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A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease
NCT06565195 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and PK/PD of LY3962681 in healthy volunteers and patients with Parkinson's disease. The study will be comprised of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Doses (MAD) study. During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (artificial cerebrospinal fluid (aCSF), no active drug) given into the spinal fluid. During the MAD portion of the study, patients with Parkinson's disease will receive two doses of either LY3962681 or placebo (aCSF) administered into the spinal fluid. * The treatment period in the SAD study will be 1 day. The treatment period in the MAD study will be 2 days, 12 to 24 weeks apart. * The follow-up period in the SAD study will be up to 52 weeks. The follow-up period in the MAD study will be up to 52 weeks post Dose 2.
Conditions Studied
Interventions
- DRUG LY3962681
- OTHER Placebo (aCSF)
Study Locations (4)
Texas
- Austin Clinic PPD — Austin
Ehime
- Ehime University Hospital — Tōon
Oita Prefecture
- Oita University Hospital — Yufu
Tokyo
- P-One Clinic, Keikokai Medical Corporation — Hachiōji
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2024-08-27 |
| Est. Completion | 2029-05-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06565195
The ClinicalTrials.gov registry entry for NCT06565195 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prevail Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions — of which LY3962681 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06565195 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Texas, Ehime, Oita Prefecture. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06565195 about?
NCT06565195 is a clinical study titled "A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease". The purpose of this study is to evaluate the safety, tolerability, and PK/PD of LY3962681 in healthy volunteers and patients with Parkinson's disease. The study will be comprised of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Doses (MAD) study. During the SAD portion...
What is the current status of trial NCT06565195?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 2024-08-27. Estimated completion is 2029-05-05.
What conditions does trial NCT06565195 study?
This clinical trial studies the following conditions: Parkinson's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06565195?
The interventions under investigation include: LY3962681 (DRUG), Placebo (aCSF) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06565195?
This trial is sponsored by Prevail Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06565195 being conducted?
This trial has 4 study locations across Texas, Ehime, Oita Prefecture, Tokyo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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