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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-24

Study Completion Date

2018-06-25

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.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LIK066

LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test

Group Type EXPERIMENTAL

LIK066

Intervention Type DRUG

LIK066 tablets for oral administration

Placebo

Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets matching LIK066 tablets, for oral administration

Interventions

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LIK066

LIK066 tablets for oral administration

Intervention Type DRUG

Placebo

Placebo tablets matching LIK066 tablets, for oral administration

Intervention Type DRUG

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No