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New treatment option for Parkinson's Disease
Official title A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease
ClinicalTrials.gov ID: NCT06565195
What this study is testing
What is LY3962681?
LY3962681 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for parkinson's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- MAD study only: Significant neurological disease affecting the central nervous system other than Parkinson's disease that may be a cause for the...
- Current concomitant disease or serious or unstable illnesses, including central nervous system (SAD study only), cardiovascular, hepatic, renal...
- Participant is generally frail or has any medical disorders that, in the opinion of the investigator, could interfere with study-related procedures...
- Have a 12-lead ECG abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study...
- 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...
See the full eligibility 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.
- 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...
- 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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Austin, Texas, United States
- Tōon, Ehime, Japan
- Yufu, Oita Prefecture, Japan
- Hachiōji, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Austin, Texas, United States; Tōon, Ehime, Japan; Yufu, Oita Prefecture, Japan; Hachiōji, Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.