Trial · NCT03152591
Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
NCT03152591, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2019-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome. Trials, record NCT03152591. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03152591
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
- NCT number
- NCT03152591
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- LIK066, Placebo
- First posted
- 2017-05-15
- Last updated
- 2021-01-05
- Other registries' IDs
- eudract:2017-001373-16
- Results first posted
- 2019-05-09
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline | Baseline, Day 15 | |
| Secondary | Change From Baseline in Luteinizing Hormone (LH) at Day 15 | Baseline, Day 15 | |
| Secondary | Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15 | Baseline, Day 15 | |
| Secondary | Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15 | Baseline, Day 15 | |
| Secondary | Change From Baseline in Androstenedione at Day 15 | Baseline, Day 15 | |
| Secondary | Change From Baseline in Dehydroepiandrostenedione (DHEA) at Day 15 | Baseline, Day 15 | |
| Secondary | Change From Baseline in Dehydroepiandrostenedione Sulfate (DHEAS) at Day 15 | Baseline, Day 15 | |
| Secondary | Change From Baseline in Total Testosterone, at Day 15 | Baseline, Day 15 | |
| Secondary | Change From Baseline in Free Androgen Index (FAI), at Day 15 | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline | Baseline, Day 15 | Pharmacodynamic (PD) analysis set | nmol/L | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Luteinizing Hormone (LH) at Day 15 | Baseline, Day 15 | Pharmacodynamic (PD) analysis set | U/L | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15 | Baseline, Day 15 | Pharmacodynamic (PD) analysis set | U/L | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15 | Baseline, Day 15 | Pharmacodynamic (PD) analysis set | nmol/L | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Androstenedione at Day 15 | Baseline, Day 15 | Pharmacodynamic (PD) analysis set | nmol/L | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Dehydroepiandrostenedione (DHEA) at Day 15 | Baseline, Day 15 | Pharmacodynamic (PD) analysis set | nmol/L | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Dehydroepiandrostenedione Sulfate (DHEAS) at Day 15 | Baseline, Day 15 | Pharmacodynamic (PD) analysis set | umol/L | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Total Testosterone, at Day 15 | Baseline, Day 15 | Pharmacodynamic (PD) analysis set | nmol/L | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Free Androgen Index (FAI), at Day 15 | Baseline, Day 15 | Pharmacodynamic (PD) analysis set | Ratio | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline | LIK066 | 0.91 | 90% Confidence Interval 0.77 to 1.07 | nmol/L | |
| Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline | Placebo | 1.03 | 90% Confidence Interval 0.88 to 1.21 | nmol/L | |
| Change From Baseline in Luteinizing Hormone (LH) at Day 15 | LIK066 | 1.37 | 90% Confidence Interval 1.11 to 1.69 | U/L | |
| Change From Baseline in Luteinizing Hormone (LH) at Day 15 | Placebo | 1.10 | 90% Confidence Interval 0.89 to 1.36 | U/L | |
| Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15 | LIK066 | 1.13 | 90% Confidence Interval 0.89 to 1.43 | U/L | |
| Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15 | Placebo | 0.89 | 90% Confidence Interval 0.70 to 1.13 | U/L | |
| Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15 | LIK066 | 1.06 | 90% Confidence Interval 0.95 to 1.20 | nmol/L | |
| Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15 | Placebo | 0.93 | 90% Confidence Interval 0.83 to 1.03 | nmol/L | |
| Change From Baseline in Androstenedione at Day 15 | LIK066 | 0.85 | 90% Confidence Interval 0.74 to 0.97 | nmol/L | |
| Change From Baseline in Androstenedione at Day 15 | Placebo | 1.03 | 90% Confidence Interval 0.91 to 1.17 | nmol/L |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LIK066 | 15 | |
| Overall Study | STARTED | Placebo | 14 | |
| Overall Study | Pharmacokinetic (PK) Analysis Set | LIK066 | 14 | |
| Overall Study | Pharmacokinetic (PK) Analysis Set | Placebo | 0 | |
| Overall Study | Pharmacodynamic (PD) Analysis Set | LIK066 | 15 | |
| Overall Study | Pharmacodynamic (PD) Analysis Set | Placebo | 14 | |
| Overall Study | COMPLETED | LIK066 | 15 | |
| Overall Study | COMPLETED | Placebo | 14 | |
| Overall Study | NOT COMPLETED | LIK066 | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | LIK066 | 2 | 15 | |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Placebo | 0 | 14 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | LIK066 | 2 | 15 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Placebo | 0 | 14 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | LIK066 | 1 | 15 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Placebo | 0 | 14 | |
| other | DIARRHOEA | Gastrointestinal disorders | LIK066 | 15 | 15 | |
| other | DIARRHOEA | Gastrointestinal disorders | Placebo | 3 | 14 | |
| other | DYSPEPSIA | Gastrointestinal disorders | LIK066 | 1 | 15 | |
| other | DYSPEPSIA | Gastrointestinal disorders | Placebo | 0 | 14 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LIK066 | 0 | 15 |
| Total, all-cause mortality | Placebo | 0 | 14 |
| Total, other adverse events | LIK066 | 15 | 15 |
| Total, other adverse events | Placebo | 10 | 14 |
| Total, serious adverse events | LIK066 | 0 | 15 |
| Total, serious adverse events | Placebo | 0 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| LIK066 vs Placebo: deaths from any cause | Trial comparisons |
| LIK066 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03152591
GET https://conductscience.org/api/trials/v1/NCT03152591/events?page=2