DelfaGLP-1 Atlas

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CompletedPhase 4

PDE-4 Inhibitor Roflumilast and GLP-1 Agonist Liraglutide in Polycystic Ovary Syndrome

Short-term Treatment With PDE-4 Inhibitor Roflumilast or GLP-1 Agonist Liraglutide or Metformin in Treatment Naive Obese Women With Polycystic Ovary Syndrome

Assets

GLP-1 / incretin class catch-all / Liraglutide

Listed sites

1

Recruiting sites

—

Enrollment

45

actual

Study population

Obesity / overweight, PCOS

Key I/E criterion

•Female

Primary endpoint

•Body weight, absolute change (kg)

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 IDNCT02187250
Org study IDDAXAS 2

Timeline

Milestones

Study first posted2014-07-10estimated
Last update posted2014-07-10estimated
Study start2014-03 (month precision)
Primary completion2014-06actual (month precision)
Study completion2014-06actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-allLiraglutide

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

•18 years old to menopause
•polycystic ovary syndrome (NICHD criteria)
•BMI of 30 kg/m² or higher

Exclusion criteria

•depression
•type 1 or type 2 diabetes mellitus
•history of carcinoma
•history of pancreatitis
•Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
•significant cardiovascular, kidney or hepatic disease
•the use of medications other than metformin known or suspected to affect reproductive or metabolic functions
•the use of statins, within 90 days prior to study entry

Endpoints (11)

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 clinical outcomes
5
Weight & body composition
3
Glycemic / diabetes
2
Other (unclassified)
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

The main outcome was change in body weight.

Time frame:Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial.

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

The secondary outcome was change in body mass index (BMI).

Time frame:Patient's body weight were measured at the basepoint and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint.

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

The secondary outcome was change in waist circumference.

Time frame:Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial.

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Other/protocol endpoint

The other outcomes was changes in fasting concentrations of glucose.

Time frame:Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Other/protocol endpoint

Other outcome was change in fasting concentration of insulin.

Time frame:Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.

change from baseline, improvement

Other clinical outcomes

5 endpoints
Other/protocol endpoint/low confidence

Other outcome was change in blood concentrations of LH (luteinizing hormone).

Time frame:Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.

change from baseline, improvement

Other/protocol endpoint

Other outcome was change in blood concentrations of FSH (follicle-stimulating hormone).

Time frame:Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.

change from baseline, improvement

Other/protocol endpoint

Other outcome was change in blood concentration of testosterone.

Time frame:Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.

Androgen, change

change from baseline, improvement

Other/protocol endpoint

Other outcome was change in blood concentration in androstenedione.

Time frame:Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.

Androgen, change

change from baseline, improvement

Other/protocol endpoint

Other outcome was change in blood concentration of DHEAS (dehydroepiandrosterone sulfate).

Time frame:Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.

Androgen, change

change from baseline, improvement

Other (unclassified)

1 endpoint
Other/protocol endpoint/low confidence

Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin).

Time frame:Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.

change from baseline, improvement

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.