Actively Recruiting
A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease
Led by Prevail Therapeutics · Updated on 2026-01-14
108
Participants Needed
4
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is overtly healthy as determined by medical evaluation
- Montreal Cognitive Assessment score greater than or equal to 24
- Stable use of background medications at least 8 weeks prior to investigational product administration and expected tolerance for minimum 6 months without dose adjustment
- Parkinson's disease diagnosis per UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (MAD study only)
- Modified Hoehn and Yahr Stage 1 to 2.5 in OFF state (MAD study only)
- Positive CSF alpha-synuclein Seed Amplification Assay result (within 1 year of screening) or prior positive with sponsor approval (MAD study only, US and Japan only)
- UPSIT score at 10th percentile or less, corrected for age and sex (MAD study only, EU and UK only)
- Abnormal DaT-SPECT consistent with parkinsonism (MAD study only)
- Not expected to start Parkinson's disease medication within 6 months if not currently taking (MAD study only)
- Body weight between 40 kg (88 pounds) and 110 kg (242 pounds), and BMI between 17 and 34 kg/m² (MAD study only)
You will not qualify if you...
- Significant neurological disease affecting CNS other than Parkinson's disease (MAD study only)
- Current serious or unstable illnesses affecting CNS (SAD study only), cardiovascular, hepatic, renal, gastroenterology, respiratory, endocrinologic, neurologic (MAD study only except Parkinson's), psychiatric, immunologic, or hematologic systems
- Frailty or medical disorders interfering with study procedures including IT injection or lumbar puncture
- Prohibitive spinal diseases, bleeding diathesis, coagulopathy, thrombocytopenia, or increased intracranial pressure
- 12-lead ECG abnormalities increasing study risks or confounding data
- Treatment with continuous intestinal delivery Parkinson's disease medication (MAD study only)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Austin Clinic PPD
Austin, Texas, United States, 78744-1625
Actively Recruiting
2
Ehime University Hospital
Tōon, Ehime, Japan, 791-0295
Not Yet Recruiting
3
Oita University Hospital
Yufu, Oita Prefecture, Japan, 879-5593
Not Yet Recruiting
4
P-One Clinic, Keikokai Medical Corporation
Hachiōji, Tokyo, Japan, 192-0071
Actively Recruiting
Research Team
P
Prevail Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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