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LY3962681 for Parkinson's Disease (PROSPECT Trial)

Phase 1
Recruiting
Research Sponsored by Prevail Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable use of background medications at least 8 weeks prior to IP administration, including but not limited to those used for treatment of Parkinson's disease (including deep brain stimulation), and the investigator must expect that participant can tolerate a minimum of 6 months without dose adjustment
Participant has a diagnosis of Parkinson's disease per UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial will test a drug called LY3962681 in both healthy volunteers and patients with Parkinson's disease. The study has two parts - Single Ascending Dose (SAD) and Multiple Asc

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
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My medications for Parkinson's or other conditions have been stable for 8 weeks.
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I have been diagnosed with Parkinson's disease.
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My Parkinson's is in the early to mid-stage without medication.
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My weight is between 88 and 242 pounds, and my BMI is between 17 and 34.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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
80 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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