Condition: Gaucher Disease · Gaucher Disease, Type 1 · Sponsor: Prevail Therapeutics
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 safety, immunogenicity, and selected biomarker and efficacy parameters.
This description comes directly from the study's public registry record.
Prevail Therapeutics · (917) 336-9310 · Prevail.Patients@lilly.com
Always discuss trial participation with your own doctor first.
| Cedars-Sinai | Los Angeles, California, United States | Recruiting |
| Ann and Robert H Lurie Children's Hospital of Chicago | Chicago, Illinois, United States | Recruiting |
| Duke University Health System | Durham, North Carolina, United States | Recruiting |
| Lysosomal & Rare Disorders Research and Treatment Center | Fairfax, Virginia, United States | Recruiting |
| Westmead Hospital-Cnr Hawkesbury and Darcy Rds | Westmead, New South Wales, Australia | Completed |
| Hospital de Clinicas de Porto Alegre (HCPA) | Porto Alegre, Rio Grande do Sul, Brazil | Recruiting |
| SphinCS Clinical Science for LSD | Höchheim, Germany | Recruiting |
| Hospital Quironsalud Zaragoza, Paseo Mariano Renovales Sn | Zaragoza, Spain | Recruiting |
| Royal Free Hospital NHS Trust | London, United Kingdom | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05487599