Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT07036523 · View on ClinicalTrials.gov ↗
Study Summary
This study is open to adults who are at least 40 years old and have idiopathic pulmonary fibrosis (IPF). People can participate in the study if they have a forced vital capacity (FVC) greater than or equal to 45% of the predicted value and fibrosis of 20% or more confirmed by a high-resolution computed tomography (HRCT) scan. The purpose of this study is to find out if a medicine called BI 765423 can improve lung function in people with IPF. The study will compare BI 765423 with a placebo to see if there is a difference in lung capacity after 3 months of treatment and will also look at changes in certain markers related to lung health. Participants are put into two groups randomly, which means by chance. One group receives the study medicine, and the other group receives a placebo. Placebo looks like BI 765423 but does not contain any study medicine. The study medicine is given as an infusion into a vein every four weeks. Participants are in the study for 8-10 months. During the study, participants may continue their regular treatment for IPF. During the study they visit the study site several times for screening, treatment, and follow-up. Doctors regularly test lung function by measuring FVC and take blood samples to measure study endpoints. The results are compared between the two groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BI 765423
Study Locations (20)
Florida
- University of Florida — Gainesville
- Renstar Medical Research — Ocala
Missouri
- The Lung Research Center, LLC — Chesterfield
- University of Missouri Health System — Columbia
New York
- Columbia University Medical Center-New York Presbyterian Hospital — New York
- Weill Cornell Medical College — New York
Alabama
- University of Alabama at Birmingham — Birmingham
Arizona
- Banner - University Medical Center Tucson — Tucson
Iowa
- University of Iowa Hospitals and Clinics — Iowa City
Kansas
- University of Kansas Medical Center — Kansas City
Massachusetts
- Massachusetts General Hospital — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2025-11-13 |
| Est. Completion | 2027-09-02 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07036523
The ClinicalTrials.gov registry entry for NCT07036523 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07036523 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Florida, Missouri, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07036523 about?
NCT07036523 is a clinical study titled "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". This study is open to adults who are at least 40 years old and have idiopathic pulmonary fibrosis (IPF). People can participate in the study if they have a forced vital capacity (FVC) greater than or equal to 45% of the predicted value and fibrosis of 20% or more confirmed by a high-resolution compu...
What is the current status of trial NCT07036523?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2025-11-13. Estimated completion is 2027-09-02.
What conditions does trial NCT07036523 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07036523?
The interventions under investigation include: Placebo (DRUG), BI 765423 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07036523?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07036523 being conducted?
This trial has 20 study locations across Alabama, Arizona, Florida, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.