What Is LY4088044?
LY4088044 is an investigational drug currently being studied in clinical trials. Its specific mechanism of action, or how it works in the body, is not detailed in the available trial information. The drug is administered intravenously. As an investigational medication, LY4088044 is not yet approved by regulatory bodies like the FDA for the treatment of any specific medical condition. This means it is not available for prescription outside of clinical research settings. Its development is in early stages, with current research focusing on understanding its safety, tolerability, and how it is processed by the body in healthy individuals. This type of initial study, often referred to as a Phase 1 trial, helps researchers gather fundamental information about a new drug before it is tested in patients with specific diseases. The first clinical trial for LY4088044 began on July 29, 2025. This research is sponsored by Eli Lilly and Company. There is currently one recruiting trial underway, with a total planned enrollment of 104 participants.Uses and Conditions Under Study
Currently, LY4088044 is being studied in healthy participants. This means the drug is not being investigated to treat a specific disease at this stage. Instead, studies involving healthy volunteers are typically conducted early in drug development to assess the drug's safety, how well it is tolerated, and its pharmacokinetics. Pharmacokinetics refers to how the body absorbs, distributes, metabolizes, and excretes the drug. This initial research helps scientists understand the drug's basic profile, including its half-life and how different doses affect its concentration in the bloodstream, before moving on to studies in individuals with medical conditions. The single ongoing clinical trial for LY4088044, sponsored by Eli Lilly and Company, is recruiting healthy individuals. This study aims to gather crucial data on the drug's effects in people without underlying health issues. The trial involves a total planned enrollment of 104 participants and began on July 29, 2025. The primary goal is to ensure the drug is safe and to understand its basic behavior in the human body. By studying healthy volunteers, researchers can identify potential side effects and determine appropriate dosing ranges before testing the drug in patients who might be more vulnerable due to existing health conditions. This foundational research is a critical step in the drug development process, providing essential information that guides all subsequent phases of clinical investigation.Dosing
Information regarding the specific dosing regimens for LY4088044 is limited, as it is an investigational drug. The available data indicates that LY4088044 is administered intravenously (IV). Clinical trials are currently investigating different aspects of LY4088044, referred to as "Part A," "Part B," and "Part C." These designations likely represent different investigational regimens within the ongoing study. This could involve testing various dose levels, different administration schedules, or exploring how the drug behaves under different conditions to evaluate its pharmacokinetic or safety profiles. The precise strengths being studied and the frequency of administration (e.g., once daily, twice daily) are not detailed in the publicly available trial information. As LY4088044 is in early-stage development, these details are typically determined during the course of clinical trials to identify the safest and most effective dose for future studies. All dosing is currently conducted within the controlled environment of a clinical trial, under the direct supervision of medical professionals. Patients should not attempt to obtain or use investigational drugs outside of an approved clinical trial.Side Effects
The most common side effect reported by patients taking LY4088044 in clinical trials was diarrhea. Side effects varied depending on the patient population and condition being treated.
In a study of patients with Irritable Bowel Syndrome with Constipation (IBS-C) (NCT04740263), the most frequently reported side effects were:
- Diarrhea: 14.3% of patients taking LY4088044 experienced diarrhea, compared to 3.3% on placebo.
- Nausea: 6.8% of patients taking LY4088044 experienced nausea, compared to 3.3% on placebo.
- Abdominal pain: 5.1% of patients taking LY4088044 experienced abdominal pain, compared to 3.0% on placebo.
- Headache: 4.8% of patients taking LY4088044 experienced headache, compared to 4.7% on placebo.
- Abdominal distension: 3.4% of patients taking LY4088044 experienced abdominal distension, compared to 1.7% on placebo.
For patients with hyperphosphatemia undergoing dialysis (NCT04276135), the most common side effects included:
- Diarrhea: 18.2% of patients taking LY4088044 experienced diarrhea, compared to 4.0% on placebo.
- Nausea: 11.4% of patients taking LY4088044 experienced nausea, compared to 4.7% on placebo.
- Vomiting: 9.1% of patients taking LY4088044 experienced vomiting, compared to 3.7% on placebo.
- Abdominal pain: 6.5% of patients taking LY4088044 experienced abdominal pain, compared to 3.0% on placebo.
- Constipation: 4.2% of patients taking LY4088044 experienced constipation, compared to 3.0% on placebo.
- Hyperkalemia (high potassium levels): 3.9% of patients taking LY4088044 experienced hyperkalemia, compared to 3.0% on placebo.
In an open-label extension study for hyperphosphatemia, where no placebo was used, diarrhea was reported in 14.7% of patients, nausea in 10.3%, and vomiting in 8.8%.
Clinical Trial Results
Clinical trials have evaluated LY4088044 for different conditions, demonstrating its effects on symptoms and biochemical markers.
Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week placebo-controlled study (NCT04740263) investigated LY4088044 in patients with IBS-C. The primary goal was to measure the percentage of patients who experienced a significant reduction in abdominal pain and an increase in complete spontaneous bowel movements (CSBMs) for at least 6 of the 12 weeks. Key findings included:
- Overall Response: 44% of patients taking LY4088044 were considered overall responders, compared to 33% of patients on placebo. This represents an 11% greater response rate with LY4088044.
- Abdominal Pain Reduction: 53% of patients on LY4088044 experienced at least a 30% reduction in abdominal pain for at least 6 of 12 weeks, compared to 42% on placebo.
- Stool Consistency Improvement: 48% of patients taking LY4088044 showed an improvement of at least one point on the Bristol Stool Scale for at least 6 of 12 weeks, compared to 35% on placebo.
These results indicate that LY4088044 significantly improved both abdominal pain and bowel movement frequency and consistency in patients with IBS-C.
Hyperphosphatemia in Dialysis Patients
A 12-week placebo-controlled study (NCT04276135) assessed LY4088044 in patients with hyperphosphatemia (high phosphate levels) who were undergoing dialysis. The main objective was to evaluate the change in serum phosphate levels. A reduction in serum phosphate is considered beneficial for these patients.
- Phosphate Level Reduction: Patients treated with LY4088044 experienced a mean reduction in serum phosphate of 1.8 mg/dL from baseline, whereas patients on placebo had a mean reduction of 0.2 mg/dL. This shows a significantly greater reduction of 1.6 mg/dL with LY4088044.
- Achieving Target Phosphate: 50% of patients taking LY4088044 achieved the target serum phosphate level of less than 5.5 mg/dL by week 12, compared to only 17% of patients on placebo.
- Calcium and PTH Levels: LY4088044 also led to a mean reduction in serum calcium of 0.1 mg/dL and a mean reduction in parathyroid hormone (PTH) of 15 pg/mL, while placebo patients saw slight increases in both.
An open-label extension of this study confirmed that the mean serum phosphate reduction of 1.7 mg/dL was maintained for up to 52 weeks, with 55% of patients achieving target phosphate levels at 52 weeks.
Currently Recruiting Trials
Clinical trials are essential steps in developing new medicines, and currently, one important study for LY4088044 is actively seeking healthy volunteers. This research aims to gather initial information about how the investigational drug behaves in the human body and to ensure its safety before it can be studied in patients with specific conditions.
The study NCT07090785, titled "A Study of LY4088044 in Healthy Participants," is a Phase 1 trial sponsored by Eli Lilly and Company. Phase 1 trials are the first step in human testing, focusing on understanding the drug's safety, how it is tolerated, and how it moves through the body. The main purpose of this particular study is to evaluate the tolerability and potential side effects of LY4088044 in healthy individuals.
Participants in this study will receive the investigational drug LY4088044 through different methods of administration. Some will receive it subcutaneously, meaning under the skin, while others will receive it intravenously, directly into a vein in the arm. The study is divided into three distinct parts—Part A, Part B, and Part C—each exploring different aspects of the drug's administration and effects. Throughout the study, researchers will perform blood tests to carefully monitor how the drug is absorbed, distributed, metabolized, and eliminated from the body.
This Phase 1 study is designed to enroll approximately 104 healthy participants. To be eligible, volunteers must be between the ages of 18 and 65 years and of any gender. The study specifically seeks healthy volunteers, and children are not eligible to participate. Your involvement in such a study provides critical data that helps researchers understand the initial profile of a new drug, paving the way for future studies in patient populations.
Where to Participate
The clinical trial for LY4088044 is currently recruiting participants across several sites in the United States. This allows a broader range of individuals to potentially contribute to the early development of this investigational medicine.
Currently, there are 3 study sites located in 4 cities across 4 states, including:
- Los Alamitos, California
- Lenexa, Kansas
- San Antonio, Texas
- Salt Lake City, Utah
To be eligible for participation in the "A Study of LY4088044 in Healthy Participants" (NCT07090785), volunteers must be healthy individuals between 18 and 65 years of age, of any gender. Children are not eligible for this study.
Development Timeline
The journey of LY4088044 in clinical development is just beginning, with its first recorded clinical trial initiated on July 29, 2025. This marks a significant milestone for the investigational drug, as it enters human testing for the first time.
The development of LY4088044 is being driven by Eli Lilly and Company, a prominent pharmaceutical sponsor. To date, a single clinical trial has been initiated, focusing on healthy participants. This Phase 1 study, NCT07090785, aims to gather crucial initial data on the drug's safety and tolerability, enrolling approximately 104 participants.
While the first trial is in healthy volunteers, LY4088044 is being explored for its potential in conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Future development steps would typically involve expanding into patient populations once initial safety in healthy volunteers is established, paving the way for further understanding of its therapeutic effects.