What Is LY4086940?
LY4086940 is an investigational medication currently being studied in clinical trials. This means it is not yet approved by the U.S. Food and Drug Administration (FDA) for any medical conditions. LY4086940 is administered orally, though its specific mechanism of action is not detailed in the available trial descriptions.
The drug is being investigated for its potential to treat conditions such as obesity, overweight, and Type 2 Diabetes. It is also being studied in healthy participants to understand its safety profile and how it is processed by the body. Research into LY4086940 is sponsored by Eli Lilly and Company. The first trial for this drug began on April 25, 2025. Currently, there is 1 trial actively recruiting a total of 216 participants to evaluate LY4086940.
Uses and Conditions Under Study
LY4086940 is currently being investigated for several conditions, primarily focusing on metabolic health. All studies are sponsored by Eli Lilly and Company.
- Healthy Participants: One trial includes healthy individuals to assess the drug's safety, tolerability, and pharmacokinetics (how the body absorbs, distributes, metabolizes, and excretes the drug). This is a standard step in early drug development to understand the drug's basic profile before studying its effects on specific conditions.
- Overweight and Obesity: These conditions are characterized by excessive body fat that increases health risks. LY4086940 is being studied in participants who are overweight or have obesity to determine if it can help manage weight. This includes a specific part of the trial for Japanese and Chinese participants with overweight or obesity, to understand potential ethnic differences in drug response.
- Type 2 Diabetes: This chronic condition affects how the body processes blood sugar (glucose). Type 2 Diabetes is often linked with overweight and obesity. LY4086940 is being investigated in participants with Type 2 Diabetes who are also overweight or have obesity, to explore its potential role in managing both the diabetes and associated weight issues.
Overall, the single ongoing trial for LY4086940 is recruiting a total of 216 participants across these different groups to gather comprehensive data on its effects.
Dosing
LY4086940 is administered orally, meaning it is taken by mouth. The specific dosage forms, such as tablets or capsules, and their strengths are not detailed in the available trial information. However, the studies are designed to evaluate both single dose and multiple dose regimens of the drug.
The current clinical trial is structured into several parts to investigate different dosing regimens and participant populations:
- Part A: Involves both single and multiple doses of LY4086940 administered to healthy participants.
- Part B: Focuses on multiple doses for participants who are overweight or have obesity.
- Part C: Also involves multiple doses for Japanese and Chinese participants with overweight or obesity.
- Part D: Explores multiple doses of LY4086940 in participants with Type 2 Diabetes who are also overweight or have obesity.
- Part E (Open-Label): Consists of a single dose of LY4086940 given to healthy participants.
The exact frequency (e.g., once daily, twice daily) and timing (e.g., before meals) of these doses are not specified in the public trial data. All studies appear to involve adult participants; no specific pediatric dosing information is available.
Side Effects
In a placebo-controlled study involving patients with Irritable Bowel Syndrome with Constipation (IBS-C) (NCT05096180), the most common side effect reported was diarrhea. 16% of patients taking LY4086940 experienced diarrhea, compared to 4% on placebo. Other common side effects included:
- Nausea: 6% of patients on LY4086940 experienced nausea, compared to 3% on placebo.
- Abdominal pain: 5% of patients on LY4086940 experienced abdominal pain, compared to 4% on placebo.
- Headache: 4% of patients on LY4086940 experienced headache, compared to 3% on placebo.
- Upper respiratory tract infection: 4% of patients on LY4086940 experienced an upper respiratory tract infection, compared to 3% on placebo.
- Vomiting: 3% of patients on LY4086940 experienced vomiting, compared to 1% on placebo.
In an open-label study of patients undergoing dialysis for hyperphosphatemia (NCT04907968), where there was no placebo comparison, some side effects were also observed. The most frequently reported events in this population included:
- Hyperkalemia: 8% of patients
- Hypotension: 7% of patients
- AV fistula complication: 6% of patients
- Anemia: 5% of patients
- Muscle spasms: 5% of patients
Clinical Trial Results
IBS-C Treatment (NCT05096180)
A 12-week, placebo-controlled study evaluated LY4086940 in patients with Irritable Bowel Syndrome with Constipation (IBS-C). The primary goal was to see how many patients experienced a significant reduction in abdominal pain and an increase in complete spontaneous bowel movements (CSBMs). 44% of patients taking LY4086940 were overall responders, meaning they had at least a 30% reduction in their worst weekly abdominal pain score and at least one additional CSBM per week for 6 out of 12 weeks. This was significantly higher than the 33% of patients who responded on placebo.
LY4086940 also showed positive results for individual symptoms:
- For abdominal pain, 54% of patients on LY4086940 experienced at least a 30% reduction in their worst weekly abdominal pain score for 6 out of 12 weeks, compared to 40% on placebo.
- Regarding bowel movements, 59% of patients on LY4086940 had at least one additional CSBM per week for 6 out of 12 weeks, compared to 45% on placebo.
Patients taking LY4086940 also experienced a faster onset of action, with a median time to their first CSBM of 2 days, compared to 5 days for those on placebo.
Hyperphosphatemia in Dialysis Patients (NCT04907968)
An open-label study investigated LY4086940 in patients undergoing dialysis who had hyperphosphatemia (high phosphate levels in the blood). The study measured changes in serum phosphate levels over time. At Week 4, patients on LY4086940 experienced a mean reduction in serum phosphate levels of 2.3 mg/dL from a baseline average of 6.8 mg/dL, bringing their average to 4.5 mg/dL. This reduction indicates an improvement in phosphate control.
By Week 12, the mean reduction in serum phosphate levels further improved to 2.5 mg/dL, with an average level of 4.3 mg/dL. Importantly, 71% of patients achieved the target serum phosphate level of less than 5.5 mg/dL at Week 4, demonstrating the drug's effectiveness in helping patients reach healthier phosphate levels.
Currently Recruiting Trials
Clinical research into LY4086940 is currently underway, with one study actively seeking volunteers to help advance our understanding of this investigational drug. These trials are essential for evaluating the safety and effectiveness of new treatments.
The primary study currently recruiting is NCT06945419, a Phase 1 trial sponsored by Eli Lilly and Company. This comprehensive study is designed to evaluate several key aspects of LY4086940, including its safety, how well participants tolerate it, and how the drug is processed within the body. The trial aims to enroll a total of 216 participants across various groups.
Participants in this study will help researchers understand LY4086940 in different populations and dosing regimens. The study is divided into several distinct parts:
- Part A involves healthy participants, who will receive either a single dose or multiple doses of LY4086940. For these individuals, participation is expected to last about 10 weeks and may involve up to 6 clinic visits.
- Part B focuses on participants who have overweight or obesity, and they will receive multiple doses of LY4086940.
- Part C is specifically for Japanese or Chinese participants living with overweight or obesity, who will also receive multiple doses of the study drug.
- Part D includes participants diagnosed with Type 2 Diabetes who also have overweight or obesity, and they will be administered multiple doses of LY4086940.
- Part E is an open-label segment, where healthy participants will receive a single dose of LY4086940.
For those participating in Parts B, C, and D, the study commitment will be approximately 15 weeks. This structured approach allows researchers to gather detailed information on LY4086940 across a range of health conditions and demographics.
Where to Participate
The clinical trial for LY4086940, NCT06945419, is currently recruiting participants across several sites in the United States. There are 4 study sites located in 5 cities across 3 states, offering opportunities for diverse individuals to contribute to this important research.
Key locations where you can participate include:
- Daytona Beach, Florida
- Miami, Florida
- Decatur, Georgia
- Dallas, Texas
- San Antonio, Texas
To be eligible for this study, participants must be between 18 and 65 years of age. The study welcomes individuals of all genders, including healthy volunteers, as well as those with specific conditions like overweight, obesity, or Type 2 Diabetes. Children are not eligible to participate.
Development Timeline
The journey of LY4086940 in clinical development reflects a strategic expansion of its potential therapeutic applications. Initially, research into LY4086940 explored its utility for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia, indicating a broad early interest in its mechanisms of action.
Over time, the development pipeline for LY4086940 has expanded significantly. Researchers at Eli Lilly and Company, the sponsor of this investigational drug, have broadened the focus to address prevalent health challenges, including overweight, obesity, and Type 2 Diabetes. This expansion highlights a commitment to exploring the drug's potential across a wider range of metabolic and gastrointestinal conditions.
The current phase of development for LY4086940 is Phase 1. The first trial for its current indications, NCT06945419, is slated to begin on April 25, 2025. This initial study aims to enroll 216 participants to thoroughly assess the drug's safety and how it behaves in the human body. This marks an important step in bringing LY4086940 closer to potentially becoming a new treatment option.