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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

5 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

PIPE-791 - PIPE-791 is taken as an oral tablet that patients swallow with water. It is still an investigational drug, currently being studied in Phase 2 trials and not yet approved for any use. The medication is being tested for idiopathic pulmonary fibrosis, a disease that causes scarring of the lungs. PIPE-791 is thought to work by blocking signals that make lung cells over‑produce scar tissue, placing it in the experimental antifibrotic drug class.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521901-42-00Protocol codeCTX-791-201Estimated enrolment428 patients

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