DelfaGLP-1 Atlas

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GOLD

CompletedPhase 2

Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia (The GOLD-Study)

Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia: "The GOLD-Study"

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

50

actual

Study population

—

Key I/E criterion

—

Primary endpoint

•Fluid intake in ml

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 IDNCT02770885
Org study IDGOLD 2016

Timeline

Milestones

Study first posted2016-05-12estimated
Primary completion2019-05-17actual
Study completion2019-10-07actual
Last update posted2020-01-18actual
Study start2016-03 (month precision)

Assets

Investigational agents

Dulaglutide

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age over 18 years
•Polyuria of > 50 ml/Kg/day
•Polydipsia of > 3 liters/day

Exclusion criteria

•Known or probable central or nephrogenic Diabetes insipidus, expected from patient's history
•Polyuria secondary to diabetes mellitus, hypokalemia, hypercalcemia
•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 (10)

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)
5
Other clinical outcomes
3
Cardiometabolic biomarkers
1
Patient-reported / QoL
1

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint/low confidence

Copeptin level

Time frame:at begin of evaluation 1 day visit after an overnight fast (no drink, no food)

descriptive

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Quality of Life Assessment using the Short Form-12 (SF-12) Questionnaire

Time frame:During phase a and b, 3 weeks each

descriptive, improvement

Other clinical outcomes

3 endpoints
Secondary/protocol endpoint/low confidence

Influence of dulaglutide on neuronal changes

Time frame:during phase a and b, 3rd week each for 15 patients

descriptive

Secondary/protocol endpoint/low confidence

Neuronal changes between patients with primary polydipsia and healthy volunteers

Time frame:for patients during phase a and b, 3rd week each for 15 patients, 15 matched healthy control subjects

descriptive

Secondary/protocol endpoint/low confidence

Thirst perception

Time frame:during phase a and b, 3 weeks each and change during evaluation visit of 8 hours

descriptive

Other (unclassified)

5 endpoints
Primary/protocol endpoint/low confidence

Fluid intake in ml

Time frame:8 hours

descriptive

Secondary/protocol endpoint/low confidence

24h-urine production

Time frame:24 hours

descriptive

Secondary/protocol endpoint/low confidence

Plasma- and urine osmolality

Time frame:change during evaluation visit of 8 hours

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Circadian serum- and salivary cortisol levels

Time frame:circadian rhythm assessed at timepoints 8am, 12am, 4pm, 8pm and 12pm

descriptive

Secondary/protocol endpoint/low confidence

Cortisol levels basal and stimulated

Time frame:Cortisol at timepoint 0 and after 20-30 minutes after synacthen injection

change from baseline, descriptive

Publications (2)

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.