Clinical trial · Interventional
Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
A Randomized, Subject- and Investigator-blinded, Placebo-controlled Pharmacodynamic Study of Oral LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
NCT03152591CI-TRIAL-00049245PCOScompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LIK066 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LIK066
- description
- LIK066 tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
- interventionNames
- Drug: LIK066
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo tablets received three times daily; before breakfast, lunch and dinner for 14 days and once on day 15 morning before meal test
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.