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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 52 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of LY3962681, how the body handles it, and its effects in healthy volunteers and people with Parkinson's disease. Healthy volunteers get one dose, and people with Parkinson's get two doses, 12 to 24 weeks apart. Each dose is either LY3962681 or a placebo (fluid with no study drug), given into the spinal fluid.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be judged healthy by a medical exam and score at least 24 on a memory and thinking test.
  • For the two-dose part: Have Parkinson's disease that meets the study's rules, with a stage of 1 to 2.5 when medicine effects are low.
  • For the two-dose part: Have stable medicines and Parkinson's treatments for at least 8 weeks, with no dose changes expected for at least 6 months.
  • For the two-dose part: If not taking Parkinson's medicines, not be expected to start them within 6 months.
  • For the two-dose part in the US and Japan: Have a positive spinal fluid test for a protein called alpha-synuclein.
  • For the two-dose part in the EU and UK: Score in the lowest 20% on a smell test, based on age and sex.
  • For the two-dose part: Have an abnormal DaT-SPECT brain scan that fits with Parkinson-like disease.
  • For the two-dose part: Weigh 88 to 242 pounds and have a body mass index (BMI), a measure based on height and weight, of 17 to 34.

Who can't join

  • For the two-dose part: Have another major brain or nerve disease that could explain symptoms or affect study results.
  • Have an illness that the study doctor thinks could make the study unsafe or affect the results.
  • Be frail or have a condition that makes study procedures unsafe, such as serious spine problems, bleeding problems, or high pressure around the brain.
  • Have an abnormal ECG (heart rhythm test) that could raise risks or affect study results.
  • For the two-dose part: Get Parkinson's medicine continuously through a tube into the gut, such as Duodopa.
  • For the two-dose part: Have poor kidney function, with an eGFR kidney test result below 45.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (7)

CO

CT

FL

IL

MI

PA

TX