Parkinson's DiseasePhase 1PROSPECT-PDNCT06565195
A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease
A Phase 1 study testing LY3962681 in people with Parkinson's Disease, run by Prevail Therapeutics at 16 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- LY3962681
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 27 Aug 2024to 23 Jul 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 5 countries
United States7 sites, 6 recruiting
- Completed
Austin Clinic PPD
Austin, Texas, 78744-1625
- Not yet recruiting
Northwestern University Feinberg School of Medicine Dept of Neurology
Chicago, Illinois, 60611
Camryn Butze, (312) 503-6824, camryn.butze@northwestern.edu
- Not yet recruiting
CenExel
Englewood, Colorado, 80113
Anahaga Champakanath, (303) 867-5468, a.champakanath@cenexel.com
- Recruiting
Quest Research Institute - Alcanza
Farmington Hills, Michigan, 48334
Denise Morgott, (248) 957-8940, Denise.Morgott@questri.com
- Recruiting
Aqualane Clinical Research
Naples, Florida, 34105
Christopher Webb, (239) 529-6780, christopher@aqualaneresearch.com
- Not yet recruiting
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
Anna Carberry, (475) 318-8250, clinicrecruitment@indd.org
- Not yet recruiting
University of Pennsylvania, Dept of Neurology
Philadelphia, Pennsylvania, 19107
Spriha Thapa, (267) 610-8822, Spriha.Thapa@PennMedicine.upenn.edu
Japan3 sites, 3 recruiting
- Recruiting
P-One Clinic, Keikokai Medical Corporation
Hachiōji, Tokyo, 192-0071
Yukari Kaneko, 080-8759-9604, kaneko@keikokai-gr.or.jp
- Recruiting
Ehime University Hospital
Tōon, Ehime, 791-0295
Akemi Fujita, 089-960-5913, fujita.akemi.aw@ehime-u.ac.jp
- Not yet recruiting
Oita University Hospital
Yufu, Oita Prefecture, 879-5593
Tomoko Matsuda, 097-586-6114, to-matsu@oita-u.ac.jp
Germany2 sites, 2 recruiting
- Not yet recruiting
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Abraham Nsah Ndifon, +492118108262, abrahamnsah.ndifon@med.uni-duesseldorf.de
- Not yet recruiting
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
Isabel Aymanns, +492518344427, isabel.aymanns@ukmuenster.de
Netherlands2 sites, 2 recruiting
- Not yet recruiting
CTC Netherlands BV
Groningen, Provincie Groningen, 9713 GZ
Khalid Abd-Elaziz, 31503055480, khalid.abdelaziz@ctc-netherlands.com
- Not yet recruiting
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, 6525 GA
Bas Bloem
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
- Not yet recruiting
Southampton General Hospital, NHS Trust
Southampton, Hampshire, SO16 6TH
Danny Pratt, 0044 2381204989, danny.pratt@uhs.nhs.uk
About this study
Official 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
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.
Read more
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
- Parkinson's Disease
- Being tested
- LY3962681, Placebo (aCSF)
- Keywords
- Parkinson's disease, Healthy volunteers
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3962681Drug
IT injection
Placebo (aCSF)Other
IT injection
| Study group | Role | What they receive |
|---|---|---|
| LY3962681 (SAD) | Experimental | Single ascending dose of LY3962681 administered intrathecally (IT) to healthy volunteers. Receives: Drug: LY3962681 |
| Placebo (SAD) | Placebo comparator | Single ascending dose of placebo (aCSF) administered intrathecally (IT) to healthy volunteers. Receives: Other: Placebo (aCSF) |
| LY3962681 (MAD) | Experimental | Multiple ascending doses of LY3962681 administered IT to participants with Parkinson's disease. Receives: Drug: LY3962681 |
| Placebo (MAD) | Placebo comparator | Multiple ascending doses of placebo (aCSF) administered IT to participants with Parkinson's disease. Receives: Other: Placebo (aCSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 76 weeks
Incidence of Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 76 weeks
Number of discontinuations due to Adverse Events (AEs)
Measured: Up to 76 weeks
Secondary outcomes (3)
LY3962681 Maximum Observed Concentration (Cmax)
Measured: Up to 76 weeks
LY3962681 area under the concentration versus time curve (AUC)
Measured: Up to 76 weeks
Change from baseline in CSF total alpha-synuclein
Measured: Up to 76 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start27 Aug 2024
- Primary completion23 Jul 2030 (estimated)
- Study completion23 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prevail Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Travis Lewis, Study director, Prevail Therapeutics, a Wholly Owned Subsidiary of Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565195
- Sponsor's protocol ID
- J5F-MC-OOAA
- Other IDs
- 2024-513411-27-00
- Acronym
- PROSPECT-PD
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06565195
- Acronym / sponsor ID
- PROSPECT-PD / J5F-MC-OOAA
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Prevail TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 23 Jul 2030 (estimated)
- Study completion
- 23 Jul 2030 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3962681 (SAD) | Experimental | Drug: LY3962681Single ascending dose of LY3962681 administered intrathecally (IT) to healthy volunteers. |
| Placebo (SAD) | Placebo comparator | Other: Placebo (aCSF)Single ascending dose of placebo (aCSF) administered intrathecally (IT) to healthy volunteers. |
| LY3962681 (MAD) | Experimental | Drug: LY3962681Multiple ascending doses of LY3962681 administered IT to participants with Parkinson's disease. |
| Placebo (MAD) | Placebo comparator | Other: Placebo (aCSF)Multiple ascending doses of placebo (aCSF) administered IT to participants with Parkinson's disease. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3962681IT injection | Drug | LY3962681 (MAD), LY3962681 (SAD) |
| Placebo (aCSF)IT injection | Other | Placebo (MAD), Placebo (SAD) |
Primary outcome
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 76 weeks
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 76 weeks
Number of discontinuations due to Adverse Events (AEs)
Time frame: Up to 76 weeks
3 secondary outcomes
LY3962681 Maximum Observed Concentration (Cmax)
Time frame: Up to 76 weeks
LY3962681 area under the concentration versus time curve (AUC)
Time frame: Up to 76 weeks
Change from baseline in CSF total alpha-synuclein
Time frame: Up to 76 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Travis Lewis study director
Prevail Therapeutics, a Wholly Owned Subsidiary of Eli Lilly and Company
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3962681 in people with Parkinson's Disease, run by Prevail Therapeutics at 16 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Japan, Germany, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prevail Therapeutics (917-336-9310, Prevail.Patients@lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Serious Adverse Events (SAEs) (time frame: Up to 76 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.