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Also known as Liraglutide Pen Injector [Saxenda]
Liraglutide Pen Injector · 1 trial · 3 indications
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 ...
Liraglutide Pen Injector is being studied in pre diabetes, a condition of elevated blood glucose that has not yet reached the diabetic range. It is also known as Saxenda. The Phase 3 trial NCT03480022 evaluated it in obese women with polycystic ovary syndrome who had pre diabetes, obesity and android fat distribution.
Liraglutide Pen Injector targets GLP1R, the glucagon-like peptide-1 receptor, and acts as an agonist at that receptor. GLP1R agonism is the mechanism underlying this small molecule's activity in metabolic conditions. The drug is a liraglutide formulation delivered by pen injector.
Liraglutide Pen Injector is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the company behind the liraglutide pen injector product also marketed under the Saxenda name.
Liraglutide Pen Injector is in Phase 3 development. It is an investigational asset in clinical development and is not described here as approved. The Phase 3 study supporting this stage has been completed.
Liraglutide Pen Injector has been studied in one Phase 3 trial, NCT03480022, titled Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS. That trial is completed, enrolled 88 participants, was randomized, double blind and placebo controlled, and was conducted in the United States in women aged 18 years and older.
Yes. Liraglutide Pen Injector is also known as Liraglutide Pen Injector [Saxenda], so Saxenda is the alternative name for this asset. The Phase 3 trial NCT03480022 refers to the treatment as liraglutide 3mg (Saxenda).