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New Parkinson's drug enters early human testing

NCT ID NCT06565195

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 124 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

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

30 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    15 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Aqualane Clinical Research

    RECRUITING

    Naples, Florida, 34105, United States

  • Austin Clinic PPD

    COMPLETED

    Austin, Texas, 78744-1625, United States

  • CTC Netherlands BV

    NOT_YET_RECRUITING

    Groningen, Provincie Groningen, 9713 GZ, Netherlands

  • CenExel

    NOT_YET_RECRUITING

    Englewood, Colorado, 80113, United States

  • Ehime University Hospital

    RECRUITING

    Tōon, Ehime, 791-0295, Japan

  • John Radcliffe Hospital

    NOT_YET_RECRUITING

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Northwestern University Feinberg School of Medicine Dept of Neurology

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • Oita University Hospital

    NOT_YET_RECRUITING

    Yufu, Oita Prefecture, 879-5593, Japan

  • P-One Clinic, Keikokai Medical Corporation

    RECRUITING

    Hachiōji, Tokyo, 192-0071, Japan

  • Quest Research Institute - Alcanza

    NOT_YET_RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Radboud Universitair Medisch Centrum

    NOT_YET_RECRUITING

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Southampton General Hospital, NHS Trust

    NOT_YET_RECRUITING

    Southampton, Hampshire, SO16 6TH, United Kingdom

  • University of Pennsylvania, Dept of Neurology

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Universitätsklinikum Düsseldorf

    NOT_YET_RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Universitätsklinikum Münster

    NOT_YET_RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • XingImaging LLC

    NOT_YET_RECRUITING

    New Haven, Connecticut, 06510, United States

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