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LY3962681 (SAD) for Parkinson's Disease

Phase 1
Waitlist Available
Research Sponsored by Prevail Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Participant is overtly healthy as determined by medical evaluation. Rescreening is allowed in this study.
* A Montreal Cognitive Assessment score greater than 26.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 76 weeks
Awards & highlights

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 (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 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.

Who is the study for?
This trial is for healthy volunteers and people with Parkinson's Disease. Participants will receive either the experimental drug LY3962681 or a placebo directly into their spinal fluid. The study has two parts: one where healthy individuals get a single dose, and another where Parkinson's patients get two doses.
What is being tested?
The trial tests the safety and effects of LY3962681 on the body (PK/PD) when given in increasing amounts. Healthy participants are in the Single Ascending Dose part, while those with Parkinson's are in Multiple Ascending Doses part, receiving treatments weeks apart.
What are the potential side effects?
Possible side effects aren't specified but may include typical reactions to spinal injections like headache, back pain, nausea or infection risk at injection site. Other side effects could relate to how LY3962681 affects Parkinson’s symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 76 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 76 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Serious Adverse Events (SAEs)
Incidence of Treatment Emergent Adverse Events (TEAEs)
Number of discontinuations due to Adverse Events (AEs)
Secondary study objectives
Change from baseline in CSF total alpha-synuclein
LY3962681 Maximum Observed Concentration (Cmax)
LY3962681 area under the concentration versus time curve

Trial Design

2Treatment groups
Experimental Treatment
Group I: LY3962681 (SAD)Experimental Treatment2 Interventions
Single ascending dose of LY3962681 or placebo administered intrathecally (IT) to healthy volunteers.
Group II: LY3962681 (MAD)Experimental Treatment2 Interventions
Multiple ascending doses of LY3962681 or placebo administered IT to participants with Parkinson's disease.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Prevail TherapeuticsLead Sponsor
4 Previous Clinical Trials
73 Total Patients Enrolled
Travis LewisStudy DirectorPrevail Therapeutics, a Wholly Owned Subsidiary of Eli Lilly and Company
~72 spots leftby May 2029
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