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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001373-16 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIK066 | Drug | LIK066 tablets for oral administration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline | Baseline, Day 15 |
| 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 | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Springfield | Missouri | 65802 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicatrials.com | View source |
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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
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Participants were randomized in the ratio of 1:1 to receive either LIK066 50 mg tid or placebo for 14 days and morning dose on Day 15.
This study was conducted in 5 centers in 2 countries: Germany (3), and USA (2).
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| ID | Title | Description |
|---|---|---|
| FG000 | LIK066 | LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test |
| FG001 | Placebo | Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LIK066 | LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test |
| BG001 | Placebo | Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline | Pharmacodynamic (PD) analysis set | Posted | Geometric Mean | 90% Confidence Interval | nmol/L | Baseline, Day 15 |
|
Adverse Events were collected for the maximum duration of participants' treatment exposure plus any follow up period, approximately 2 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LIK066 | LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 3, 2017 | Mar 28, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 20, 2017 | Mar 28, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D017588 | Hyperandrogenism |
| D007333 | Insulin Resistance |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| C000709456 | licogliflozin |
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| Drug |
Placebo tablets matching LIK066 tablets, for oral administration |
|
| 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 |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Number | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Average fasting total testosterone | Mean | Standard Deviation | nmol/L |
|
| Average fasting free testosterone | Mean | Standard Deviation | nmol/L |
|
| Sex hormone binding globulin (SHBG) | Mean | Standard Deviation | nmol/L |
|
| Free androgen Index | 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. | Mean | Standard Deviation | ratio |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Change From Baseline in Luteinizing Hormone (LH) at Day 15 | Pharmacodynamic (PD) analysis set | Posted | Geometric Mean | 90% Confidence Interval | U/L | Baseline, Day 15 |
|
|
|
|
| Secondary | Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15 | Pharmacodynamic (PD) analysis set | Posted | Geometric Mean | 90% Confidence Interval | U/L | Baseline, Day 15 |
|
|
|
|
| Secondary | Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15 | Pharmacodynamic (PD) analysis set | Posted | Geometric Mean | 90% Confidence Interval | nmol/L | Baseline, Day 15 |
|
|
|
|
| Secondary | Change From Baseline in Androstenedione at Day 15 | Pharmacodynamic (PD) analysis set | Posted | Geometric Mean | 90% Confidence Interval | nmol/L | Baseline, Day 15 |
|
|
|
|
| Secondary | Change From Baseline in Dehydroepiandrostenedione (DHEA) at Day 15 | Pharmacodynamic (PD) analysis set | Posted | Geometric Mean | 90% Confidence Interval | nmol/L | Baseline, Day 15 |
|
|
|
|
| Secondary | Change From Baseline in Dehydroepiandrostenedione Sulfate (DHEAS) at Day 15 | Pharmacodynamic (PD) analysis set | Posted | Geometric Mean | 90% Confidence Interval | umol/L | Baseline, Day 15 |
|
|
|
|
| Secondary | Change From Baseline in Total Testosterone, at Day 15 | Pharmacodynamic (PD) analysis set | Posted | Geometric Mean | 90% Confidence Interval | nmol/L | 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. | Pharmacodynamic (PD) analysis set | Posted | Geometric Mean | 90% Confidence Interval | Ratio | Baseline, Day 15 |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 15 |
| 15 |
| EG001 | Placebo | Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test | 0 | 14 | 0 | 14 | 10 | 14 |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| GASTROINTESTINAL TRACT IRRITATION | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| THIRST | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| VAGINAL INFECTION | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| VULVOVAGINAL MYCOTIC INFECTION | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| MENSTRUATION NORMAL | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| MUSCULOSKELETAL DISCOMFORT | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| MIGRAINE | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| MOOD ALTERED | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| POLYURIA | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| HYPOMENORRHOEA | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| MENSTRUAL DISORDER | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| DRY THROAT | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D058489 | 46, XX Disorders of Sex Development |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D047808 | Adrenogenital Syndrome |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |