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Nimacimab

Phase 2

Obesity | Monoclonal antibody | Metabolic |Skye Bioscience, Inc.|Last Updated: Jan 14, 2026

Target and mechanism

Molecular targetCNR1
Target classNegative Allosteric Modulator
ModalityMonoclonal antibody

Also known as Nimacimab injection

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment136

FDA Designations

No designations recorded

Clinical trial landscape

Nimacimab · 1 trial · 1 indication

Phase 2 1
NCT06577090Study to Evaluate the Effect on Obesity of QW Nimacimab and QW Nimacimab Co-administered With Semaglutide vs PlaceboObesity
ACTIVE NOT_RECRUITING136 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study to Evaluate the Effect on Obesity of QW Nimacimab and QW Nimacimab Co-administered With Semaglutide vs Placebo
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent change in body weight (main study)
From Baseline to Week 26

Percent of participants who have a reduction in body weight

Nature, frequency and severity of AEs (study extension)
Baseline through Week 38 of study extension (approximately 10 months of participation)

Nature, frequency and severity of treatment-emergent adverse events, including serious adverse events and adverse events of special interest

Secondary Endpoints

Change in body weight (main study)
From Baseline to Week 26
Change in waist circumference (main study)
From Baseline to Week 26
Change in waist circumference (study extension)
From baseline to Week 26 of study extension (approximately 7 months of participation)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Nimacimab injectionEXPERIMENTALNimacimab injection 200 mg
Nimacimab placebo injectionPLACEBO_COMPARATORMatching nimacimab placebo injection
Semaglutide injection + Nimacimab injection 200 mgEXPERIMENTALSemaglutide injection administered according to dose escalation described in semaglutide prescribing information plus concomitant administration of Nimacimab Injection 200 mg
Semaglutide injection + Nimacimab placebo injectionACTIVE_COMPARATORSemaglutide 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)EXPERIMENTALWeekly nimacimab injection 300 mg open-label (study extension)

Interventions

NameTypeDescription
Nimacimab injectionBIOLOGICALNimacimab injection 200 mg
Nimacimab placebo injectionBIOLOGICALmatching nimacimab placebo injection
semaglutide injectionCOMBINATION_PRODUCTsemaglutide injection 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg + nimacimab 200 mg
Nimacimab 300 mg injectionBIOLOGICALNimacimab injection 300 mg
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites16

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...

Countries:United States
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Frequently asked questions about Nimacimab

What is Nimacimab used for in obesity?

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.

What does Nimacimab target?

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.

Who is developing Nimacimab?

Nimacimab is being developed by Skye Bioscience, Inc., a biopharmaceutical company. Skye Bioscience's stock is traded under the ticker symbol SKYE.

What phase is Nimacimab in?

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.

What clinical trials is Nimacimab in?

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.

Is Nimacimab the same as Nimacimab injection?

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.