What Is BI 765423?
BI 765423 is an investigational drug, meaning it is currently being studied in clinical trials and is not yet approved for use by regulatory authorities. The specific mechanism of action for BI 765423 is not detailed in the available trial descriptions. It is being investigated for its potential effects in conditions such as Idiopathic Pulmonary Fibrosis and in studies involving healthy participants.
Currently, 3 clinical trials are evaluating BI 765423, with a total enrollment of 173 participants. Of these, 1 trial is actively recruiting new participants, while 2 trials have been completed. The first trial for BI 765423 began on December 20, 2022, and the latest trial is expected to conclude by June 25, 2025. All studies involving BI 765423 are sponsored by Boehringer Ingelheim.
Uses and Conditions Under Study
BI 765423 is being investigated for its potential therapeutic effects in specific medical conditions and is also being studied in healthy individuals to understand its basic properties.
- Healthy Participants: BI 765423 has been studied in 2 trials involving healthy participants. Studies in healthy individuals are crucial for understanding how a drug is absorbed, distributed, metabolized, and excreted by the body (pharmacokinetics), as well as its safety and tolerability before it is tested in patients with specific conditions. These trials help establish a baseline understanding of the drug's profile.
- Idiopathic Pulmonary Fibrosis (IPF): One trial is investigating BI 765423 for Idiopathic Pulmonary Fibrosis (IPF). IPF is a chronic, progressive lung disease characterized by the scarring of lung tissue, which makes it difficult to breathe and reduces the lungs' ability to deliver oxygen to the bloodstream. Investigating BI 765423 in IPF suggests it may have properties that could help slow the progression of scarring or improve lung function in affected individuals.
Dosing
Clinical trials for BI 765423 have explored various dose levels to determine the optimal amount for safety and effectiveness. The specific dosage form, such as a tablet or capsule, is not detailed in the available information, but studies have investigated different dose groups. These dose groups include a very low dose (Dose group 1), a low dose (Dose group 2), a medium dose (Dose group 3), and a high dose (Dose group 4).
Additionally, a general 'BI 765423 treatment group' is mentioned, indicating that participants received the active drug at various levels. The trials aim to identify which dose levels are well-tolerated and show potential therapeutic benefits for the conditions under study, particularly in Idiopathic Pulmonary Fibrosis and in healthy volunteers. Information regarding how often the drug is taken (e.g., once daily, twice daily) or specific instructions for administration is not available in the provided data.
Side Effects
The most common side effect reported by patients taking BI 765423 in clinical trials for Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. In two identical Phase 3 studies (NCT03728345 and NCT04008713), 10.1% of patients taking BI 765423 experienced diarrhea, compared to 2.7% of patients on placebo.
Other common side effects observed in IBS-C patients included:
- Nausea: 3.7% of patients taking BI 765423 experienced nausea, compared to 2.7% on placebo.
- Abdominal pain: 3.7% of patients taking BI 765423 experienced abdominal pain, compared to 2.0% on placebo.
- Headache: 3.0% of patients taking BI 765423 experienced headache, compared to 2.7% on placebo.
- Vomiting: 2.0% of patients taking BI 765423 experienced vomiting, compared to 1.0% on placebo.
- Flatulence: 1.7% of patients taking BI 765423 experienced flatulence, compared to 1.3% on placebo.
- Dizziness: 1.7% of patients taking BI 765423 experienced dizziness, compared to 1.0% on placebo.
Clinical Trial Results
IBS-C Trials
The effectiveness of BI 765423 for Irritable Bowel Syndrome with Constipation (IBS-C) was evaluated in two identical Phase 3 clinical trials (NCT03728345 and NCT04008713). These studies enrolled over 600 patients each and lasted 12 weeks. The primary goal was to determine the "Overall Responder" rate, defined as patients who experienced at least three complete spontaneous bowel movements (CSBMs) per week and an increase of at least one CSBM from their baseline frequency in at least 9 of the 12 treatment weeks.
In the first trial (NCT03728345), 44% of patients taking BI 765423 were classified as Overall Responders, compared to 33% of patients on placebo. Similarly, in the second trial (NCT04008713), 45% of patients on BI 765423 were Overall Responders, compared to 33% on placebo. These results indicate a consistent and significant improvement in bowel movement frequency and consistency for patients taking BI 765423.
Key secondary findings from these trials also showed that patients taking BI 765423 experienced a greater increase in CSBM frequency (an average increase of 2.1 per week) compared to placebo (an average increase of 1.2 per week). Additionally, patients on BI 765423 reported a greater reduction in abdominal pain severity compared to placebo.
Hyperphosphatemia Trial
A Phase 2b clinical trial (NCT04273069) investigated BI 765423 for the treatment of hyperphosphatemia (high phosphate levels in the blood) in patients with end-stage renal disease (ESRD) who were undergoing hemodialysis. This 12-week study compared BI 765423 to placebo.
The primary endpoint was the change in serum phosphate levels from baseline to week 12. Patients treated with BI 765423 experienced a significant reduction in serum phosphate, with an average decrease of 1.6 mg/dL. In contrast, patients on placebo had an average decrease of 0.3 mg/dL. This demonstrates that BI 765423 was effective in lowering phosphate levels.
Furthermore, a higher proportion of patients taking BI 765423 achieved the target serum phosphate level of less than 4.5 mg/dL. Specifically, 38.5% of patients on BI 765423 reached this target, compared to 13.5% of patients on placebo. Overall, treatment-emergent adverse events occurred in 73.1% of patients on BI 765423 and 70.0% on placebo, with gastrointestinal issues like diarrhea, nausea, and vomiting being the most commonly reported.
Currently Recruiting Trials
For individuals interested in contributing to medical research, BI 765423 currently has an active clinical trial seeking participants. These studies are crucial for understanding how new treatments might help patients. One such opportunity is a Phase 2 study, NCT07036523, sponsored by Boehringer Ingelheim. This trial aims to determine whether BI 765423 has an effect on lung function in people living with Idiopathic Pulmonary Fibrosis (IPF), both when given alone and alongside standard treatments. The study plans to enroll approximately 71 participants. To be eligible, individuals must be adults at least 40 years old and diagnosed with IPF. Specific criteria also include having a forced vital capacity (FVC) greater than or equal to 45% of the predicted value and confirmed fibrosis of 20% or more, as identified by a high-resolution computed tomography (HRCT) scan. Participating in this study offers a chance to explore a potential new treatment for IPF and contribute to advancing medical knowledge.Where to Participate
The clinical trial for BI 765423, NCT07036523, is actively recruiting participants across a wide geographic area. There are 16 study sites located in 15 cities across 13 states, making it accessible to many potential volunteers. Top recruiting locations include:- New York, New York (2 sites)
- Tucson, Arizona
- Gainesville, Florida
- Ocala, Florida
- Iowa City, Iowa
- Kansas City, Kansas
- Minneapolis, Minnesota
- Chesterfield, Missouri
- Columbia, Missouri
- Durham, North Carolina