Investor Presentaiton
SELECT TRIALS - DONANEMAB
Lilly
Study
Indication*
Title
Phase Patients
Primary Outcome**
Primary
Completion
Completion
Mild
NCT05108922 Cognitive
Impairment
A Study of Donanemab (LY3002813) Compared With
Aducanumab in Participants With Early Symptomatic
Alzheimer's Disease (TRAILBLAZER-ALZ 4)
3
200
Percentage of Participants Who Reach Complete Amyloid
Plaque Clearance on Florbetapir F18 Positron Emission
Tomography (PET) Scan (Superiority) on donanemab
versus aducanumab
Sep 2022
Sep 2023
NCT04437511
Alzheimer A Study of Donanemab (LY3002813) in Participants With
Disease Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
3
1800
Change from Baseline on the integrated Alzheimer's
Disease Rating Scale (iADRS)
Apr 2023
Aug 2025
NCT04640077
Alzheimer
Disease
A Follow-On Study of Donanemab (LY3002813) With Video
Assessments in Participants With Alzheimer's Disease
(TRAILBLAZER-EXT)
2
90
Part A: Correlation between VTC and on-site assessment
for PAIR 1 for Alzheimer's Disease Assessment Scale -
Cognitive Subscale (ADAS-Cog13)
Mar 2024
Mar 2024
NCT05738486
Alzheimer
Disease
A Study of Different Donanemab (LY3002813) Dosing
Regimens in Adults With Early Alzheimer's Disease
(TRAILBLAZER-ALZ 6)
3
800
Percentage of Participants with Any Occurrence of
Amyloid-Related Imaging Abnormality-Edema/Effusion
Mar 2024
May 2025
(ARIA-E)
NCT05508789
Alzheimer
Disease
NCT05026866
Alzheimer
Disease
Study of Donanemab (LY3002813) in Participants With
Early Symptomatic Alzheimer's Disease
(TRAILBLAZER-ALZ 5)
A Donanemab (LY3002813) Prevention Study in
Participants With Alzheimer's Disease (TRAILBLAZER-ALZ
3)
3
1500
Change from Baseline on the Integrated Alzheimer's
Disease Rating Scale (iADRS)
Apr 2027
Jun 2027
3
3300
Time to clinical progression as measured by Clinical
Dementia Rating - Global Score (CDR-GS)
Oct 2027
Nov 2027
* Molecule may have multiple indications
** Trial may have additional primary and other secondary outcomes
Not for promotional use
Source: clinicaltrials.gov, July 20, 2023
2023 Q2 EARNINGS
38
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