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

Polycystic Ovary Syndrome Clinical Trial

— PCOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03152591
• Other study ID #: CLIK066X2205
• Secondary ID: 2017-001373-16
• Status: Completed
• Phase: Phase 2
• Start date: July 24, 2017
• Est. completion date: June 25, 2018

Study information

• Verified date: September 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 25, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• LIK066
LIK066 tablets for oral administration
• Placebo
Placebo tablets matching LIK066 tablets, for oral administration

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Freiburg
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline		Baseline, Day 15
Secondary	Change From Baseline in Luteinizing Hormone (LH) at Day 15		Baseline, Day 15
Secondary	Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15		Baseline, Day 15
Secondary	Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15		Baseline, Day 15
Secondary	Change From Baseline in Androstenedione at Day 15		Baseline, Day 15
Secondary	Change From Baseline in Dehydroepiandrostenedione (DHEA) at Day 15		Baseline, Day 15
Secondary	Change From Baseline in Dehydroepiandrostenedione Sulfate (DHEAS) at Day 15		Baseline, Day 15
Secondary	Change From Baseline in Total Testosterone, at Day 15		Baseline, Day 15
Secondary	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

External Links

•   A Plain Language Trial Summary is available on novartisclinicatrials.com