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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02073929
Acronym
LIPT
Enrollment
72
Registered
2014-02-28
Start date
2014-03-31
Completion date
2015-12-31
Last updated
2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Polycystic Ovary Syndrome

Brief summary

Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated with metabolic syndrom, diabetes and and increased risk og cardiovascular disease. The study investigates the effect af intervention with GLP-1-analog on risk markers of cardiovascular disease in women with PCOS. 70 women will be included in af RCT. Hypothesis: GLP-1-analog treatment in women with PCOS (without diabetes) will result in a beneficial reduction in risk markers of vascular thrombosis and early cardiovascular disease.

Interventions

DRUGLiraglutide for 26 weeks

GLP-1-analogue Liraglutide s.c. 1,8mg daily for 26 weeks

DRUGplacebo

Placebo s.c. daily for 26 weeks

Sponsors

Jens Faber
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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 * ...

Design outcomes

Primary

MeasureTime frameDescription
Change in Endogenous Thrombin Potential (ETP)at time 0 and 26 weeksArea under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min

Secondary

MeasureTime frame
Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1at time 0 and 26 weeks

Other

MeasureTime frameDescription
Change in Plasma Level of Copeptinat time 0 and 26 weeks—
Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)at time 0 and 26 weekspercent change from baseline
Change in Bleeding Pattern (Bleeding Ratio)at time 0 and 26 weeksRation between number of bleedings during 3 months before trial and last 3 months of trial
Change in Plasma Level of Adrenomedullinat time 0 and 26 weeksmeasured in nmol/l
Change in Body Composition (VAT)at time 0 and 26 weekscubic cm
Change in Ovarian Volume Between Baseline and Follow up (26 Weeks)at time 0 and 26 weeksmeasured as ml
Change in Serum Levels of Anti-Müllerian Hormoneat time 0 and 26 weeksmeasured as pmol/l
Change in Percent Liver Fat Contentat time 0 and 26 weekspercent liver fat content
Change in Plasma Level of Atrial Natriuretic Peptide (ANP)at time 0 and 26 weeksmeasured in pmol/l

Countries

Denmark

Participant flow

Participants by arm

ArmCount
Liraglutide
Liraglutide
48
Placebo
Placebo
24
Total72

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event21
Overall StudyLost to Follow-up21
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicLiraglutidePlaceboTotal
Age, Continuous31.4 years26.2 years29.9 years
BMI33.3 kg/m2
STANDARD_DEVIATION 5.1
33.3 kg/m2
STANDARD_DEVIATION 4.6
33.3 kg/m2
STANDARD_DEVIATION 4.9
Endogenous Thrombin Potential1796 micromol/l x min
STANDARD_DEVIATION 332
1830 micromol/l x min
STANDARD_DEVIATION 285
1801 micromol/l x min
STANDARD_DEVIATION 324
Race/Ethnicity, Customized
caucasians
45 Participants22 Participants67 Participants
Race/Ethnicity, Customized
other ethnicity
3 Participants2 Participants5 Participants
Sex/Gender, Customized
women
48 Participants24 Participants72 Participants
Total testosterone1.23 nmol/l1.35 nmol/l1.30 nmol/l
Waist Circumference102.6 cm
STANDARD_DEVIATION 10.8
102.6 cm
STANDARD_DEVIATION 11.1
102.6 cm
STANDARD_DEVIATION 11

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
37 / 483 / 24
serious
Total, serious adverse events
2 / 481 / 24

Outcome results

Primary

Change in Endogenous Thrombin Potential (ETP)

Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min

Time frame: at time 0 and 26 weeks

ArmMeasureValue (MEAN)
LiraglutideChange in Endogenous Thrombin Potential (ETP)-56.7 nMolar x minutes
PlaceboChange in Endogenous Thrombin Potential (ETP)-8.2 nMolar x minutes
Secondary

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

Time frame: at time 0 and 26 weeks

ArmMeasureValue (MEAN)
LiraglutidePercent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1-12 percent change in plasma PAI-1
PlaceboPercent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-14 percent change in plasma PAI-1
Other Pre-specified

Change in Bleeding Pattern (Bleeding Ratio)

Ration between number of bleedings during 3 months before trial and last 3 months of trial

Time frame: at time 0 and 26 weeks

ArmMeasureValue (MEDIAN)
LiraglutideChange in Bleeding Pattern (Bleeding Ratio)0.28 n of bleedings/n of expected bleedings
PlaceboChange in Bleeding Pattern (Bleeding Ratio)0.14 n of bleedings/n of expected bleedings
Other Pre-specified

Change in Body Composition (VAT)

cubic cm

Time frame: at time 0 and 26 weeks

Population: not measured on all subjects (missing. 4 in Liraglutide and one in placebo Group)

ArmMeasureValue (MEAN)Dispersion
LiraglutideChange in Body Composition (VAT)-17 cubic cmStandard Deviation 4
PlaceboChange in Body Composition (VAT)5 cubic cmStandard Deviation 7
Other Pre-specified

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

measured as ml

Time frame: at time 0 and 26 weeks

Population: not measured in all participants, one is missing in each group

ArmMeasureValue (MEAN)
LiraglutideChange in Ovarian Volume Between Baseline and Follow up (26 Weeks)-2 ml
PlaceboChange in Ovarian Volume Between Baseline and Follow up (26 Weeks)0 ml
Other Pre-specified

Change in Percent Liver Fat Content

percent liver fat content

Time frame: at time 0 and 26 weeks

Population: only participants with measurable i.e. \>5% liver fat at baseline was included in this analysis

ArmMeasureValue (MEAN)Dispersion
LiraglutideChange in Percent Liver Fat Content-1.6 percentage of liver fatStandard Deviation 0.4
PlaceboChange in Percent Liver Fat Content-0.2 percentage of liver fatStandard Deviation 0.7
Other Pre-specified

Change in Plasma Level of Adrenomedullin

measured in nmol/l

Time frame: at time 0 and 26 weeks

ArmMeasureValue (MEDIAN)
LiraglutideChange in Plasma Level of Adrenomedullin-0.02 nmol/l
PlaceboChange in Plasma Level of Adrenomedullin0.003 nmol/l
Other Pre-specified

Change in Plasma Level of Atrial Natriuretic Peptide (ANP)

measured in pmol/l

Time frame: at time 0 and 26 weeks

ArmMeasureValue (MEDIAN)
LiraglutideChange in Plasma Level of Atrial Natriuretic Peptide (ANP)-11.5 pmol/l
PlaceboChange in Plasma Level of Atrial Natriuretic Peptide (ANP)1.4 pmol/l
Other Pre-specified

Change in Plasma Level of Copeptin

Time frame: at time 0 and 26 weeks

Population: measured as pmol/l

ArmMeasureValue (MEDIAN)
LiraglutideChange in Plasma Level of Copeptin0.48 pmol/l
PlaceboChange in Plasma Level of Copeptin0.28 pmol/l
Other Pre-specified

Change in Serum Levels of Anti-Müllerian Hormone

measured as pmol/l

Time frame: at time 0 and 26 weeks

Population: missing one participant in placebo group

ArmMeasureValue (MEAN)
LiraglutideChange in Serum Levels of Anti-Müllerian Hormone-8.7 pmol/ml
PlaceboChange in Serum Levels of Anti-Müllerian Hormone3.5 pmol/ml
Other Pre-specified

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

percent change from baseline

Time frame: at time 0 and 26 weeks

ArmMeasureValue (MEAN)
LiraglutidePercent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)-15 percent change in CRP levels
PlaceboPercent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)-25 percent change in CRP levels

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026