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Phase 1/2 Clinical Trial of LY3884963 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN)

Active, not recruiting · Phase 1, Phase 2 · NCT04408625

Conditions: Frontotemporal Dementia

At a glance

Research payments reported, 2025
$303,696
U.S. investigators named
3
Sites paid
3
Planned or actual enrollment
35

About the trial

Sponsor
Prevail Therapeutics (with Eli Lilly and Company)
Tested
LY3884963 (biological), Methylprednisolone (drug), Optional Sirolimus (drug), Optional Prednisone (drug)
Dates
Started 2020-11-09; completion 2029-11-30
Results posted
Not yet

Study J4B-MC-OKAA is a Phase 1/2, multi-center, open-label ascending dose, first-in-human study that will evaluate the safety and effect of intra-cisternal LY3884963 administration on progranulin protein (PGRN) levels in patients with frontotemporal dementia with progranulin mutations (FTD-GRN). Two escalating dose (low dose and medium dose) cohorts are planned, as well as one bridging cohort which will allocate patients to receive either low or medium dose. The duration of the study is 5 years. During the first year, patients will be evaluated for the effect of LY3884963 on safety, tolerability, immunogenicity, biomarkers, and efficacy. Patients will follow up for an additional 4 years t…

From ClinicalTrials.gov, last updated 2026-07-16. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Eli Lilly and Company reported $303,696 in research payments for this study in 2025 (3 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.