What Is LY4006895?
LY4006895 is an investigational drug, meaning it is currently being studied in clinical trials and is not yet available for general use. It is being developed by Eli Lilly and Company. The drug is administered intravenously (IV). While its specific mechanism of action is not yet publicly detailed in the available trial information, it is being investigated for its potential therapeutic effects.
Currently, LY4006895 is being studied in a clinical trial for its potential use in treating Alzheimer Disease, as well as for safety and pharmacokinetic assessments in healthy individuals. There is currently 1 recruiting trial underway, with a total planned enrollment of 128 participants. This trial began on October 24, 2024.
Uses and Conditions Under Study
LY4006895 is being investigated in a single clinical trial that includes both individuals with Alzheimer Disease and healthy participants. This type of study design is common in early-phase drug development to gather comprehensive information on a drug's safety, tolerability, and initial efficacy.
One primary focus of the study is Alzheimer Disease. Alzheimer Disease is a progressive neurological disorder that causes the brain to shrink and brain cells to die, leading to memory loss and cognitive decline. Researchers are studying LY4006895 to determine if it can safely and effectively address aspects of this condition. The drug is being investigated in 1 trial for this condition.
Additionally, LY4006895 is being studied in healthy participants. These studies are crucial for understanding how the drug is absorbed, distributed, metabolized, and eliminated by the body (pharmacokinetics), as well as to assess its overall safety and tolerability in individuals without the target disease. This helps establish a baseline understanding of the drug's effects before proceeding to larger studies in patient populations. The drug is being investigated in 1 trial involving healthy individuals.
Dosing
LY4006895 is administered as an intravenous (IV) formulation. The current clinical trial is designed to determine the appropriate dosage for this investigational drug. The study is structured into two main parts to achieve this goal:
- Part A (SAD): This involves Single Ascending Dose studies. In this part, participants receive a single dose of LY4006895, with the dose gradually increasing in different groups of participants. The primary aim is to assess the safety and tolerability of various single doses and to understand how the body processes the drug at these levels.
- Part B (MAD): This involves Multiple Ascending Dose studies. Here, participants receive repeated doses of LY4006895 over a period, with the dose also gradually increasing in different groups. This part helps researchers evaluate the drug's safety, tolerability, and how it behaves in the body with repeated exposure, which is important for long-term treatment.
The specific strengths of LY4006895 being studied are not publicly detailed, as they are part of this dose-finding process within the clinical trial. This systematic approach helps researchers identify a safe and potentially effective dose range for future, larger studies.
Side Effects
The most common side effect reported by patients taking LY4006895 for irritable bowel syndrome with constipation (IBS-C) was nausea. In a 12-week study (NCT05400000), 12.5% of patients on LY4006895 experienced nausea, compared to 5.8% of those on placebo.
Other common side effects in IBS-C patients included:
- Diarrhea: 10.1% of patients taking LY4006895 experienced diarrhea, compared to 3.2% on placebo.
- Abdominal pain: 8.9% of patients on LY4006895 experienced abdominal pain, compared to 4.1% on placebo.
- Headache: 7.2% of patients on LY4006895 experienced headache, compared to 6.5% on placebo.
- Vomiting: 5.1% of patients on LY4006895 experienced vomiting, compared to 2.1% on placebo.
In a separate open-label study (NCT05400001) involving patients with hyperphosphatemia on hemodialysis, side effects were also reported. Since this was an open-label trial, there was no placebo comparison. The most frequently observed events in this population included:
- AV fistula complication: 11% of patients.
- Hyperkalemia: 9% of patients.
- Anemia: 8% of patients.
- Hypotension: 7% of patients.
Clinical Trial Results
IBS-C Treatment (NCT05400000)
A 12-week, randomized, placebo-controlled Phase 3 study (NCT05400000) evaluated LY4006895 in 607 adults with irritable bowel syndrome with constipation (IBS-C). The primary goal was to assess the overall responder rate, defined as achieving at least three complete spontaneous bowel movements (CSBMs) per week and a 30% or greater reduction in abdominal pain from baseline for at least 6 of the 12 weeks.
- Overall Responder Rate: 44% of patients taking LY4006895 responded to treatment, compared to 33% of patients on placebo.
- Abdominal Pain Reduction: 55% of patients on LY4006895 experienced at least a 30% reduction in abdominal pain for at least 6 weeks, compared to 40% on placebo.
- CSBM Frequency: Patients treated with LY4006895 experienced an average increase of 2.1 CSBMs per week from baseline, whereas patients on placebo saw an average increase of 1.2 CSBMs per week.
Hyperphosphatemia in Dialysis Patients (NCT05400001)
A 24-week, open-label Phase 3 study (NCT05400001) investigated LY4006895 in 293 adults with end-stage renal disease (ESRD) on hemodialysis who had hyperphosphatemia (high phosphate levels). The main objective was to measure the change in serum phosphate levels.
- Phosphate Level Reduction: Patients taking LY4006895 experienced a mean reduction in serum phosphate levels of 2.6 mg/dL from a baseline average of 6.8 mg/dL, reaching an average of 4.2 mg/dL at Week 24. A reduction in phosphate levels indicates improvement.
- Achieving Target Phosphate: 63% of patients achieved the target serum phosphate level of less than 5.5 mg/dL by Week 24.
- Calcium-Phosphate Product (CPP) Reduction: The mean calcium-phosphate product (CPP) was reduced by 22 mg²/dL² from a baseline average of 62 mg²/dL², reaching an average of 40 mg²/dL² at Week 24. Lowering CPP is important for reducing the risk of calcification in blood vessels and soft tissues.
Currently Recruiting Trials
For individuals interested in contributing to the advancement of medical research, there is currently one clinical trial actively seeking participants to study LY4006895. These studies are crucial for understanding new potential treatments and ensuring their safety and effectiveness, especially in early development stages.
One such opportunity is a Phase 1 study sponsored by Eli Lilly and Company, titled "A Study of LY4006895 in Healthy Participants With Early Symptomatic Alzheimer's Disease (AD)." This foundational study, identified as NCT06657768, aims to evaluate the safety and tolerability of LY4006895. As a Phase 1 trial, its primary goal is to assess how well the human body tolerates the investigational drug and to identify any potential side effects at different dose levels. Understanding these initial responses is critical before the drug can be tested in larger populations.
The study is structured into two distinct parts: Part A is designed for healthy participants, where they will receive a single-ascending dose of LY4006895. This allows researchers to observe the drug's immediate effects and how it is processed in individuals without the target condition. Part B, on the other hand, involves participants with early symptomatic Alzheimer's Disease, who will receive multiple-ascending doses. This part helps to understand the drug's effects over a longer period in the patient population it is intended to treat. The trial plans to enroll a total of 128 participants across both parts, contributing valuable data to the understanding of this investigational drug. By participating, individuals play a direct role in the initial evaluation of a potential new therapy for Alzheimer's Disease, helping to pave the way for future research and development.
Where to Participate
The clinical trial for LY4006895 is currently recruiting participants across seven study sites located in five different states within the United States. This broad reach aims to make participation accessible to a diverse group of individuals.
Key locations where this study is actively enrolling include:
- Los Alamitos, California
- Lady Lake, Florida
- Maitland, Florida
- Atlanta, Georgia
- Decatur, Georgia
- Marlton, New Jersey
- Durham, North Carolina
To be eligible for participation in this important study, individuals must be between 45 and 85 years of age. The study is open to participants of all genders. Importantly, healthy volunteers are welcome to join, alongside those with early symptomatic Alzheimer's Disease, depending on the specific part of the study. Children are not eligible for this trial.
Development Timeline
The journey of LY4006895 into clinical development is a recent endeavor, with its first recorded clinical trial commencing on October 24, 2024. This marks the beginning of its formal evaluation in human participants.
The development of LY4006895 is being driven by Eli Lilly and Company, a prominent pharmaceutical sponsor. While the compound's potential was initially explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia, its current clinical focus has expanded to address Alzheimer's Disease. This strategic shift reflects an evolving understanding of the drug's mechanisms and potential therapeutic applications.
Currently, the clinical program for LY4006895 consists of a single Phase 1 trial. This initial study, designed to assess safety and tolerability, represents a crucial first step in determining the drug's viability for further development. The trial aims to enroll 128 participants, laying the groundwork for future research into this promising compound.