Efficacy and Safety of Oral PIPE-791 in Adults with Idiopathic Pulmonary Fibrosis: A Phase 2 Randomized, Double‑Blind, Placebo‑Controlled Study

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What is this study about?

Idiopathic Pulmonary Fibrosis is a rare lung condition in which scar tissue slowly builds up in the lungs, making it harder to breathe over time. The study is testing an oral tablet called PIPE-791 and comparing it with a placebo to see if the medicine can slow the loss of lung function.

The purpose of the study is to find out whether PIPE-791 can preserve breathing ability better than the placebo. Participants will take the study medication or placebo every day for about six months, with regular visits to check health, report any side effects, and undergo simple breathing tests. One of the key breathing tests measures forced vital capacity (FVC), which is the amount of air a person can push out of the lungs after taking a deep breath; this helps doctors see how the lungs are working. At selected visits, a special detailed X‑ray scan called HRCT will be used to look at the amount of scarring in the lungs. The study follows participants for the full treatment period to monitor safety and how well the drug works.

1 enrollment and consent

you are invited to join the study and asked to read and sign a consent form after the study procedures are explained in plain language.

2 baseline assessments

initial measurements are taken, including a lung function test called forced vital capacity (fvc) that measures how much air you can exhale.

your medical history and current health status are recorded.

3 randomization and receipt of study medication

you are randomly assigned to receive either the active drug pipe-791 or a matching placebo tablet.

the tablets are identical in appearance, and you will not know which one you receive.

4 starting study medication

you begin taking the study tablet by mouth.

each tablet contains 000 mg of the assigned substance.

the exact schedule for taking the tablet (for example, once daily) is provided by the study staff and must be followed for the duration of the trial.

5 ongoing safety monitoring

throughout the study you are asked to report any new symptoms or side effects, referred to as treatment emergent adverse events (teae).

regular phone calls or visits may be arranged to check your well‑being.

6 week 12 visit

you return to the clinic approximately 12 weeks after starting the medication.

the same lung function test (fvc) is repeated and any side effects are reviewed.

7 week 26 visit and final assessment

approximately 26 weeks after starting the medication you attend the final study visit.

a final fvc measurement is performed, the study medication is stopped, and all study data are collected.

the overall effectiveness and safety of the treatment are evaluated at this time.

8 study completion

after the week 26 visit you complete any remaining paperwork and receive information about the overall study results when they become available.

Who Can Join the Study?

  • Be a man or woman who is at least 40 years old when you are randomly assigned to a treatment group.
  • Have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) that was made no more than 7 years before the screening visit, confirmed by the study doctor using current guidelines, and have a chest scan called HRCT that shows a pattern known as usual interstitial pneumonia (UIP) or probable UIP. (IPF is a lung disease that causes scarring; HRCT is a detailed X‑ray of the lungs; UIP is the typical appearance of that scarring on the scan.)
  • Show a percent predicted forced vital capacity (FVC) of 40 % or higher on the screening breathing test. (FVC measures the amount of air you can exhale forcefully after a deep breath; “percent predicted” compares your result to what is expected for someone of your age, sex, and size.)
  • Be allowed to continue taking either the medicine nintedanib or the medicine pirfenidone for IPF, but not both at the same time. (These are approved drugs that help slow the progression of IPF.)

Who Cannot Join the Study?

  • Having any lung disease that causes scarring (called interstitial lung disease (ILD)) other than IPF means you cannot join the study.
  • If you have high blood pressure in the lungs (pulmonary arterial hypertension (PAH)) that needs more than one medication, you are not eligible.
  • Experiencing a sudden worsening of IPF (IPF exacerbation) within 6 weeks before the screening visit or during the screening visit excludes you.
  • Having kidney function measured by an estimated glomerular filtration rate (eGFR) of 30 ml/min/1.73 m² or lower, or having moderate to severe liver disease (Child‑Pugh Class B or C hepatic impairment), means you cannot participate.
  • Female participants who could become pregnant (childbearing potential) are not allowed to join the trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
GWT-Tud GmbH Coswig Germany
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH Essen Germany
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hopital Beaujon Clichy France
CIMS Studienzentrum Bamberg GmbH Bamberg Germany
Romed Klinikum Rosenheim Rosenheim Germany
Pneumologisches Studienzentrum München-West Munich Germany
Cinayqmte Urlbfllpmuycsi Shijtvgcx Woluwe-Saint-Lambert Belgium
Lmhhp Guakvwi Hlacwzpz Ob Aadrlk Athens Greece
Uioisazljd Gwvcaof Hycebqxi Od Impqpdjt Ioannina Greece
Aswiymkwts Pmtnipyl Hpgkmgtp De Mfgdqpxzs Marseille France
Sycxpplrjrvl Hgbtmdolr Gnnl Heilbronn Germany
Gjiyevs Uklzpxoiyq Hlhbsfml Oj Pqwwrw Patras Greece
Jzwszsxteviarueerwlqyppbmg Gmiqrul Giessen Germany
Uurrxikffm Gazjtiy Hryusdva Of Atthmqarhlygsf Alexandroupoli Greece
Cozffy Htqnrqorkqt Umlwjxuseycke Abjooa Pyjqioyq Amiens France
Cnatfj Hwsidctvewm Umdfhmedihqeh Dy Rspekf Rennes France
Cfclga Huwwkbuslpe Lqwj Sbj Pierre Benite France
Ckgyrc Heijxbjinau Riyqefrx Dtrzzsdxqukobx Angers France
Gxlwsl Nkwycplxkf Tngpcfbonbvuh Gccblv Pobztnlthveu Thessaloniki Greece
Cyrqbq Hehlsmfwvis Uhnmmqmcahzip Dtgjgj Gweeqno Szaudbsqdwwqwmuqgwizzszakr Namur Belgium
Uykjqpyuci Geauywb Hmmgiwuc Oh Hqlapfial Heraklion Greece
Iqc Ptyditbcban Gftt &luzi Coz Kk Frankfurt Germany
Umahlvbepu Gsnwmhp Hrkgsmqr Asqukty Gxqkbzs Hmyncbje Ok Wesl Afdlio H Ayzq Vcryomk Chaidari Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
15.09.2026
France France
Not yet recruiting
15.09.2026
Germany Germany
Not yet recruiting
15.09.2026
Greece Greece
Not yet recruiting
15.09.2026

Trial locations

PIPE-791 is an experimental oral tablet being studied as a potential treatment for idiopathic pulmonary fibrosis, a lung disease that causes scarring and makes breathing difficult. In this trial, participants take the tablet by mouth, and researchers compare how well it works to improve lung function, measured by changes in forced vital capacity, against a placebo. The study aims to see if PIPE-791 can safely and effectively slow the progression of the disease and improve patients’ breathing ability.

Investigated Diseases:

Idiopathic Pulmonary Fibrosis (IPF) – Idiopathic Pulmonary Fibrosis is a chronic lung disease in which scar tissue forms in the lungs for unknown reasons. The scarring makes the lung tissue stiff, reducing its ability to expand during breathing. Over time the scar tissue spreads, causing a gradual loss of lung capacity. Patients may notice increasing shortness of breath, especially during activity. The disease usually progresses slowly but can accelerate, leading to greater difficulty breathing as the lungs become more fibrotic.

Trial ID:
2025-521901-42-00
Protocol code:
CTX-791-201
NCT ID:
NCT07284459
Trial Phase:
Therapeutic exploratory (Phase II)

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