Identification and clinical relevance of an oxytocin-deficient state: randomized, crossover, placebo-controlled pilot physiopathological study: GLP1 Study.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Participant type

Patients, Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Metabolism [G03]

Trial duration

10 Jun 2021 → 2 Aug 2024

Decision date (initial)

2024-06-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515588-67-00

EudraCT number

2020-004115-27

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

Improve knowledge of endogenous OT secretion in patients with hypopituitarism and CS.

Secondary objectives 1

1. Assessment of mood, alexithymia, impulsivity, quality of life, eating behavior and sexual function and their associations with OT secretion parameters.

Conditions and MedDRA coding

Hypopituarism

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age between 18 and 65 years.
2. Patients with hypopituitarism (HIPO), defined as more than one pituitary hormone deficit, with at least one clinical sign of hypothalamic damage.
3. Clinical signs of potential hypothalamic damage are considered to be the presence of at least one of the following: .central diabetes insipidus and/or severe obesity and/or hyperphagia and/or MRI suggestive of hypothalamic damage history of traumatic brain injury .history of irradiation of tumors affecting the hypothalamic region (e.g., craniopharyngioma, germinoma, etc.).
4. HIPO patients must be on stable hormone replacement therapy for three months prior to the prior to the study.
5. Participating women will make visits in follicular phase (between day 1 and 10 of the menstrual cycle) to minimize the effects of increased estradiol in other phases of the menstrual cycle on OT levels (23), and postmenopausal HIPO women will be compared with age-matched controls.
6. Healthy controls (HC) balanced by body mass index (BMI, if possible), age and sex with HIPO patients sex with HIPO patients.

Exclusion criteria 17

1. Uncorrected hormone deficiency.
2. Creatinine >1.5mg/dL.
3. ALT or AST >2.5x above the limit of normality.
4. Hematocrit <30%.
5. Active psychosis.
6. Participation in clinical trials with experimental drugs in the last 30 days.
7. Excessive physical activity.
8. Alcohol intake in the 24 hours prior to study participation.
9. Evidence of any acute illness or disease that the investigator determines may interfere with study participation and safety. interfere with study participation and safety.
10. Pregnancy or breastfeeding the 8 weeks before.
11. Known allergies or hypersensitivity to GLP1 receptor analogues or to some of the excipients (methacresol mannitol, glacial acetic acid, sodium acetate trihydrate). excipients (methacresol mannitol, glacial acetic acid, sodium acetate trihydrate).
12. Diabetes mellitus or under treatment with any diabetes drug.
13. Pancreatitis.
14. Patients under treatment with high doses of glucocorticoids (higher than substitute doses).
15. Potentially fertile women (after menarche and before postmenopause unless permanently sterilized by hysterectomy, salpinguectomy, or salpinguectomy. unless they have been permanently sterilized by hysterectomy, bilateral salpinguectomy and bilateral and bilateral oophorectomy) and are unwilling to take highly effective contraceptive measures during the study period highly effective contraceptive measures during the study period: combined contraceptive treatment with estrogens and progestogens associated with ovulation inhibition (oral, intravaginal, or (oral, intravaginal or transdermal), intrauterine device, sexual abstinence (abstinence from heterosexual intercourse) during the (abstinence from heterosexual intercourse) during the entire risk period associated with the study, taking into account the patient's or vascular the situation of the vasectomized patient or partner.
16. Patients who refuse or are unable to give written informed consent.
17. In addition, for CS: Presence of brain or pituitary tumor. Irradiation involving the hypothalamus or pituitary gland History of hypopituitarism History of hypopituitarism -History of testosterone, glucocorticoids or GLP1 receptor analogues. GLP1 RECEPTOR ANALOGUES.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Pattern of OT hormone secretion after administration of the study agent (GLP1 vs. placebo).

Secondary endpoints 1

1. Secondary variables will be those related to the results of validated questionnaires for the assessment of mood, alexithymia, impulsivity, quality of life, eating behavior and sexual function and their associations with OT secretion parameters.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Sponsor organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Address

Calle Sant Quinti 77-79

City

Barcelona

Postcode

08041

Country

Spain

Scientific contact point

Organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Contact name

Alejandra Espinosa Guerrero

Public contact point

Organisation

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Contact name

Alejandra Espinosa Guerrero

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications