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NCT07036523 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Idiopathic Pulmonary Fibrosis, sponsored by Boehringer Ingelheim.

Recruiting
Registry status
Phase 2
Development phase
71
Enrollment target
20
Study locations

NCT07036523 is a Phase 2 study of Idiopathic Pulmonary Fibrosis that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 71 participants, below the 750-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT07036523, a Phase 2 study of Idiopathic Pulmonary Fibrosis, is actively recruiting participants, sponsored by Boehringer Ingelheim.

RECRUITING
Registry status
Phase 2
Development phase
71 participants
Enrollment target
20
Study locations

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

Idiopathic Pulmonary Fibrosis

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

FieldValue
Enrollment Target 71 participants
Start Date 2025-11-13
Est. Completion 2027-09-02
Phase Phase 2

Sponsor

Boehringer Ingelheim

515 total trials

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What the Registry Record Tells You About NCT07036523

The ClinicalTrials.gov registry entry for NCT07036523 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 750-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (91% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

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.

NCT07036523 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Florida, Missouri, New York.

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.

What interventions are being tested in trial NCT07036523?

The interventions under investigation include: Placebo (DRUG), BI 765423 (DRUG).

Who is sponsoring clinical trial NCT07036523?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.