine Gatta-Cherifi, Pr, Principal investigator, University Hospital, Bordeaux
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