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

NCT02860923 | Completed Phase 3

• 1 other identifier: CHUBX 2012/17
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 11

Brief 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 suffering from a hypothalamic obesity due to treatment of craniopharyngioma.

Conditions

Craniopharyngiomas; Hypothalamic Obesity

Keywords

glucagon-like peptide-1; exenatide; placebo; multicenter trial

Outcome Measures

Primary Outcomes (1)

• Compare body weight change thanks to weighing machine

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

  baseline and 6 months

Secondary Outcomes (18)

• Treatment tolerance thanks to digestive parameters

  6 months

• Treatment tolerance thanks to dermatologic parameter

  6 months

• Treatment tolerance thanks to pulse rate

  6 months

• Treatment tolerance thanks to Beck scale

  6 months

• Treatment tolerance thanks to HAD scale

  6 months

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Exenatide DRUG

Exenatide

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (11)

CHU d'Angers

Angers, France

Location

CHU de Brest

Brest, France

Location

CHU de Grenoble

Grenoble, France

Location

CHU de Lyon

Lyon, France

Location

APHM

Marseille, France

Location

Hôpital Bicêtre

Paris, France

Location

Hôpital Cochin

Paris, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Hôpital Pitié Salpétrière (APHP)

Paris, France

Location

Hôpital Haut-Lévêque

Pessac, France

Location

CHU de Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Craniopharyngioma; Sexual Infantilism

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases; Hypogonadism

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Paul Perez, Dr

  University Hospital, Bordeaux

  STUDY CHAIR

• Blandine Gatta-Cherifi, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: August 9, 2016
• Study Start: January 11, 2017
• Primary Completion: June 30, 2018
• Study Completion: September 30, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)