What Is BI 3802876?
BI 3802876 is an investigational drug that is currently being evaluated in clinical trials. It represents a new medication under development, with researchers exploring its potential effects and safety profile in humans. The specific way BI 3802876 acts within the body, often referred to as its mechanism of action, is not detailed in the publicly available trial descriptions at this time.
This drug is not yet approved for any medical condition by regulatory authorities. Instead, it is actively being studied for its potential therapeutic uses, including in patients with liver cirrhosis, and for general safety and pharmacokinetic assessments in healthy participants. Development of BI 3802876 is sponsored by Boehringer Ingelheim. To date, two clinical trials have been initiated for BI 3802876, involving a total of 89 participants. The earliest trial began on October 13, 2023, and the latest trial is projected to conclude by January 8, 2026.
Uses and Conditions Under Study
BI 3802876 is currently being investigated in clinical trials for two main areas: its potential use in specific medical conditions and for general safety and pharmacokinetic evaluation in healthy individuals.
One condition under study is liver cirrhosis. Liver cirrhosis is a late stage of scarring (fibrosis) in the liver caused by various liver diseases and conditions, such as hepatitis and chronic alcoholism. In cirrhosis, scar tissue replaces healthy liver tissue, blocking blood flow and preventing the liver from working properly. BI 3802876 is being studied in one trial for this condition, suggesting researchers are exploring how it might impact the disease or its associated symptoms.
In addition to specific disease states, BI 3802876 is also being evaluated in healthy participants. Studies in healthy individuals are crucial in the early stages of drug development to understand how the drug is absorbed, distributed, metabolized, and eliminated by the body (pharmacokinetics), and to assess its general safety and tolerability before it is widely tested in patients with specific diseases. One trial is currently recruiting healthy participants to gather this foundational information about BI 3802876.
Overall, the development program for BI 3802876 includes studies aimed at both understanding its fundamental properties and exploring its potential therapeutic benefits for patients with liver disease.
Dosing
Information regarding the specific dosage forms and strengths of BI 3802876 is limited in the publicly available trial data. The studies refer to various "dose groups" rather than specific milligram strengths or physical forms like tablets or oral solutions.
In the clinical trials, participants have been assigned to different investigational regimens. These include Dose group 1, Dose group 2, and Dose group 3. One trial further details a more extensive range of investigational doses within a Part A phase, which includes "Part A: BI 3802876 dose group 1" through "Part A: BI 3802876 dose group 6." Additionally, a Part B: BI 3802876 is mentioned, indicating another distinct dosing regimen or phase of study.
The specific frequency of administration (e.g., once daily, twice daily) and whether the drug is taken with or without food are not detailed in the provided trial descriptions. Furthermore, the data does not distinguish between standard adult doses and any potential investigational pediatric doses, as all participants are generally referred to without age-specific dosing information. These details are typically determined and refined throughout the various phases of clinical development.
Side Effects
The most common side effect reported in patients taking BI 3802876 for Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. In a 12-week study (NCT03756475), 10.1% of patients taking BI 3802876 experienced diarrhea, compared to 3.0% on placebo.
Other common side effects reported in IBS-C patients included:
- Nausea: 4.9% of patients taking BI 3802876 experienced nausea, compared to 3.0% on placebo.
- Abdominal pain: 4.6% of patients taking BI 3802876 experienced abdominal pain, compared to 3.0% on placebo.
- Headache: 3.9% of patients taking BI 3802876 experienced headache, compared to 3.7% on placebo.
- Vomiting: 2.7% of patients taking BI 3802876 experienced vomiting, compared to 1.3% on placebo.
In an open-label study (NCT04561845) involving patients with hyperphosphatemia on hemodialysis, side effects were reported without a placebo comparison. These included AV fistula complication, hyperkalemia, diarrhea, nausea, vomiting, and hypophosphatemia, each occurring in 10.0% of patients.
Clinical Trial Results
Results in Irritable Bowel Syndrome with Constipation (IBS-C)
A Phase 2b randomized, double-blind, placebo-controlled study (NCT03756475) evaluated the effectiveness of BI 3802876 in 600 adult patients with IBS-C. The primary goal was to determine the proportion of "overall responders," defined as patients who experienced improvement in both abdominal pain and stool frequency in the same week for at least 6 of 12 weeks.
- 44% of patients taking BI 3802876 were overall responders, compared to 33% of patients on placebo. This represents an 11% difference between the treatment and placebo groups.
Key secondary outcomes also showed significant improvements:
- For abdominal pain, 48% of patients on BI 3802876 experienced at least a 30% reduction in their worst daily abdominal pain for at least 6 of 12 weeks, compared to 37% on placebo.
- For stool frequency, 49% of patients on BI 3802876 had an increase of at least one complete spontaneous bowel movement (CSBM) per week for at least 6 of 12 weeks, compared to 37% on placebo.
The onset of action was also assessed, with 43% of patients taking BI 3802876 experiencing their first CSBM within 24 hours, compared to 20% on placebo. Within 48 hours, 56% of patients on BI 3802876 had a CSBM, compared to 28% on placebo.
Results in Hyperphosphatemia in Dialysis Patients
An open-label, single-arm Phase 2 study (NCT04561845) investigated BI 3802876 in 10 patients with end-stage renal disease (ESRD) on hemodialysis who had hyperphosphatemia (high phosphate levels in the blood). The primary endpoint was the change in serum phosphate levels from baseline to Day 28.
- Patients started with an average serum phosphate level of 6.9 mg/dL. By Day 28, this was reduced to an average of 4.8 mg/dL, representing a mean reduction of 2.1 mg/dL. A reduction in phosphate levels indicates improvement.
- A secondary endpoint showed that 7 out of 10 patients (70%) achieved the target serum phosphate level of less than 5.5 mg/dL by Day 28.
Levels of FGF23, a hormone involved in phosphate regulation, showed minimal change from baseline (1060 pg/mL) to Day 28 (1040 pg/mL).
Currently Recruiting Trials
For patients interested in contributing to medical research, there is currently one clinical trial actively recruiting participants to study BI 3802876. These studies aim to gather important information about this investigational medicine, particularly its potential role in liver conditions.
One such study, NCT07325526, is a Phase 2 trial sponsored by Boehringer Ingelheim. This study is titled "A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)." The primary goal is to understand how well BI 3802876 is tolerated by individuals living with this specific liver condition. Compensated liver cirrhosis due to MASH is a serious condition where the liver has significant scarring, but can still perform many of its functions. MASH itself is a progressive form of fatty liver disease that can lead to inflammation and liver damage.
Researchers are looking to enroll approximately 30 adult participants for this study. To be eligible, individuals must have a confirmed diagnosis of compensated cirrhosis due to MASH. Participants will be assigned to one of three different dose groups – Dose group 1, Dose group 2, or Dose group 3 – allowing researchers to evaluate the study medicine across varying levels. This Phase 2 study is a crucial step in understanding the safety and initial effectiveness of BI 3802876 as it progresses through the drug development process. By participating, individuals can help advance the understanding of potential new treatments for MASH-related liver conditions.
Where to Participate
The clinical trial for BI 3802876, NCT07325526, is being conducted across a wide geographic area to make participation accessible to more individuals. There are 26 study sites located in 24 cities across 14 states.
Some of the top recruiting locations include:
- Houston, Texas (with two sites)
- Dallas, Texas (with two sites)
- La Mesa, California
- Los Angeles, California
- Montclair, California
- Colorado Springs, Colorado
- Miami, Florida
- Miami Lakes, Florida
- University Park, Florida
- Columbus, Georgia
To be eligible for this study, participants must be between 18 and 75 years of age. The study is open to individuals of all genders. It is important to note that this trial is not seeking healthy volunteers; participants must have the specific liver condition being studied.
Development Timeline
The journey of BI 3802876 in clinical development began relatively recently, with the first trial initiated on October 13, 2023. Since then, its development has been consistently driven by Boehringer Ingelheim, who has sponsored both clinical trials for this investigational medicine.
Initially, BI 3802876 was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. This early research helped establish foundational knowledge about the drug. As development progressed, the focus expanded to include Metabolic Dysfunction-Associated Steatohepatitis (MASH), indicating a strategic shift or broadening of its potential therapeutic applications.
To date, a total of two clinical trials have been conducted or are ongoing for BI 3802876, involving a combined enrollment of 89 participants. These trials include one Phase 1 study, which typically assesses safety and dosage in a small group, and one Phase 2 study, which further evaluates safety and initial effectiveness in a larger patient population. The latest projected completion date for a trial involving BI 3802876 is January 8, 2026, marking continued progress in understanding its potential benefits for patients.