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A Study of LY3962681 for Parkinson's Disease

This study is testing a drug called LY3962681 in healthy volunteers and people with Parkinson's disease. The main goal is to see how safe LY3962681 is, how well your body tolerates it, and how it moves through your system. Some participants will receive LY3962681, while others will receive a placebo (aCSF), which is like a dummy treatment. The drug or placebo will be given as an intrathecal (into the spinal fluid) injection. The study is looking for people aged 30 to 80 years old who are generally healthy and have a good score on a cognitive test. The study aims to enroll 124 participants, but its current recruitment status is unclear.

Study design
This interventional study has two parts: a Single Ascending Dose (SAD) study for healthy volunteers and a Multiple Ascending Dose (MAD) study for patients with Parkinson's disease. Participants will receive either LY3962681 or a placebo.
What's involved
Healthy volunteers in the SAD study will receive a single intrathecal injection over one day. Patients with Parkinson's disease in the MAD study will receive two intrathecal injections, 12 to 24 weeks apart.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety, including serious adverse events and treatment-emergent adverse events, for up to 76 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06565195

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

Recruiting
PHASE1Ages 30–80InterventionalTreatment
Prevail Therapeutics
~124 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:LY3962681Placebo (aCSF)

At a glance

Recruiting sites
3 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Serious Adverse Events (SAEs)
Measured over Up to 76 weeks
+2 more outcomes measured

Conditions

Parkinson's Disease

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NCT06565195

Where you'd take part

This study runs at 16 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Aqualane Clinical Research

    Naples, Floridastudy coordinator listed

    Recruiting

  • CTC Netherlands BV

    Groningen, Provincie Groningen, Netherlandsstudy coordinator listed

    Not yet recruiting

  • Ehime University Hospital

    Tōon, Ehime, Japanstudy coordinator listed

    Recruiting

  • Oita University Hospital

    Yufu, Oita Prefecture, Japanstudy coordinator listed

    Not yet recruiting

  • P-One Clinic, Keikokai Medical Corporation

    Hachiōji, Tokyo, Japanstudy coordinator listed

    Recruiting

  • CenExel

    Englewood, Coloradono site contact published

    Not yet recruiting

  • John Radcliffe Hospital

    Oxford, Oxfordshire, United Kingdomno site contact published

    Not yet recruiting

  • Northwestern University Feinberg School of Medicine Dept of Neurology

    Chicago, Illinoisno site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Prevail Therapeutics
[email protected]
917-336-9310
Email the study team

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Eligibility criteria

Inclusion

Participant is overtly healthy as determined by medical evaluation. Rescreening is allowed in this study.
A Montreal Cognitive Assessment score greater than or equal to 24.
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.
Modified Hoehn and Yahr Stage 1 to 2.5 in the practically defined OFF state.
A positive result on CSF alpha-synuclein Seed Amplification Assay. (A prior positive result \[within 1 year of screening\] accepted with sponsor approval if patient did not participate in another Parkinson's disease clinical trial during this period.) (US and Japan only)
UPSIT score of 20 percentile or less, corrected for age and sex (EU and UK only).
An abnormal DaT-SPECT consistent with parkinsonism. (History of an abnormal DaTSPECT with the report confirmed by study investigator will be accepted.)
For participants not taking Parkinson's disease medications, not expected to initiate treatment within 6 months.
Have a body weight within 40 kg (88 pounds) to 110 kg (242 pounds), inclusive, and body mass index within the range of 17 to 34 kg/m\^2, inclusive.

Exclusion

MAD study only: Significant neurological disease affecting the central nervous system other than Parkinson's disease that may be a cause for the participant's clinical symptoms or may confound study objectives.
Current concomitant disease or serious or unstable illnesses, including central nervous system (SAD study only), cardiovascular, hepatic, renal, gastroenterology, respiratory, endocrinologic, neurologic (MAD study only: other than Parkinson's disease), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable safety risk to the participant.
Participant is generally frail or has any medical disorders that, in the opinion of the investigator, could interfere with study-related procedures (including safe performance of IT injection or LP), such as prohibitive spinal diseases, bleeding diathesis, clinically significant coagulopathy, thrombocytopenia, or increased intracranial pressure.
Have a 12-lead ECG abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.
MAD study only: Treatment with continuous intestinal delivery Parkinson's disease medication (for example, Duodopa).
MAD study only: Significant renal impairment (estimated glomerular filtration rate \[eGFR\] \<45 mL/min/1.73 m\^2).

What this trial measures

  • Incidence of Serious Adverse Events (SAEs)Up to 76 weeks
  • Incidence of Treatment Emergent Adverse Events (TEAEs)Up to 76 weeks
  • Number of discontinuations due to Adverse Events (AEs)Up to 76 weeks