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Monoclonal Antibodies

LY3884961 for Gaucher Disease

Phase 1 & 2
Recruiting
Research Sponsored by Prevail Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
The study tests different doses of LY3884961 in adults with GD's peripheral symptoms. It's an open-label trial where everyone knows they're getting the drug, lasting about 5 years with close monitoring for safety, immune response, biomarkers, and effectiveness.
What are the potential side effects?
Since it's a dose-finding study for LY3884961, potential side effects are being evaluated; however typical concerns may include reactions at the injection site, liver issues due to medication metabolism or immune system responses affecting various organs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and severity of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Secondary study objectives
Discontinuation of enzyme replacement therapy (ERT)/substrate reduction therapy (SRT)
GCase levels
GluSph levels
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: LY3884961Experimental Treatment1 Intervention
LY3884961 is an advanced therapy investigational medicinal product administered as a single intravenous infusion.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Gaucher Disease include enzyme replacement therapy (ERT) and substrate reduction therapy (SRT). ERT works by supplementing the deficient enzyme, glucocerebrosidase, which helps break down the fatty substance glucocerebroside that accumulates in cells. This reduces the burden of the disease and alleviates symptoms. SRT, on the other hand, decreases the production of glucocerebroside, thereby reducing its accumulation. The investigational treatment LY3884961 is being studied for its potential to address peripheral manifestations of Gaucher Disease, likely by targeting similar pathways to improve enzyme function or reduce substrate accumulation. Understanding these mechanisms is crucial for Gaucher Disease patients as it directly impacts the effectiveness of the treatment in managing symptoms and improving quality of life.

Find a Location

Who is running the clinical trial?

Prevail TherapeuticsLead Sponsor
4 Previous Clinical Trials
173 Total Patients Enrolled
1 Trials studying Gaucher Disease
15 Patients Enrolled for Gaucher Disease
Eli Lilly and CompanyIndustry Sponsor
2,680 Previous Clinical Trials
3,466,369 Total Patients Enrolled
1 Trials studying Gaucher Disease
15 Patients Enrolled for Gaucher Disease
Sarah Neuhaus, DOStudy DirectorPrevail Therapeutics, a wholly owned subsidiary of Eli Lilly and Company

Media Library

Gaucher Disease Clinical Trial 2023: LY3884961 Highlights & Side Effects. Trial Name: NCT05487599 — Phase 1 & 2
LY3884961 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05487599 — Phase 1 & 2
~10 spots leftby Oct 2030
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