Phase 2
Completed N=29
Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
Source: ClinicalTrials.gov NCT03152591 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline — 0.91; 1.03 nmol/L — p=0.353
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline |
0.91; 1.03 | 0.353 |
| SECONDARY Change From Baseline in Luteinizing Hormone (LH) at Day 15 |
1.37; 1.10 | 0.218 |
| SECONDARY Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15 |
1.13; 0.89 | 0.249 |
| SECONDARY Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15 |
1.06; 0.93 | 0.173 |
| SECONDARY Change From Baseline in Androstenedione at Day 15 |
0.85; 1.03 | 0.089 |
| SECONDARY Change From Baseline in Dehydroepiandrostenedione (DHEA) at Day 15 |
0.75; 1.09 | 0.109 |
| SECONDARY Change From Baseline in Dehydroepiandrostenedione Sulfate (DHEAS) at Day 15 |
0.84; 1.10 | 0.008 sig |
| SECONDARY Change From Baseline in Total Testosterone, at Day 15 |
0.95; 1.04 | 0.340 |
| SECONDARY Change From Baseline in Free Androgen Index (FAI), at Day 15 |
0.85; 1.07 | 0.204 |
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
Data sourced from ClinicalTrials.gov (NCT03152591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.