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Completed

NCT Number: NCT03152591

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

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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Key information

Conditions

Polycystic Ovary Syndrome 46, XX Disorders of Sex Development Adnexal Diseases Adrenogenital Syndrome Body Weight Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperandrogenism Hyperinsulinism Insulin Resistance Male Urogenital Diseases Metabolic Diseases Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Abnormalities Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIK066

Drug

LIK066 tablets for oral administration

Placebo

Drug

Placebo tablets matching LIK066 tablets, for oral administration

Primary outcomes

  1. Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline

    Time frame: Baseline, Day 15

Secondary outcomes

  1. Change From Baseline in Luteinizing Hormone (LH) at Day 15

    Time frame: Baseline, Day 15

  2. Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15

    Time frame: Baseline, Day 15

  3. Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15

    Time frame: Baseline, Day 15

  4. Change From Baseline in Androstenedione at Day 15

    Time frame: Baseline, Day 15

  5. Change From Baseline in Dehydroepiandrostenedione (DHEA) at Day 15

    Time frame: Baseline, Day 15

  6. Change From Baseline in Dehydroepiandrostenedione Sulfate (DHEAS) at Day 15

    Time frame: Baseline, Day 15

  7. Change From Baseline in Total Testosterone, at Day 15

    Time frame: Baseline, Day 15

  8. Change From Baseline in Free Androgen Index (FAI), at Day 15

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: PCOS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 15, 2017
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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