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

Phase 2

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: LIK066; Drug: Placebo

• Registration Number: NCT03152591
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-15
• Study Start: 2017-07-24
• Primary Completion: 2018-06-25
• Study Completion: 2018-06-25
• Results First Submitted: 2019-03-28
• Results First Submitted QC: 2019-05-08
• Results First Posted: 2019-05-09
• Status Verified: 2020-09
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline	Baseline, Day 15

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15	Baseline, Day 15
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 Dehydroepiandrostenedione (DHEA) at Day 15	Baseline, Day 15
Change From Baseline in Free Androgen Index (FAI), at Day 15	Baseline, 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.
Change From Baseline in Androstenedione 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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Freiburg, Germany