Are early and late cardiovascular risk markers in women with Polycystic Ovary Syndrome increased with concomitant Nonalcoholic Steatohepatitis and can this be modified with Liraglutide?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015927-94-GB

Enrollment

Registered

2010-03-17

Start date

2010-02-08

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Polycystic Ovary Syndrome Non-alcoholic Steatohepatitis MedDRA version: 12.0 Level: LLT Classification code 10065161 Term: Polycystic ovarian syndrome MedDRA version: 12.0 Level: LLT Classification code 10053219 Term: Non-alcoholic steatohepatitis

Interventions

Trade Name: Victoza Pharmaceutical Form: Solution for injection INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For PCOS: Polycystic ovary syndrome (defined by the Rotterdam criteria as 2 out of 3 of: 1. oligo/anovulation 2. clinical or biochemical evidence of hirsuitism, and/or 3. polycystic ovaries on ultrasound. and exclusion of other disorders Age 18-45 years For NASH: Patients with confirmed NASH Female Age 18-45 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Ketoacidosis Severe gastrointestinal disease Hypothyroidism Subjects taking regular prescribed medication Not using a reliable method on contraception (eg barrier/oral contraceptive pill) Patients not allowing disclosure to their GP’s. History of pancreatitis Heart Failure Chronic renal failure (creatinine clearance less than 60 ml/min or plasma creatinine >150 umol/L) Pregnancy or breastfeeding women Liver function tests >300% reference range normal (eg ALT>90 u/mL) Type 2 Diabetes Mellitus Acute conditions with the potential to alter renal function such as: a. dehydration b. severe infection c. shock d. intravascular administration of iodinated contrast

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To show that intervention with Liraglutide significantly improves insulin resistance (an adverse cardiovascular risk marker) 2. To determine if Metformin therapy maintains insulin resistance and markers of PCOS after treatment with Liraglutide. ; Secondary Objective: 1. To show that intervention with Liraglutide significantly improves endothelial function (Early manifestation of cardiovascular disease) in subjects with Polycystic Ovary Syndrome (PCOS) and Nonalcoholic Steatohepatitis (NASH) 2. To determine if Liraglutide therapy significantly improves fibrin clot structure and function (Late manifestation of cardiovascular disease) in subjects with PCOS and NASH. 3. To determine if Liraglutide is effective in reducing steatohepatitis by Fibroscan and reduces the markers of liver fibrosis ;Primary end point(s): This study will demonstrate if the combination of PCO and NASH are additive for cardiovascular risk and whether Liraglutide may modify this. The study will demonstrate if Metformin maintains the modification of the cardiovascular risk after 6 months treatment of Liragltuide.	—

Measure

Time frame

Main Objective: 1. To show that intervention with Liraglutide significantly improves insulin resistance (an adverse cardiovascular risk marker) 2. To determine if Metformin therapy maintains insulin resistance and markers of PCOS after treatment with Liraglutide. ; Secondary Objective: 1. To show that intervention with Liraglutide significantly improves endothelial function (Early manifestation of cardiovascular disease) in subjects with Polycystic Ovary Syndrome (PCOS) and Nonalcoholic Steatohepatitis (NASH) 2. To determine if Liraglutide therapy significantly improves fibrin clot structure and function (Late manifestation of cardiovascular disease) in subjects with PCOS and NASH. 3. To determine if Liraglutide is effective in reducing steatohepatitis by Fibroscan and reduces the markers of liver fibrosis ;Primary end point(s): This study will demonstrate if the combination of PCO and NASH are additive for cardiovascular risk and whether Liraglutide may modify this. The study will demonstrate if Metformin maintains the modification of the cardiovascular risk after 6 months treatment of Liragltuide.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026