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LIPT

CompletedPhase 4Results posted

LIPT - Liraglutide in Polycystic Ovary Syndrome

A Randomised, Double-blind, Placebo-controlled Study of the Effect of Liraglutide in Polycystic Ovary Syndrome on Risk Markers of Vascular Thrombosis.

Lead sponsor

Jens Faber

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

PCOS

Key I/E criteria

•BMI ≥25•Female

Primary endpoint

•Endogenous Thrombin Potential (ETP)

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 IDNCT02073929

Org study IDEudraCT nr 2013-003862-15

Timeline

Milestones

Study first posted2014-02-28estimated

Last update posted2019-02-28actual

Results first posted2019-02-28actual

Study start2014-03 (month precision)

Primary completion2015-12actual (month precision)

Study completion2015-12actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

PCOS

Eligibility

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•PCOS

•>18 years

•premenopausal

•BMI >25 og 25 and thereunder + insulin resistent

Exclusion criteria

(including):

•actualt or intended pregnancy

•inadeqvat contraception

•hormonal contraception within 6 weeks

•metfoomin, GLP-1-analog or DPP IV inhibitor within 3 months

•medications affectiv hemostatic mechanisme

•diabetes or other severe comorbidity

•familar MEN

•...

Endpoints (22)

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

Cardiometabolic biomarkers

Other clinical outcomes

Weight & body composition

MASH / liver

Heart failure

Safety / tolerability / PK

Weight & body composition

2 endpoints

Other/protocol endpoint

Change in Body Composition (VAT)

Time frame:at time 0 and 26 weeks

Visceral fat, change

change from baseline, improvement

Other_pre_specified/registry result

Change in Body Composition (VAT)

Time frame:at time 0 and 26 weeks

Visceral fat, change

change from baseline, improvement

Posted result

Group	Value (mean), cubic cm	95% CI
Liraglutide	-17	—
Placebo	5	—

MASH / liver

2 endpoints

Other/protocol endpoint

Change in Percent Liver Fat Content

Time frame:at time 0 and 26 weeks

Liver fat content, change

change from baseline, improvement

Other_pre_specified/registry result

Change in Percent Liver Fat Content

Time frame:at time 0 and 26 weeks

Liver fat content, change

change from baseline, improvement

Posted result

Group	Value (mean), percentage of liver fat	95% CI
Liraglutide	-1.6	—
Placebo	-0.2	—

Heart failure

2 endpoints

Other/protocol endpoint

Change in Plasma Level of Atrial Natriuretic Peptide (ANP)

Time frame:at time 0 and 26 weeks

change from baseline, improvement

Other_pre_specified/registry result/low confidence

Change in Plasma Level of Atrial Natriuretic Peptide (ANP)

Time frame:at time 0 and 26 weeks

change from baseline, descriptive

Posted result

Group	Value (median), pmol/l	95% CI
Liraglutide	-11.5	-17.0 – -6.1
Placebo	1.4	-7.5 – 10.2

Cardiometabolic biomarkers

10 endpoints

Primary/registry result

Change in Endogenous Thrombin Potential (ETP)

Time frame:at time 0 and 26 weeks

change from baseline, improvement

Posted result

Group	Value (mean), nMolar x minutes	95% CI
Liraglutide	-56.7	-132.3 – 17.2
Placebo	-8.2	-98.7 – 82.3

Primary/protocol endpoint/low confidence

Change in Endogenous Thrombin Potential (ETP)

Time frame:at time 0 and 26 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1

Time frame:at time 0 and 26 weeks

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change in plasma PAI-1	95% CI
Liraglutide	-12	-23 – 0
Placebo	4	-14 – 26

Secondary/protocol endpoint

Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1

Time frame:at time 0 and 26 weeks

percent change from baseline, improvement

Other/protocol endpoint

Change in Plasma Level of Adrenomedullin

Time frame:at time 0 and 26 weeks

change from baseline, improvement

Other/protocol endpoint

Change in Plasma Level of Copeptin

Time frame:at time 0 and 26 weeks

change from baseline, improvement

Other/protocol endpoint

Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)

Time frame:at time 0 and 26 weeks

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Other_pre_specified/registry result/low confidence

Change in Plasma Level of Adrenomedullin

Time frame:at time 0 and 26 weeks

change from baseline, improvement

Posted result

Group	Value (median), nmol/l	95% CI
Liraglutide	-0.02	-0.04 – 0.002
Placebo	0.003	-0.02 – 0.02

Other_pre_specified/registry result

Change in Plasma Level of Copeptin

Time frame:at time 0 and 26 weeks

change from baseline, improvement

Posted result

Group	Value (median), pmol/l	95% CI
Liraglutide	0.48	-0.39 – 1.34
Placebo	0.28	-0.51 – 1.08

Other_pre_specified/registry result

Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)

Time frame:at time 0 and 26 weeks

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Posted result

Group	Value (mean), percent change in CRP levels	95% CI
Liraglutide	-15	-30 – 3
Placebo	-25	-57 – 30

Safety / tolerability / PK

1 endpoint

Other_pre_specified/registry result/low confidence

Change in Bleeding Pattern (Bleeding Ratio)

Time frame:at time 0 and 26 weeks

ratio, descriptive

Posted result

Group	Value (median), n of bleedings/n of expected bleedings	95% CI
Liraglutide	0.28	0.20 – 0.36
Placebo	0.14	0.02 – 0.26

Other clinical outcomes

5 endpoints

Other/protocol endpoint/low confidence

Change in Bleeding Pattern (Bleeding Ratio)

Time frame:at time 0 and 26 weeks

ratio, descriptive

Other/protocol endpoint

Change in Ovarian Volume Between Baseline and Follow up (26 Weeks)

Time frame:at time 0 and 26 weeks

change from baseline, improvement

Other/protocol endpoint

Change in Serum Levels of Anti-Müllerian Hormone

Time frame:at time 0 and 26 weeks

change from baseline, improvement

Other_pre_specified/registry result/low confidence

Change in Ovarian Volume Between Baseline and Follow up (26 Weeks)

Time frame:at time 0 and 26 weeks

change from baseline, improvement

Posted result

Group	Value (mean), ml	95% CI
Liraglutide	-2	-3 – -1
Placebo	0	-2 – 1

Other_pre_specified/registry result

Change in Serum Levels of Anti-Müllerian Hormone

Time frame:at time 0 and 26 weeks

change from baseline, improvement

Posted result

Group	Value (mean), pmol/ml	95% CI
Liraglutide	-8.7	-17.4 – 0.6
Placebo	3.5	-13.9 – 21.0

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

Effect of liraglutide on ectopic fat in polycystic ovary syndrome: A randomized clinical trial.
Diabetes, obesity & metabolism2018 Jan (month)PMID28681988doi:10.1111/dom.13053via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.