A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood

An Open-label, Single-group Trial to Evaluate the Effect of Pirfenidone on the Pharmacokinetics of a Single Oral Dose of BI 1015550

A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood (NCT06241560) is a Phase 2 interventional studying Idiopathic Pulmonary Fibrosis, sponsored by Boehringer Ingelheim. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are 40 years and older. The purpose of this study is to find out whether a medicine called pirfenidone changes the amount of a medicine called BI 1015550 in the blood. Some people may take more than one medicine at a time. Therefore, it is important to understand how different medicines influence one another. Participants take one dose of BI 1015550 as a tablet. Participants then take one tablet of pirfenidone 3 times a day for one week. The dose is then increased to 2 tablets 3 times a day for the second week. In the third week the dose is increased further to 3 tablets 3 times a day. Participants then take another dose of BI 1015550 as a tablet. Participants are in the study for a little over 1 month. During this time, they visit the study site 15 times. Two of the visits include overnight stays at the study site. The study staff also contacts the participants by phone. During the visits, the doctors collect information about participants' health and take blood samples from the participants. They compare the amount of pirfenidone and BI 1015550 in the blood. Doctors also regularly check participants' health and take note of any unwanted effects.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Idiopathic Pulmonary Fibrosis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female patients aged ≥40 years old at the time of signed consent - Patients with idiopathic pulmonary fibrosis (IPF) and an indication/no contraindication for treatment with pirfenidone based on investigator's judgement. - Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive) - Signed and dated written willing to sign a consent form in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial - Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OC) also have to use one barrier method Who Should NOT Join This Trial: - Patients with a significant disease or condition other than IPF, which in the opinion of the investigator, may put the patient at risk because of participation, interfere with study procedures, or cause concern regarding the patient's ability to participate in the study - Acute IPF exacerbation within 1 month prior to Visit 1 and/or during the screening period (investigator-determined). - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 x ULN or total Bilirubin \>1.5 x upper limit of normal (ULN) at Visit 1 - Patients with underlying liver cirrhosis (Child Pugh C hepatic impairment) - Cardiovascular diseases, any of the following: - Severe hypertension (uncontrolled under treatment ≥160/100 mmHg at multiple occasions) within 3 months of Visit 1 - Myocardial infarction, stroke or transient ischemic attack within 6 months of Visit 1 - Unstable cardiac angina within 6 months of Visit 1 - Chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 90 ml/min/1.73 m\^2 at Visit 1/screening (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula or Japanese version of CKD-EPI for Japanese patients) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion criteria: * Male or female patients aged ≥40 years old at the time of signed consent * Patients with idiopathic pulmonary fibrosis (IPF) and an indication/no contraindication for treatment with pirfenidone based on investigator's judgement. * Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive) * Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial * Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OC) also have to use one barrier method Exclusion criteria: * Patients with a significant disease or condition other than IPF, which in the opinion of the investigator, may put the patient at risk because of participation, interfere with study procedures, or cause concern regarding the patient's ability to participate in the study * Acute IPF exacerbation within 1 month prior to Visit 1 and/or during the screening period (investigator-determined). * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 x ULN or total Bilirubin \>1.5 x upper limit of normal (ULN) at Visit 1 * Patients with underlying liver cirrhosis (Child Pugh C hepatic impairment) * Cardiovascular diseases, any of the following: * Severe hypertension (uncontrolled under treatment ≥160/100 mmHg at multiple occasions) within 3 months of Visit 1 * Myocardial infarction, stroke or transient ischemic attack within 6 months of Visit 1 * Unstable cardiac angina within 6 months of Visit 1 * Chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 90 ml/min/1.73 m\^2 at Visit 1/screening (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula or Japanese version of CKD-EPI for Japanese patients) * Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * Relevant chronic or acute infections including but not limited to human immunodeficiency virus (HIV) and viral hepatitis * Further exclusion criteria apply

Treatments Being Tested

DRUG

BI 1015550

DRUG

Pirfenidone

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Renovatio Clinical-The Woodlands-69551

The Woodlands, Texas, United States

LTD The First Medical Center

Tbilisi, Georgia

LTD "Aversi clinic"

Tbilisi, Georgia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06241560), the sponsor (Boehringer Ingelheim), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06241560 clinical trial studying?

Who can participate in NCT06241560?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06241560?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06241560. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06241560. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.