New Parkinson's drug enters early human testing
NCT ID NCT06565195
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times
Summary
This early-stage study tests a new drug called LY3962681 in healthy volunteers and people with Parkinson's disease. The goal is to check if the drug is safe and how the body processes it. Participants receive either the drug or a placebo injected into the spinal fluid, and are followed for up to a year.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 124 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. MAD study only * 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 Criteria: * 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). Other protocol-defined inclusion/exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
15 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aqualane Clinical Research
RECRUITINGNaples, Florida, 34105, United States
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Austin Clinic PPD
COMPLETEDAustin, Texas, 78744-1625, United States
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CTC Netherlands BV
NOT_YET_RECRUITINGGroningen, Provincie Groningen, 9713 GZ, Netherlands
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CenExel
NOT_YET_RECRUITINGEnglewood, Colorado, 80113, United States
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Ehime University Hospital
RECRUITINGTōon, Ehime, 791-0295, Japan
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John Radcliffe Hospital
NOT_YET_RECRUITINGOxford, Oxfordshire, OX3 9DU, United Kingdom
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Northwestern University Feinberg School of Medicine Dept of Neurology
NOT_YET_RECRUITINGChicago, Illinois, 60611, United States
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Oita University Hospital
NOT_YET_RECRUITINGYufu, Oita Prefecture, 879-5593, Japan
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P-One Clinic, Keikokai Medical Corporation
RECRUITINGHachiōji, Tokyo, 192-0071, Japan
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Quest Research Institute - Alcanza
NOT_YET_RECRUITINGFarmington Hills, Michigan, 48334, United States
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Radboud Universitair Medisch Centrum
NOT_YET_RECRUITINGNijmegen, Gelderland, 6525 GA, Netherlands
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Southampton General Hospital, NHS Trust
NOT_YET_RECRUITINGSouthampton, Hampshire, SO16 6TH, United Kingdom
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University of Pennsylvania, Dept of Neurology
NOT_YET_RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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Universitätsklinikum Düsseldorf
NOT_YET_RECRUITINGDüsseldorf, North Rhine-Westphalia, 40225, Germany
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Universitätsklinikum Münster
NOT_YET_RECRUITINGMünster, North Rhine-Westphalia, 48149, Germany
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XingImaging LLC
NOT_YET_RECRUITINGNew Haven, Connecticut, 06510, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Walking memory tests may reveal early Parkinson's clues
- Colon tissue may hold clues to telling Parkinson's apart from Look-Alike diseases
- A genetic roadmap for Parkinson's: testing thousands to unlock clues
- Can gentle touch therapy calm Parkinson's tremors?
- Stem cell infusions aim to slow Parkinson's progression
- Can an inhaled levodopa ease Parkinson's OFF episodes? a study asks patients.