Recent Updates
Recently added Catalysts

Zagotenemab

Phase 2

Alzheimer Disease (AD) | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Aug 30, 2022

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment360

FDA Designations

No designations recorded

Clinical trial landscape

Zagotenemab · 1 trial · 1 indication

Phase 2 1
NCT03518073A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's DiseaseAlzheimer Disease (AD)
COMPLETED360 Analytics
PHASE2COMPLETED
A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease (AD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
Baseline, Week 104

Integrated Alzheimer's Disease Rating Scale (iADRS) is a simple linear combination of scores from 13-item alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer's disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). It is used to assess whether zagotenemab slows down the cognitive and functional decline associated with early symptomatic Alzheimer's Disease, compared to placebo. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance and higher score better performance. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval.

Secondary Endpoints

Change From Baseline on the Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score
Baseline, Week 104
Change From Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score
Baseline, Week 104
Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score
Baseline, Week 104
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants received intravenous (IV) infusion of placebo once every four weeks (Q4W) for 100 weeks.
Zagotenemab 1400 mgEXPERIMENTALParticipants received IV infusion of 1400 milligram (mg) zagotenemab Q4W for 100 weeks.
Zagotenemab 5600 mgEXPERIMENTALParticipants received IV infusion of 5600 mg zagotenemab Q4W for 100 weeks.

Interventions

NameTypeDescription
ZagotenemabDRUGAdministered IV
PlaceboDRUGAdministered IV
Unlock Study Design Details

Eligibility Criteria

Age Range60 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites60

Inclusion Criteria: * Participants must have gradual and progressive change in memory function for \>6 months. * Participants must have a family member or close friend who is with you at least 10 hours per week and can attend study appointments. Exclusion Criteria: * Participants must not have si...

Countries:United StatesCanadaJapan
Unlock Eligibility Criteria

Frequently asked questions about Zagotenemab

What is Zagotenemab used for?

Zagotenemab is an investigational small molecule being studied for the treatment of early symptomatic Alzheimer's Disease (AD). It is being developed by Eli Lilly and Company and is currently in Phase 2 clinical development.

What does Zagotenemab target?

Zagotenemab is a small molecule being studied for Alzheimer's Disease. The specific molecular target of Zagotenemab has not been disclosed in the available information.

Who makes Zagotenemab?

Zagotenemab is being developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY.

What phase is Zagotenemab in?

Zagotenemab is in Phase 2 clinical development for Alzheimer's Disease. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is Zagotenemab in?

Zagotenemab has one completed Phase 2 clinical trial, identified as NCT03518073, which studied the drug in participants with early symptomatic Alzheimer's Disease. The trial enrolled 360 participants and was conducted in the United States, Canada, and Japan.

Is Zagotenemab the same as LY3303560?

Yes, Zagotenemab is also known as LY3303560. The clinical trial NCT03518073, which studied Zagotenemab, is titled 'A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease'.