Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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The purpose of the study was to evaluate whether LIK066 can be developed for the treatment of polycystic ovary syndrome (PCOS) in overweight and obese women.

Official Title
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A Randomized, Subject- and Investigator-blinded, Placebo-controlled Pharmacodynamic Study of Oral LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: LIK066
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: PCOS (diagnosed as clinical or biochemical hyperandrogenism, amenorrhea or oligomenorrhea and exclusion of other causes of hyperandrogenism. Overweight/obese female subjects with BMI of 28 - 45 kg/m^2, inclusive, and stable weight +/- 3 kg over previous 3 months Subjects must use non-hormonal methods of contraception during the study. Key Exclusion Criteria: Subjects with exogenous causes of hirsutism Menstruation in the 30 days prior to screening or treatment Pregnant or nursing (lactating) women Use of prohibited medications Preexisting medical condition which may significantly alter the absorption, metabolism, or excretion of the study drug, or which may jeopardize the subject in case of participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIK066<br>LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test | Drug: LIK066<br>* LIK066 tablets for oral administration<br>|
| Placebo Comparator: Placebo<br>Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test | Drug: Placebo<br>* Placebo tablets matching LIK066 tablets, for oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline |  | Baseline, Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Luteinizing Hormone (LH) at Day 15 |  | Baseline, Day 15 | 
| Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15 |  | Baseline, Day 15 | 
| Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15 |  | Baseline, Day 15 | 
| Change From Baseline in Androstenedione at Day 15 |  | Baseline, Day 15 | 
| Change From Baseline in Dehydroepiandrostenedione (DHEA) at Day 15 |  | Baseline, Day 15 | 
| Change From Baseline in Dehydroepiandrostenedione Sulfate (DHEAS) at Day 15 |  | Baseline, Day 15 | 
| Change From Baseline in Total Testosterone, at Day 15 |  | Baseline, Day 15 | 
| Change From Baseline in Free Androgen Index (FAI), at Day 15 | Free Androgen Index (FAI) is a ratio used to determine abnormal androgen status in humans. The ratio is the total testosterone level divided by the sex hormone binding globulin (SHBG) level, and then multiplying by 100. FAI has no units. | Baseline, Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic ovary syndrome, PCOS, hyperandrogenism, insulin resistance, overweight, obesity