Approval Probability
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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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
Liraglutide Pen Injector is being studied for use in pre diabetes, specifically in a Phase 3 clinical trial for obese women with polycystic ovary syndrome (PCOS) who also have pre diabetes and android obesity. The trial evaluates the drug's effects on weight, body composition, hormonal and metabolic parameters.
Liraglutide Pen Injector is a small molecule that targets the GLP-1 receptor, a key regulator of blood sugar and appetite. By activating this receptor, it helps improve glycemic control and promote weight loss, which is relevant for its investigational use in pre diabetes and obesity-related conditions.
Liraglutide Pen Injector is developed by Novo Nordisk A/S, a global healthcare company traded on the New York Stock Exchange under the ticker NVO. The company is conducting clinical research to evaluate the drug's potential in metabolic conditions such as pre diabetes.
Liraglutide Pen Injector is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the studied indication. The Phase 3 trial is completed, with results expected to inform further development decisions.
Liraglutide Pen Injector has one completed Phase 3 trial, NCT03480022, which enrolled 88 female participants in the United States. The study was randomized, double-blind, and placebo-controlled, evaluating the drug in obese women with PCOS, pre diabetes, and android obesity.
Liraglutide Pen Injector is the same as Saxenda, as indicated by the trial title referencing 'Liraglutide 3mg (Saxenda)'. Saxenda is a brand name for liraglutide at a 3 mg dose, which is being studied in this Phase 3 trial for pre diabetes and related conditions.