NCT03152591

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_2

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 24, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 9, 2019

Completed
Last Updated

January 5, 2021

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

May 11, 2017

Results QC Date

March 28, 2019

Last Update Submit

December 9, 2020

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndromePCOShyperandrogenisminsulin resistanceoverweightobesity

Outcome Measures

Primary Outcomes (1)

  • Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline

    Baseline, Day 15

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

LIK066

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

LIK066DRUG

LIK066 tablets for oral administration

LIK066
PlaceboDRUG

Placebo tablets matching LIK066 tablets, for oral administration

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Novartis Investigative Site

Springfield, Missouri, 65802, United States

Location

Novartis Investigative Site

Philadelphia, Pennsylvania, 19104, United States

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Related Links

MeSH Terms

Conditions

Polycystic Ovary SyndromeHyperandrogenismInsulin ResistanceOverweightObesity

Interventions

licogliflozin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 15, 2017

Study Start

July 24, 2017

Primary Completion

June 25, 2018

Study Completion

June 25, 2018

Last Updated

January 5, 2021

Results First Posted

May 9, 2019

Record last verified: 2020-09

Locations

DE(3)US(2)