iraglutide in the treatment of polycystic ovary syndrome (LIPOS study)

Phase 1

• Conditions: Polycystic ovary syndrome (PCOS).; MedDRA version: 20.0 Level: LLT Classification code 10065161 Term: Polycystic ovarian syndrome System Organ Class: 100000004872; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2012-002073-60-GB
• Lead Sponsor: niversity of Warwick

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-04
• Study Completion: 2016-10-15
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. PCOS diagnosis defined according to all three criteria of the 2003 Rotterdam Consensus Group: (i) Menstrual disorders, either amenorrhoea or less than six menses in the last 12 months; (ii) Clinical or biochemical hyperandrogenism, once secondary causes such as hyperprolactinaemia, Cushing’s syndrome, congenital adrenal hyperplasia have been excluded; (iii) Polycystic ovaries on ultrasound scan
2. Informed consent obtained before any study related activities
3. Body Mass Index (BMI) > 27 kg/m2 and BMI < 45 kg/m2
4. Stable body weight (less than 5 kg self-reported change) during the previous 3 months
5. Age: = 18 years and < 40 years
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 106
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Any clinically significant disease which in the Investigator's opinion could interfere with the safety of study participants or with the results of the study
2. Diagnosis (already documented diagnosis or new diagnosis based on the OGTT results at study visit 2) of Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) or Type 2 Diabetes Mellitus (diagnosis based on the American Diabetes Association criteria on the diagnosis and classification of diabetes mellitus)
3. Previous treatment with GLP-1 receptor agonists (including liraglutide or exenatide) or drugs that affect gastrointestinal motility or carbohydrate metabolism, or lipid-lowering or anti-obesity drugs within the last 3 months
4. Pregnancy, breast-feeding or intention to become pregnant or not using adequate contraceptive methods (adequate contraceptive measures defined as consistent use of barrier methods or true abstinence).
5. Obesity induced by other endocrinological disorders (e.g. Cushing Syndrome). The presence of other endocrinopathies will have been ruled out at the time of PCOS diagnosis.
6. Current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), atypical antipsychotic, tricyclic antidepressants, and mood stabilizers (e.g., amitryptiline, imipramine, mirtazapin, phenelzine, paroxetine, thioridazine, clorpromazine, olanzapine, clozapine, lithium and valproic acid and its derivatives,)
7. Participation in a clinical trial of weight control within the last 3 months prior to screening
8. Current participation in an organised diet reduction programme (or within the last 3 months) and/or are currently using or have used within three months before screening: orlistat, pramlintide, zonisamide, topiramate (either by prescription or as part of a clinical trial)
9. Any intervention that would alter weight and therefore interfere with menstrual cyclicity, such as: (i) Diet attempts using herbal supplements or over-the-counter medications within 3 months before screening; (ii) Previous surgical treatment for obesity (excluding liposuction if performed more than one year before this study)
10. Surgery scheduled for the study duration period, except for minor surgical procedures, at the discretion of the Investigator
11. History of major depressive disorder or history of other severe psychiatric disorders, e.g. schizophrenia or bipolar disorder within the last 2 years
12. Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as TSH > 6 mIU/L or < 0.4 mIU/L, respectively
13. Impaired liver function, defined as ALAT =2.5 times upper limit of normal
14. Impaired renal function defined as serum-creatinine =110 µmol/L (= 1.3 mg/dL) or according to local label for metformin use
15. Known clinically significant active cardiovascular disease, including history of unstable angina, acute coronary event, other significant cardiac events (including history of myocardial infarction, arrhythmias, or conduction delays on electrocardiogram), or cerebral stroke within the last 6 months and/or heart failure (New York Heart Association Class III and IV) at the discretion of the

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified