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

A Randomized, Subject- and Investigator-blinded, Placebo-controlled Pharmacodynamic Study of Oral 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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: LIK066; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Novartis Investigative Site
  • Essen, Germany, 45147
    • Novartis Investigative Site
  • Freiburg, Germany, 79106
    • Novartis Investigative Site
• United States
  • Missouri
    • Springfield, Missouri, United States, 65802
      • Novartis Investigative Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LIK066; LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test	Drug: LIK066; LIK066 tablets for oral administration
Placebo Comparator: Placebo; Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test	Drug: Placebo; Placebo tablets matching LIK066 tablets, for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline	Baseline, Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Sex Hormone Binding Globulin (SHBG) at Day 15		Baseline, Day 15
Change From Baseline in Androstenedione at Day 15		Baseline, Day 15
Change From Baseline in Dehydroepiandrostenedione (DHEA) 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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2017
• Primary Completion (Actual): June 25, 2018
• Study Completion (Actual): June 25, 2018

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: obesity; overweight; PCOS; insulin resistance; Polycystic ovary syndrome; hyperandrogenism
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Body Weight; Polycystic Ovary Syndrome; Syndrome; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Licogliflozin
• Other Study ID Numbers: CLIK066X2205; 2017-001373-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No