Phase 4 · Liraglutide

LIPT trial results

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

Change in Endogenous Thrombin Potential (ETP) (nMolar x minutes), at time 0 and 26 weeks. Liraglutide: -56.7; Placebo: -8.2.

Participants
72
Status
completed
Completed
2015-12
Sponsor
Jens Faber

As posted on ClinicalTrials.gov (NCT02073929), updated at source Feb 28, 2019. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What LIPT measured first

Change in Endogenous Thrombin Potential (ETP)nMolar x minutes · at time 0 and 26 weeks · mean
Liraglutiden=48Placebon=24
-56.7(-132.3 to 17.2)-8.2(-98.7 to 82.3)
Side effects by arm

Side effects in LIPT

Percent of participants affected. The most common events the registry lists.

EventActivePlacebo
Any serious event4.2%4.2%
nausea77.1%12.5%
constipation25%0%
vomiting10.4%0%
diarrhea10.4%4.2%
hypotension2.1%0%
Secondary outcomes

What else it measured

Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1percent change in plasma PAI-1 · at time 0 and 26 weeks · mean
Liraglutiden=48Placebon=24
-12(-23 to 0)4(-14 to 26)
The trial

How LIPT was run

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.

  • Active: Liraglutide s.c. 1,8mg daily for 26 weeks
  • Placebo: Placebo s.c. daily for 26 weeks
Who could join the trial

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 * ...

Published papers

Papers from LIPT

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.