A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
← catalyst calendarSponsored by Eli Lilly and Company (industry) · LLY — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
1,736actual
Sites
274
Countries
Australia, Canada, Czechia +6
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-06-19 | actual | When the study began enrolling |
| Primary completion | 2023-04-14 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2020-06-18 | actual | When this record first appeared on the registry |
| Results posted | 2024-05-20 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-08-29 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Alzheimer Disease
Interventions
- Drug: Donanemab — also filed as LY3002813
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFChange From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population)
measured Baseline, Week 76
Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Intermediate (Low-medium) Tau Population)
measured Baseline, Week 76
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2022-11-10 · 1.3 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-04-20 · 740 KB · SAP_001.pdf
Publications
- PMID 42552749 — linked by the registry
- PMID 42273802 — linked by the registry
- PMID 42128444 — linked by the registry
- PMID 41804324 — linked by the registry
- PMID 41330788 — linked by the registry
- PMID 41082199 — linked by the registry
- PMID 40667684 — linked by the registry
- PMID 40603145 — linked by the registry
- PMID 40063015 — linked by the registry
- PMID 39292433 — linked by the registry
- PMID 38581616 — linked by the registry
- PMID 38323738 — linked by the registry
- PMID 37459141 — linked by the registry
- PMID 36934371 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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