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Recruiting Phase 1 Interventional Accepts healthy volunteers

A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease

ClinicalTrials.gov ID: NCT06565195

Public ClinicalTrials.gov record NCT06565195. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 25, 2026, 5:01 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind (Sponsor-unblinded), Placebo-controlled, Single-ascending-dose Study in Healthy Volunteers and a Double-blind (Sponsor-unblinded), Placebo-controlled, Multiple-ascending-dose Study in Patients With Parkinson's Disease to Evaluate the Safety, Tolerability, and PK/PD of LY3962681

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of LY3962681 in healthy volunteers and patients with Parkinson's disease. The study consists of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Dose (MAD) study. During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (artificial cerebrospinal fluid \[aCSF\]) administered intrathecally (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 intrathecally (into the spinal fluid), 12 to 24 weeks apart. * The treatment period in the SAD study will be 1 day. The treatment period in the MAD study will be 2 dosing 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 after Dose 2.

Study identification

NCT ID
NCT06565195
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Prevail Therapeutics
Industry
Enrollment
124 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
30 Years to 80 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 26, 2024
Primary completion
Jul 22, 2030
Completion
Jul 22, 2030
Last update posted
Aug 31, 2026

2024 – 2030

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
CenExel Englewood Colorado 80113 Not yet recruiting
XingImaging LLC New Haven Connecticut 06510 Not yet recruiting
Aqualane Clinical Research Naples Florida 34105 Recruiting
Northwestern University Feinberg School of Medicine Dept of Neurology Chicago Illinois 60611 Not yet recruiting
Quest Research Institute - Alcanza Farmington Hills Michigan 48334 Not yet recruiting
University of Pennsylvania, Dept of Neurology Philadelphia Pennsylvania 19107 Not yet recruiting
Austin Clinic PPD Austin Texas 78744-1625 Completed

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06565195, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 31, 2026 · Synced Sep 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06565195 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →