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NCT06957756 · ClinicalTrials.gov registry record · Phase 1
A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems
A Phase 1 study of Hepatic Insufficiency, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 3
- Study locations
NCT06957756 is a Phase 1 study of Hepatic Insufficiency that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 44 participants, above the 37-participant average among 14 other Hepatic Insufficiency trials with a reported enrollment target (19% higher). The trial reports 3 study locations across 3 states.
The verdict
NCT06957756, a Phase 1 study of Hepatic Insufficiency, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m2 can take part. This study includes people with mild, moderate, and severe liver problems, and people without liver problems as a matching control. The purpose of this study is to find out how mild, moderate, and severe liver problems affect how the body handles a medicine called BI 1584862. Participants take BI 1584862 once. Participants with liver problems are treated in a step-by-step approach with a few days in between for the doctors to review the data and to make sure the participants can tolerate the treatment. Participants may continue their regular treatment for their liver problems during the study. Participants are in the study for about 5 weeks. During this time, they visit the study site 3 times. This also includes an overnight stay for 4 nights. During study visits, the doctors regularly check participants' health and take note of any unwanted effects. To assess the study endpoints, the site staff regularly takes blood samples.
Conditions Studied
Interventions
- DRUG BI 1584862
Study Locations (3)
Arizona
- Arizona Clinical Trials - Chandler - Chandler
Florida
- Omega Research Orlando, LLC - Orlando
Texas
- American Research Corporation - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2025-08-06 |
| Est. Completion | 2026-06-29 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06957756
The ClinicalTrials.gov registry entry for NCT06957756 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 37-participant average among 14 other Hepatic Insufficiency trials with a reported enrollment target (19% higher). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatic Insufficiency appearing as the primary indexed condition, and to 1 intervention - of which BI 1584862 is the first listed.
NCT06957756 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Arizona, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT06957756 about?
NCT06957756 is a clinical study titled "A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems". This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m2 can take part. This study includes people with mild, moderate, and severe liver problems, and people without liver problems as a matching control. The purpose of this study is to ...
What is the current status of trial NCT06957756?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2025-08-06. Estimated completion is 2026-06-29.
What conditions does trial NCT06957756 study?
This clinical trial studies the following conditions: Hepatic Insufficiency.
What interventions are being tested in trial NCT06957756?
The interventions under investigation include: BI 1584862 (DRUG).
Who is sponsoring clinical trial NCT06957756?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06957756 being conducted?
This trial has 3 study locations across Arizona, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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