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A Study of BI 765423 for Idiopathic Pulmonary Fibrosis (IPF)

This study is looking for adults aged 40 or older with idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring. The main goal is to see if a medicine called BI 765423 can improve lung function, specifically your forced vital capacity (FVC), which is how much air you can exhale after a deep breath. You can join if your FVC is at least 45% of what's expected and you have at least 20% fibrosis (scarring) in your lungs, confirmed by a special CT scan. Participants will be randomly assigned to receive either BI 765423 or a placebo (an inactive substance) for 12 weeks. Researchers will then compare changes in lung capacity between the two groups.

Study design
This is an interventional study with an estimated 71 participants. You would be randomly assigned to one of two groups: one receiving BI 765423 and the other receiving a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 weeks, which suggests the main treatment period or observation for this specific outcome is 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07036523

A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment

Recruiting
PHASE2Ages 40+InterventionalTreatment
Boehringer Ingelheim
~71 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:BI 765423Placebo

At a glance

Recruiting sites
20 of 46 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Absolute change from baseline in FVC (mL) at 12 weeks
Measured over Baseline, 12 weeks

Conditions

Idiopathic Pulmonary Fibrosis

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Idiopathic Pulmonary Fibrosis

NCT07036523

Where you'd take part

This study runs at 46 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • A. O. Universitaria Careggi

    Florence, Italystudy coordinator listed

    Recruiting

  • ASST Papa Giovanni XXIII

    Bergamo, Italystudy coordinator listed

    Recruiting

  • Azienda Ospedaliera dei Colli

    Naples, Italystudy coordinator listed

    Recruiting

  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

    Torino, Italystudy coordinator listed

    Recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels, Belgiumstudy coordinator listed

    Recruiting

  • Duke University Medical Center

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Italystudy coordinator listed

    Recruiting

  • Hamamatsu University Hospital

    Shizuoka, Hamamatsu, Japanstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
Email the study team

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Eligibility criteria

Inclusion

Permanently surgically sterilised (hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy)
Postmenopausal, defined as no menses for 12 months without an alternative medical cause. In questionable cases wherein the menopausal status is uncertain and cannot be clearly determined, the following should be taken into consideration by the investigator:
Women not using sex hormone medication such as hormone replacement therapy may be included if a blood sample confirms levels of follicle stimulating hormone (FSH) \> 40 U/L and estradiol \< 30 ng/L" 4. Patients with a documented diagnosis of IPF prior to Visit 1, confirmed by the investigator as per the 2022 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) Guideline and, if available, surgical lung biopsy or transbronchial lung cryobiopsy histopathology report. 5. Patients with a high-resolution computed tomography (HRCT) taken within 12 months of Visit 1 (or during the screening period, if not available) confirming "UIP" or "probable UIP" HRCT pattern consistent with the clinical diagnosis of IPF by central review (prior to Visit 2).
Patients with an "indeterminate" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed based on an historical histopathology report of a surgical lung biopsy or cryobiopsy demonstrating a "UIP" or "Probable UIP" pattern or Multidisciplinary Discussion and Diagnosis as per ATS guidelines.
Patients with an "alternative diagnosis" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed based on an historical histopathology report of a surgical lung biopsy or cryobiopsy demonstrating a "UIP" pattern Multidisciplinary Discussion and Diagnosis as per ATS guidelines. 6. Patients with an extent of fibrosis ≥20% as per an HRCT of the chest performed within 12 months prior to Visit 1 or during the screening period (if not available) and confirmed by central review. 7. Patients with a Forced vital capacity (FVC) ≥45% predicted at Visit 1. Predicted normal values will be calculated according to Global Lung Initiative (GLI). 8. Patients with haemoglobin-corrected diffusing capacity of the lungs for carbon monoxide (DLCO) ≥20% predicted at Visit 1.

Exclusion

Previous clinical or echocardiographic evidence of significant right heart failure according to investigator's judgement
History of right heart catheterisation showing a cardiac index ≤2 L/min/m\^²
PH requiring parenteral therapy with prostanoids 5. On nintedanib or pirfenidone treatment for less than 12 weeks prior Visit 1, planning to start nintedanib or pirfenidone within the first 12 weeks of investigational medicinal product (IMP) treatment or on combined nintedanib plus pirfenidone treatment. Newly diagnosed patients considered in need of SoC treatment during the next 12 weeks by the treating physician, who would be withheld SoC treatment only for the sake of participation in the trial, should also be excluded. 6. Cardiovascular comorbidities including
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 7. Life expectancy for any concomitant disease other than IPF \<2.5 years (investigator assessment).

What this trial measures

  • Absolute change from baseline in FVC (mL) at 12 weeksBaseline, 12 weeks