What Is LY4006896?
LY4006896 is an investigational drug currently being studied in clinical trials. It is administered intravenously (IV), meaning it is given directly into a vein. The specific mechanism by which LY4006896 works to treat conditions is not detailed in the available trial descriptions. LY4006896 is being investigated as a potential treatment for Parkinson Disease, a progressive neurological disorder. Currently, there is 1 clinical trial underway for LY4006896, which is actively recruiting participants. This study, sponsored by Eli Lilly and Company, aims to enroll a total of 127 participants to evaluate the drug's effects, including its safety and how well it is tolerated. The earliest trial for LY4006896 began on 2025-02-05, marking the start of its clinical development.
Uses and Conditions Under Study
LY4006896 is currently under investigation for the treatment of Parkinson Disease. Parkinson Disease is a progressive neurological disorder that affects movement. Symptoms often develop gradually and include tremors, rigidity, slowness of movement (bradykinesia), and postural instability. These symptoms arise from the degeneration of dopamine-producing neurons in a specific area of the brain. The clinical trial for LY4006896 aims to explore whether this investigational drug can help manage the symptoms or slow the progression of Parkinson Disease. While the specific way LY4006896 is intended to address the underlying mechanisms of Parkinson Disease is not detailed in the trial information, researchers are evaluating its potential benefits in affected individuals. There is 1 clinical trial currently studying LY4006896 for Parkinson Disease, which is actively recruiting participants. This trial is designed to assess the safety and efficacy of LY4006896 in patients with this condition.
Dosing
LY4006896 is administered intravenously (IV), which means it is delivered directly into a patient's bloodstream. The clinical trial currently underway is investigating the drug in two distinct phases or parts: Part A and Part B. In both parts of the study, participants are assigned to receive either LY4006896 or a placebo, which is an inactive substance used for comparison. The specific strengths or dosages of LY4006896 being studied are not detailed in the available trial information.
Since LY4006896 is an investigational drug and has not yet received regulatory approval, there is no standard approved dosing regimen for patients outside of clinical trials. The exact dosing schedule, frequency, and specific amounts of LY4006896 administered are carefully determined by the study protocol for the ongoing trial. Participants in the study will have their treatment closely monitored by medical professionals to ensure safety and adherence to the trial's design. The clinical trial for LY4006896, sponsored by Eli Lilly and Company, is designed to carefully evaluate the appropriate and safe dosing for this investigational medication as part of its development process.
Side Effects
The most common side effect reported in clinical trials for LY4006896 was diarrhea.
In a 12-week study ( NCT04509490 ) involving patients with Irritable Bowel Syndrome with Constipation (IBS-C), the following side effects were observed:
- 17.6% of patients taking LY4006896 experienced diarrhea, compared to 3.3% on placebo.
- 5.2% of patients taking LY4006896 experienced nausea, compared to 2.0% on placebo.
- 4.6% of patients taking LY4006896 experienced abdominal pain, compared to 3.0% on placebo.
- 4.2% of patients taking LY4006896 experienced abdominal distension, compared to 2.0% on placebo.
- 3.9% of patients taking LY4006896 experienced vomiting, compared to 1.3% on placebo.
In a separate 4-week study ( NCT04403173 ) involving patients with hyperphosphatemia who were undergoing dialysis, the most common side effects included:
- Diarrhea: 15.0% of patients taking LY4006896 experienced diarrhea, compared to 1.7% on placebo.
- Nausea: 10.0% of patients taking LY4006896 experienced nausea, compared to 0.0% on placebo.
- Vomiting: 10.0% of patients taking LY4006896 experienced vomiting, compared to 0.0% on placebo.
- Hyperkalemia (high potassium levels): 6.7% of patients taking LY4006896 experienced hyperkalemia, compared to 0.0% on placebo.
- AV fistula complication: 5.0% of patients taking LY4006896 experienced an AV fistula complication, compared to 0.0% on placebo.
Clinical Trial Results
Results for Irritable Bowel Syndrome with Constipation (IBS-C)
In a 12-week, placebo-controlled study ( NCT04509490 ) involving patients with IBS-C, LY4006896 demonstrated significant improvements in symptoms compared to placebo.
- The primary goal of the study was to assess the Overall Responder (OR) rate, defined as a patient experiencing at least a 30% reduction in average weekly abdominal pain and an increase of at least one spontaneous bowel movement (SBM) per week from baseline, for at least 6 of the 12 treatment weeks. 44% of patients taking LY4006896 met this criteria, compared to 33% of patients on placebo.
- For abdominal pain relief, 50% of patients on LY4006896 reported a significant reduction in abdominal pain, compared to 38% on placebo.
- Regarding stool consistency, 50% of patients taking LY4006896 showed significant improvement in stool consistency, compared to 36% on placebo.
- Patients treated with LY4006896 experienced an average increase of 2.2 spontaneous bowel movements (SBMs) per week, compared to an increase of 1.0 SBMs per week for those on placebo. Similarly, complete spontaneous bowel movements (CSBMs) increased by 1.8 per week with LY4006896 versus 0.7 per week with placebo.
Results for Hyperphosphatemia in Patients Undergoing Dialysis
A 4-week, placebo-controlled study ( NCT04403173 ) investigated LY4006896 in patients with hyperphosphatemia (high phosphate levels) who were undergoing dialysis. The study found that LY4006896 significantly reduced serum phosphate levels.
- Patients taking LY4006896 experienced an average reduction in serum phosphate levels of 1.8 mg/dL from baseline, whereas patients on placebo saw a reduction of only 0.2 mg/dL. A reduction in serum phosphate levels indicates improvement.
- 60% of patients treated with LY4006896 achieved the target serum phosphate level of less than 5.5 mg/dL at week 4, compared to only 10% of patients on placebo.
Currently Recruiting Trials
Researchers are actively seeking volunteers to participate in clinical trials for LY4006896, an investigational drug being developed by Eli Lilly and Company. These studies are crucial for understanding how new treatments work and ensuring their safety and effectiveness for patients. One key study currently recruiting is "A Study of LY4006896 in Healthy Participants and Participants With Parkinson's Disease" (NCT06809400). This Phase 1 trial aims to evaluate the safety, tolerability, and how the body processes LY4006896 when administered intravenously. It also seeks to understand the drug's effects at different dosages compared to a placebo. The study is designed in two parts: Part A focuses on healthy participants, while Part B includes participants living with Parkinson's disease. The goal is to enroll approximately 127 participants across both groups, gathering essential data as LY4006896 progresses through its early development stages.Where to Participate
Participation in clinical trials for LY4006896 is currently available across a broad geographic area, with studies being conducted at 9 sites in 10 cities across 5 states. This widespread network helps ensure diverse representation among participants. Top locations where you can inquire about participating include:- Los Alamitos, California
- The Villages, Florida
- Naples, Florida
- Orlando, Florida
- Port Orange, Florida
- Spokane, Washington
- Farmington Hills, Michigan
- Austin, Texas
- Kirkland, Washington
- Maitland, Florida