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GATE

CompletedPhase 2

Effects of Glucagon Like Peptide 1 (GLP-1) Analogues on Fluid Intake

Effects of GLP-1 Analogues on Fluid Intake in Healthy Volunteers - "The GATE-Study"

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

17

actual

Study population

Healthy volunteers

Key I/E criterion

Primary endpoint

Fluid intake

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03141632
Org study IDGATE

Timeline

Milestones

Study start2016-10-17actual
Study first posted2017-05-05actual
Study completion2017-05-12actual
Last update posted2017-10-25actual
Primary completion2017-05actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

- Age 18 to 65 years

Exclusion criteria

Known or probable central or nephrogenic Diabetes insipidus, based on patient's history
Polyuria secondary to diabetes mellitus, hypokalemia, hypercalcemia
Primary Polydipsia, defined as more than 4 liters fluid intake per day
BMI <18 or >30kg/m2
Pregnancy
Previous treatment with GLP-1 agonists within the last 3 month
History of pancreatitis
Severe renal insufficiency (eGFR (CKD EPI) <30 ml/min/1,73 m2)
Cancer

Endpoints (17)

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)
14
Heart failure
1
Safety / tolerability / PK
1
Other clinical outcomes
1

Heart failure

1 endpoint
Secondary/protocol endpoint

Water and Salt

Time frame:3 timpoints during 8 hours

NT-proBNP, change

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Electrolytes

Time frame:3 timpoints during 8 hours

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint/low confidence

Thirst

Time frame:8 hours

descriptive

Other (unclassified)

14 endpoints
Primary/protocol endpoint/low confidence

Fluid intake

Time frame:8 hours

descriptive

Secondary/protocol endpoint/low confidence

Urine volume

Time frame:24 hours

descriptive

Secondary/protocol endpoint/low confidence

Urinary sodium

Time frame:24 hours

descriptive

Secondary/protocol endpoint/low confidence

Urine electrolytes

Time frame:3 timpoints during 8 hours

descriptive

Secondary/protocol endpoint/low confidence

copeptin

Time frame:3 timpoints during 8 hours

descriptive

Secondary/protocol endpoint/low confidence

renin

Time frame:3 timpoints during 8 hours

descriptive

Secondary/protocol endpoint/low confidence

aldosterone

Time frame:3 timpoints during 8 hours

descriptive

Secondary/protocol endpoint/low confidence

GLP-1

Time frame:3 timpoints during 8 hours

descriptive

Secondary/protocol endpoint/low confidence

Hypothalamus Pituitary Adrenal Axis (HPA)

Time frame:8 hours after Dexamethasone intake

concentration, descriptive

Secondary/protocol endpoint/low confidence

circadian rhythm

Time frame:16 hours

descriptive

Secondary/protocol endpoint/low confidence

salivary cortisol

Time frame:16 hours

descriptive

Secondary/protocol endpoint/low confidence

ACTH

Time frame:16 hours

descriptive

Secondary/protocol endpoint/low confidence

Hypothalamus Pituitary Adrenal Axis (HPA)

Time frame:0.5 hours

concentration, descriptive

Secondary/protocol endpoint/low confidence

Hypothalamus Pituitary Adrenal Axis (HPA)

Time frame:24 hours

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.