Enrolling
A Clinical Trial of PR001 (LY3884961) in Patients With Peripheral Manifestations of Gaucher Disease (PROCEED)
The main purpose of this study is to evaluate the safety and tolerability of LY3884961 (PR001) in adult participants with Type 1 Gaucher Disease.
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Trial Summary
Age Range
18 - 65 yearsConditions the trial is for
Gaucher Disease, Type 1What the trial is testing?
LY3884961Could I receive a Placebo?
NoEnrollment Goal
15Trial Dates
Dec 20, 2022 - Oct 2030How long will I be in the trial?
5 years (1.5 years for the main study period and 3.5 years for the follow-up period)Trial Phase
IIKey Requirements
Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.Participants Must:
Be 18 to 65 years old
Have bi-allelic GBA1 gene mutations. If you do not know your genetic status, centralized testing will be performed
On Enzyme Replacement Therapy or Substrate Reduction Therapy
Participants Must Not:
Have had complete spleen removal
Have a history of significant liver disease
Have serious illnesses that could interfere with this study (will be assessed by the investigator)
Have taken certain medicines or had certain treatments, such as any type of prior gene or cell therapy
Become pregnant or impregnate others during the study
Have problems undergoing an MRI
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Clinical Trial Resources
You will complete the questionnaire on another website.YesNo