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

NCT06565195 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-05-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

LY3962681

IT injection

OTHER

Placebo (aCSF)

IT injection

Sponsors & Collaborators

  • Prevail Therapeutics

    lead INDUSTRY

Principal Investigators

  • Travis Lewis · Prevail Therapeutics, a Wholly Owned Subsidiary of Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-27
Primary Completion
2029-05-05
Completion
2029-05-05
FDA Drug
Yes

Countries

  • United States
  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06565195 on ClinicalTrials.gov