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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LIK066
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, PCOS, hyperandrogenism, insulin resistance, overweight, obesity

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LIK066

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline

Secondary Outcome Measures

Change From Baseline in Luteinizing Hormone (LH) at Day 15
Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15
Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15
Change From Baseline in Androstenedione at Day 15
Change From Baseline in Dehydroepiandrostenedione (DHEA) at Day 15
Change From Baseline in Dehydroepiandrostenedione Sulfate (DHEAS) at Day 15
Change From Baseline in Total Testosterone, at 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.

Full Information

First Posted
May 11, 2017
Last Updated
December 9, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03152591
Brief Title
Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 24, 2017 (Actual)
Primary Completion Date
June 25, 2018 (Actual)
Study Completion Date
June 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic ovary syndrome, PCOS, hyperandrogenism, insulin resistance, overweight, obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LIK066
Arm Type
Experimental
Arm Description
LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
Intervention Type
Drug
Intervention Name(s)
LIK066
Intervention Description
LIK066 tablets for oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets matching LIK066 tablets, for oral administration
Primary Outcome Measure Information:
Title
Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline
Time Frame
Baseline, Day 15
Secondary Outcome Measure Information:
Title
Change From Baseline in Luteinizing Hormone (LH) at Day 15
Time Frame
Baseline, Day 15
Title
Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15
Time Frame
Baseline, Day 15
Title
Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15
Time Frame
Baseline, Day 15
Title
Change From Baseline in Androstenedione at Day 15
Time Frame
Baseline, Day 15
Title
Change From Baseline in Dehydroepiandrostenedione (DHEA) at Day 15
Time Frame
Baseline, Day 15
Title
Change From Baseline in Dehydroepiandrostenedione Sulfate (DHEAS) at Day 15
Time Frame
Baseline, Day 15
Title
Change From Baseline in Total Testosterone, at Day 15
Time Frame
Baseline, Day 15
Title
Change From Baseline in Free Androgen Index (FAI), at Day 15
Description
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.
Time Frame
Baseline, Day 15

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
Novartis Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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
Links:
URL
https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=423
Description
A Plain Language Trial Summary is available on novartisclinicatrials.com

Learn more about this trial

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

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