Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Nimacimab injection
Nimacimab · 1 trial · 1 indication
Percent of participants who have a reduction in body weight
Nature, frequency and severity of treatment-emergent adverse events, including serious adverse events and adverse events of special interest
| Arm | Type | Description |
|---|---|---|
| Nimacimab injection | EXPERIMENTAL | Nimacimab injection 200 mg |
| Nimacimab placebo injection | PLACEBO_COMPARATOR | Matching nimacimab placebo injection |
| Semaglutide injection + Nimacimab injection 200 mg | EXPERIMENTAL | Semaglutide injection administered according to dose escalation described in semaglutide prescribing information plus concomitant administration of Nimacimab Injection 200 mg |
| Semaglutide injection + Nimacimab placebo injection | ACTIVE_COMPARATOR | Semaglutide injection administered according to dose escalation described in semaglutide Prescribing Information plus concomitant administration of Nimacimab Injection or matching placebo injection |
| Open-label 300 mg Nimacimab injection (study extension) | EXPERIMENTAL | Weekly nimacimab injection 300 mg open-label (study extension) |
| Name | Type | Description |
|---|---|---|
| Nimacimab injection | BIOLOGICAL | Nimacimab injection 200 mg |
| Nimacimab placebo injection | BIOLOGICAL | matching nimacimab placebo injection |
| semaglutide injection | COMBINATION_PRODUCT | semaglutide injection 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg + nimacimab 200 mg |
| Nimacimab 300 mg injection | BIOLOGICAL | Nimacimab injection 300 mg |
Inclusion Criteria: 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which...
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Nimacimab is an investigational monoclonal antibody being developed for the treatment of obesity. It is currently in Phase 2 clinical development and is being studied as a weekly injection, both alone and in combination with semaglutide, to evaluate its effect on obesity.
Nimacimab targets the CNR1 receptor, also known as the cannabinoid receptor type 1. It acts as a negative allosteric modulator of this receptor, meaning it binds to a site distinct from the active site and reduces the receptor's activity.
Nimacimab is being developed by Skye Bioscience, Inc., a biopharmaceutical company. Skye Bioscience's stock is traded under the ticker symbol SKYE.
Nimacimab is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy for the treatment of obesity.
Nimacimab is being evaluated in a Phase 2 clinical trial with the identifier NCT06577090. This randomized, double-blind, placebo-controlled study is assessing the effect of weekly Nimacimab, both alone and co-administered with semaglutide, versus placebo in 136 participants with obesity in the United States.
Yes, Nimacimab injection is another name for Nimacimab. The drug is administered as an injection, and this alternative name is used to describe the formulation being tested in clinical trials.