Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03480022 | Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS | PHASE3 | COMPLETED | 88 | — | — | Sep 26, 2018 | May 19, 2021 | Jun 7, 2021 | 1 | United States |
Treatment impact on change in body weight after 32 weeks of treatment.
Drug treatment effect on free androgen levels as calculated as FAI= total testosterone (T) concentrations divided by sex hormone binding globulin (SHBG) levels. A higher score indicates a worse outcome (more androgenic).
| Arm | Type | Description |
|---|---|---|
| Liraglutide Pen Injector (Saxenda) | EXPERIMENTAL | Start injection liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg liraglutide SQ daily |
| Placebo liraglutide pen injector | PLACEBO_COMPARATOR | Start injection of placebo liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg placebo liraglutide SQ daily |
| Name | Type | Description |
|---|---|---|
| Liraglutide Pen Injector [Saxenda] | DRUG | daily sc injection of liraglutide with final dose of 3mg daily |
| Placebo Liraglutide Pen Injector | DRUG | daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo |
Inclusion Criteria: * Female gender * 18-45 years of age * BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with one or more obesity-associated co-morbid conditions (e.g. hypertension, and dyslipidemia) * PCOS- NIH criteria hyperandrogenism and irregular menstrual cyclicity * Non-diabetic as determined by a 75 gram ...