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A Clinical Trial of PR001 (LY3884961) in Patients With Peripheral Manifestations of Gaucher Disease (PROCEED)

Active, not recruiting · Phase 1, Phase 2 · NCT05487599

Conditions: Gaucher Disease, Gaucher Disease, Type 1

At a glance

Research payments reported, 2025
$115,164
U.S. investigators named
3
Sites paid
3
Planned or actual enrollment
8

About the trial

Sponsor
Prevail Therapeutics (with Eli Lilly and Company)
Tested
LY3884961 (genetic)
Dates
Started 2022-12-20; completion 2031-08-30
Results posted
Not yet

Study J3Z-MC-OJAE is a Phase 1/2, multicenter, open-label, dose-finding study of LY3884961 evaluating the safety and tolerability in adults with peripheral manifestations of GD. Up to 3 dose levels of LY3884961 will be assessed in 3 dose-finding cohorts of 3 patients. Following this, up to 6 patients may be enrolled in an expansion cohort. For each enrolled patient, the study will be approximately 5 years in duration, including up to a 60-day screening period. During the first 18 months after dosing, subjects will be evaluated for the effects of LY3884961 on safety, tolerability, immunogenicity, biomarkers, and efficacy. Patients will be followed for an additional 42 months to monitor saf…

From ClinicalTrials.gov, last updated 2026-08-17. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Eli Lilly and Company reported $115,164 in research payments for this study in 2025 (5 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.