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Early safety testing of a study medicine

Researchers are testing LY3962681 in volunteers with and without Parkinson’s to study safety, unwanted effects and how the body handles the medicine.

Testing a treatment or activity · Study reference: NCT06565195

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

Who can join?

Ages 30 years to 80 years · Also accepts healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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.
Full study name & original research details

Official study title

A Randomized, Double-blind (Sponsor-unblinded), Placebo-controlled, Single-ascending-dose Study in Healthy Volunteers and a Double-blind (Sponsor-unblinded), Placebo-controlled, Multiple-ascending-dose Study in Patients With Parkinson's Disease to Evaluate the Safety, Tolerability, and PK/PD of LY3962681

Short title used by the registry

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

Original description

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of LY3962681 in healthy volunteers and patients with Parkinson's disease. The study consists of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Dose (MAD) study. During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (artificial cerebrospinal fluid \[aCSF\]) administered intrathecally (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 (aCSF) administered intrathecally (into the spinal fluid), 12 to 24 weeks apart. * The treatment period in the SAD study will be 1 day. The treatment period in the MAD study will be 2 dosing 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 after Dose 2.

Conditions reported: Parkinson's Disease

Study type
Interventional
Interventions
LY3962681; Placebo (aCSF)
Phases
PHASE1
Sponsor
Prevail Therapeutics
Start date reported by registry
2024-08-27 (actual)

Registry updated: 2026-10-01 · Status last verified by the registry submitter: 2026-09

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Prevail Therapeutics · 917-336-9310 · Prevail.Patients@lilly.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

CenExel

Englewood, Colorado, United States

Not yet recruiting

Anahaga Champakanath · (303) 867-5468 · a.champakanath@cenexel.com

XingImaging LLC

New Haven, Connecticut, United States

Not yet recruiting

Anna Carberry · (475) 318-8250 · clinicrecruitment@indd.org

Aqualane Clinical Research

Naples, Florida, United States

Recruiting

Christopher Webb · (239) 529-6780 · christopher@aqualaneresearch.com

Northwestern University Feinberg School of Medicine Dept of Neurology

Chicago, Illinois, United States

Not yet recruiting

Camryn Butze · (312) 503-6824 · camryn.butze@northwestern.edu

Quest Research Institute - Alcanza

Farmington Hills, Michigan, United States

Recruiting

Denise Morgott · (248) 957-8940 · Denise.Morgott@questri.com

University of Pennsylvania, Dept of Neurology

Philadelphia, Pennsylvania, United States

Not yet recruiting

Spriha Thapa · (267) 610-8822 · Spriha.Thapa@PennMedicine.upenn.edu

Austin Clinic PPD

Austin, Texas, United States

Completed

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Not yet recruiting

Abraham Nsah Ndifon · +492118108262 · abrahamnsah.ndifon@med.uni-duesseldorf.de

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Not yet recruiting

Isabel Aymanns · +492518344427 · isabel.aymanns@ukmuenster.de

Ehime University Hospital

Tōon, Ehime, Japan

Recruiting

Akemi Fujita · 089-960-5913 · fujita.akemi.aw@ehime-u.ac.jp

Oita University Hospital

Yufu, Oita Prefecture, Japan

Not yet recruiting

Tomoko Matsuda · 097-586-6114 · to-matsu@oita-u.ac.jp

P-One Clinic, Keikokai Medical Corporation

Hachiōji, Tokyo, Japan

Recruiting

Yukari Kaneko · 080-8759-9604 · kaneko@keikokai-gr.or.jp

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, Netherlands

Not yet recruiting

Bas Bloem

CTC Netherlands BV

Groningen, Provincie Groningen, Netherlands

Not yet recruiting

Khalid Abd-Elaziz · 31503055480 · khalid.abdelaziz@ctc-netherlands.com

Southampton General Hospital, NHS Trust

Southampton, Hampshire, United Kingdom

Not yet recruiting

Danny Pratt · 0044 2381204989 · danny.pratt@uhs.nhs.uk

John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom

Not yet recruiting

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.