LY3884961 for Gaucher Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug called LY3884961 in adults with specific symptoms of Gaucher Disease. The study aims to find the safest and most effective dose by observing how patients' bodies react to different amounts of the drug. Researchers will monitor safety, side effects, and changes in disease symptoms over several years.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must have been on enzyme replacement therapy (ERT) or substrate reduction therapy (SRT) for at least 2 years and on a stable dose for at least 3 months before joining. You cannot use GD-related chaperone therapy within 4 weeks before starting the trial.
How does the drug LY3884961 differ from other treatments for Gaucher Disease?
Who Is on the Research Team?
Sarah Neuhaus, DO
Principal Investigator
Prevail Therapeutics, a wholly owned subsidiary of Eli Lilly and Company
Are You a Good Fit for This Trial?
Adults aged 18-65 with Gaucher Disease (GD) and specific GBA1 mutations can join this trial. They must have been on enzyme replacement therapy (ERT) or substrate reduction therapy (SRT) for at least 2 years, but not responding well enough. Participants need to use effective birth control and cannot donate blood for a year.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous dose of LY3884961 and are evaluated for safety, tolerability, immunogenicity, biomarkers, and efficacy
Follow-up
Participants are monitored for safety, immunogenicity, and selected biomarker and efficacy parameters
What Are the Treatments Tested in This Trial?
Interventions
- LY3884961
- Methylprednisolone
- Prednisone
- Sirolimus
LY3884961 is already approved in United States, European Union for the following indications:
- Type 1 Gaucher Disease (GD1)
- Type 2 Gaucher Disease (GD2)
- Parkinson's disease with GBA1 mutations (PD-GBA)
- Type 1 Gaucher Disease (GD1)
- Type 2 Gaucher Disease (GD2)
- Parkinson's disease with GBA1 mutations (PD-GBA)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Prevail Therapeutics
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University