CompletedPhase 4

Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study)

Identification and Clinical Relevance of an Oxytocin Deficient State: a Randomized, Crossover, Placebo-controlled, Proof-of-concept, Physiopathological Study (GLP1 Study)

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•Healthy volunteers

Primary endpoint

•Oxytocin concentration (pg/mL)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04897802

Org study IDIIBSP-OXI-2020-102

Timeline

Milestones

Study first posted2021-05-24actual

Study start2021-09-13actual

Primary completion2024-04-30actual

Study completion2024-12-31actual

Last update posted2026-01-20actual

Assets

Investigational agents

Exenatide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Patients with hypopituitarism (HYPO) (>1 pituitary hormone deficiency) and stable hormone replacement for the prior three months

•At least one clinical sign of hypothalamic damage

•Female participants will be done in the early to midfollicular phase

Exclusion criteria

•uncorrected hormone deficiency

•creatinine >1.5mg/dL

•alanine aminotransferase (ALT) or aspartate amino transferase (AST) >2.5x upper limit of normal

•hematocrit less than 30%

•suicidality or active psychosis

•participation in a trial with investigational drugs within 30 days

•using a high glucocorticoid dose

•Any type of diabetes mellitus

•Obese patients on GLP1-RA therapies

•vigorous physical exercise

•alcohol intake within 24 hours before the study participation

•evidence of any acute illness or any illness that the Investigator determines could interfere with study participation or safety

•pregnancy or breastfeeding for last 8 weeks

•known allergies towards GLP1-RA

•patients refusing or unable to give written informed consent

•Additionally for healthy controls: the presence of brain or pituitary tumor, radiation involving the hypothalamus or pituitary, history of hypopituitarism or receiving testosterone or glucocorticoids esters.

Endpoints (9)

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

Other (unclassified)

Glycemic / diabetes

Patient-reported / QoL

Other clinical outcomes

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in glucose concentration (mg/dL)

Time frame:Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in insulin concentration (pmol/L)

Time frame:Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Mood assessment

Time frame:Baseline

descriptive

Secondary/protocol endpoint

Quality of life assessment

Time frame:Baseline

SF-36 total

descriptive

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint/low confidence

Impulsivity assessment

Time frame:Baseline

descriptive

Secondary/protocol endpoint

Alexithymia assessment

Time frame:Baseline

descriptive

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Change in oxytocin concentration (pg/mL)

Time frame:Baseline blood exam (timepoint 0) and further blood collections after 15, 30, 45, 60, 90 and 120 minutes after baseline blood collection

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Maximal change in oxytocin concentration (pg/mL)

Time frame:Within the two hours after the injection

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Overall oxytocin secretion (pg/mL)

Time frame:Within the two hours after the injection

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.