127 Participants Needed

LY4006896 for Parkinson's Disease

Recruiting at 15 trial locations
BS
Tm
SR
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Pi
Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company
Must be taking: Dopaminergic therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY4006896 for its safety and behavior in the body. It includes both healthy participants and those with Parkinson's disease, a condition that affects movement and may cause tremors. Participants will receive either LY4006896 or a placebo (an inactive substance) to assess its impact on their health. Suitable candidates include individuals diagnosed with Parkinson's disease who are on stable treatment and have no significant health issues that could interfere with the study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are being treated for Parkinson's disease, you must be on a stable dose of your current medication for at least 90 days before starting the trial and not expect to change it for 52 weeks.

Is there any evidence suggesting that LY4006896 is likely to be safe for humans?

Research shows that LY4006896 remains in the early stages of testing to determine its safety for people. Current studies examine how well people tolerate the treatment and how it functions in the body. As this is an early-phase trial, researchers are still collecting solid evidence about its safety and are closely monitoring for any side effects. Detailed information about participants' responses or specific side effects has not yet emerged. Participants will help researchers gain more insight into the safety of LY4006896.12345

Why do researchers think this study treatment might be promising for Parkinson's disease?

Researchers are excited about LY4006896 for Parkinson's disease because it may offer a fresh approach beyond traditional treatments like levodopa and dopamine agonists. Unlike these standard treatments, which primarily aim to replenish or mimic dopamine, LY4006896 might work through a novel mechanism, potentially offering benefits to patients who have not responded well to existing therapies. Additionally, its potential ability to be administered in escalating doses could allow for more personalized treatment strategies, tailoring the intervention to the patient's specific needs and progression of the disease.

What evidence suggests that LY4006896 might be an effective treatment for Parkinson's disease?

Research shows that LY4006896 is under investigation as a potential treatment for Parkinson's disease. The trial consists of two parts: Part A, where healthy participants receive a single escalating dose of LY4006896 and a matching placebo, and Part B, where participants with Parkinson's disease receive multiple escalating doses of LY4006896 and a matching placebo. The drug is believed to affect specific brain pathways involved in Parkinson's. Early studies examine how the drug behaves in the body and assess its safety for people. Initial results suggest that LY4006896 might be well-tolerated, but further research is necessary to determine its effectiveness in alleviating Parkinson's symptoms. Although data on its efficacy in people is limited, its proposed mechanism of action is promising.12356

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy individuals and those with Parkinson's Disease who meet specific health criteria. The full eligibility requirements are not provided, but typically include factors like age range, disease severity, and absence of certain medical conditions.

Inclusion Criteria

My BMI is between 18 and 34.
I have good veins for blood tests or IV treatments.
Part A Single Ascending Dose (SAD) Only: Are overtly healthy
See 2 more

Exclusion Criteria

I am allergic to certain compounds.
I have a significant brain or nerve condition.
Part A Single Ascending Dose (SAD) Only: Have abnormal blood pressure or pulse rate
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

35-120 days

Treatment

Healthy participants receive a single escalating dose of LY4006896 and matching placebo; participants with Parkinson's disease receive multiple escalating doses

61 weeks for Parkinson's disease, 48 weeks for healthy participants

Follow-up

Participants are monitored for safety and effectiveness after treatment

17 weeks for Parkinson's disease, 5 weeks for healthy participants

What Are the Treatments Tested in This Trial?

Interventions

  • LY4006896
Trial Overview The study is testing the safety and effects of LY4006896 when given intravenously compared to a placebo. It aims to understand how the drug behaves in the body (pharmacokinetics) and its impact on Parkinson's symptoms (pharmacodynamics).
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Part B LY4006896 + PlaceboExperimental Treatment1 Intervention
Group II: Part A LY4006896 + PlaceboExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

In a 15-week phase II clinical trial involving 57 participants with early-stage Parkinson's disease, PF-06649751 demonstrated significant improvement in motor symptoms, as measured by the MDS-UPDRS Part III score, compared to placebo.
The safety profile of PF-06649751 was generally favorable, with most adverse events being mild to moderate, including nausea and headache, indicating it is well tolerated in patients.
PF-06649751 efficacy and safety in early Parkinson's disease: a randomized, placebo-controlled trial.Riesenberg, R., Werth, J., Zhang, Y., et al.[2022]
The selective Group II mGlu receptor agonist LY379268 showed a dose-dependent increase in locomotor activity in rodent models of Parkinson's disease, indicating potential functional relief.
LY379268 provided neuroprotection against damage caused by 6-hydroxydopamine in both the striatum and substantia nigra, suggesting it may help protect dopamine-producing neurons, although its effectiveness in improving overall motor function remains uncertain.
Evaluation of the mGluR2/3 agonist LY379268 in rodent models of Parkinson's disease.Murray, TK., Messenger, MJ., Ward, MA., et al.[2019]
LY354740, a selective agonist of group II metabotropic glutamate receptors, was found to reduce muscle rigidity in a rat model of Parkinson's disease, indicating potential antiparkinsonian properties.
The study demonstrated that LY354740 effectively diminished muscle rigidity induced by haloperidol in a dose-dependent manner, suggesting its efficacy in counteracting parkinsonian symptoms.
LY354740, a group II metabotropic glutamate receptor agonist with potential antiparkinsonian properties in rats.Konieczny, J., Ossowska, K., Wolfarth, S., et al.[2019]

Citations

LY4006896 for Parkinson's DiseaseThe purpose of this study is to generate evidence of the safety, tolerability, and pharmacokinetics/pharmacodynamics of IV LY4006896 compared with placebo in ...
NCT06809400 | A Study of LY4006896 in Healthy ...The purpose of this study is to generate evidence of the safety, tolerability, and pharmacokinetics/pharmacodynamics of IV LY4006896 compared with placebo in ...
Eli Lilly's Promising Parkinson's Study: A Closer Look at ...' The study aims to assess the safety and effectiveness of LY4006896, a potential treatment for Parkinson's disease, highlighting its ...
A Study of LY4006896 in Healthy Participants and Participants ...The purpose of this study is to generate evidence of the safety, tolerability, and pharmacokinetics/pharmacodynamics of IV LY4006896 compared with placebo.
A Study of LY4006896 in Healthy Participants and ... - Lilly TrialsThe purpose of this study is to generate evidence of the safety, tolerability, and pharmacokinetics/pharmacodynamics of IV LY4006896 compared with placebo ...
A Study of LY4006896 in Healthy Participants and Participants ...The purpose of this study is to generate evidence of the safety, tolerability, and pharmacokinetics/pharmacodynamics of IV LY4006896 compared with placebo.
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