Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3884961 · 3 trials · 4 indications
Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) with AE's graded as mild, moderate, or severe.
GCase (glucocerebrosidase)
GCase (glucocerebrosidase)
GCase (glucocerebrosidase)
GCase (glucocerebrosidase)
| Arm | Type | Description |
|---|---|---|
| LY3884961 | EXPERIMENTAL | LY3884961 is an advanced therapy investigational medicinal product administered as a single intravenous infusion. |
| Low Dose | EXPERIMENTAL | - |
| High Dose | EXPERIMENTAL | - |
| Dose Level 1 | EXPERIMENTAL | - |
| Dose Level 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| LY3884961 | GENETIC | • LY3884961 is a replication-incompetent recombinant adeno-associated virus (AAV) vector. The vector is composed of a ss DNA genome packaged in an AAV-derived protein capsid. |
| Methylprednisolone | DRUG | Single IV pulse administered as concomitant medication. |
| Sirolimus | DRUG | Loading dose, followed by maintenance doses, followed by dose tapering; administered as concomitant medication. |
| Prednisone | DRUG | Administered orally as concomitant medication, followed by dose tapering. |
Inclusion Criteria: 1. Age greater or equal to 18 years at the time of informed consent. 2. Bi-allelic pathogenic GBA1 variants must be centrally confirmed. 3. On ERT or SRT for at least 2 years and on a stable, maximum tolerated dose, for at least 3 months prior to screening. 4. Capable of giving ...
LY3884961 is an investigational gene therapy being developed by Eli Lilly and Company for Gaucher disease and Parkinson disease. It is designed to deliver a functional copy of the GBA1 gene to address the underlying genetic cause of these conditions. It is currently in Phase 1 clinical development.
LY3884961 is being studied for the treatment of Gaucher disease, including type 2 Gaucher disease, and Parkinson disease. Clinical trials are evaluating it in patients with peripheral manifestations of Gaucher disease, infants with type 2 Gaucher disease, and Parkinson disease patients with at least one GBA1 mutation.
LY3884961 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker symbol LLY. Lilly is conducting clinical trials of the gene therapy in the United States, Australia, Germany, Spain, the United Kingdom, and Israel.
LY3884961 is in Phase 1 clinical development. It has not been approved by the FDA and remains an investigational therapy. The Phase 1 trials are currently active but not recruiting participants.
LY3884961 is being evaluated in three clinical trials: NCT05487599 (PROCEED) in patients with peripheral manifestations of Gaucher disease, NCT04411654 (PROVIDE) in infants with type 2 Gaucher disease, and NCT04127578 (PROPEL) in Parkinson disease patients with at least one GBA1 mutation. All are active but not recruiting.