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

Novartis

Status and phase: Completed; Phase 2

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Placebo; Drug: LIK066

Study type: Interventional

Funder types: Industry

Identifiers

NCT03152591

2017-001373-16 (EudraCT Number)

CLIK066X2205

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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29 participants in 2 patient groups, including a placebo group

LIK066

Experimental group

Description:

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

Treatment:

Drug: LIK066

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo