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Randomized Phase 3 Study of Deupirfenidone (LYT‑100) versus Pirfenidone in Adults with Idiopathic Pulmonary Fibrosis

Verified siteRegistered drugNo placebo
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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 condition in which scar tissue slowly forms in the lungs, making it harder to breathe and reducing the amount of oxygen that reaches the body. The study compares two oral medicines that are taken by mouth: the experimental drug Deupirfenidone (also called LYT‑100) and the already‑approved drug Pirfenidone. Both are given in capsule or tablet form and are intended to slow the worsening of lung scarring.

The purpose of the study is to find out whether Deupirfenidone can reduce the decline in lung function as well as or better than Pirfenidone. Participants are randomly assigned to receive one of the two medicines, and neither the participants nor the study staff know which one is being taken, ensuring a fair comparison. Each person will take the assigned medication every day for about one year, with regular visits to the clinic for safety checks and health assessments.

During the study, participants will have periodic breathing tests that measure how much air can be exhaled in one effort, known as forced vital capacity. These tests help doctors see if the medicines are helping to keep lung function stable. Additional routine examinations will monitor overall health and any side effects, allowing the research team to evaluate the safety of the treatments over the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    After joining the study, you will undergo initial examinations that include a review of your medical history, a physical exam, and a lung function test called forced vital capacity (fvc).

    These assessments establish a starting point for measuring changes over the course of the trial.

  2. Step 2

    Randomization

    Based on the baseline information, you will be randomly assigned to receive either deupirfenidone or pirfenidone.

    The assignment is done in a way that you and the study staff do not know which medication you receive, ensuring a double‑blind design.

  3. Step 3

    Start of medication

    You will begin taking the medication that was assigned to you.

    If you receive deupirfenidone, the dose is 2475 mg taken orally in capsule form.

    If you receive pirfenidone, the dose is 2403 mg taken orally as a film‑coated tablet.

    The medication is taken as directed by the study protocol, typically once each day.

  4. Step 4

    Regular follow‑up visits

    Throughout the 52‑week period, you will attend scheduled clinic visits to monitor your health.

    At each visit the study team will check your lung function, ask about any side effects, and may perform blood tests or other safety assessments.

    These visits occur at intervals defined by the study schedule, allowing the researchers to track how the medication is working over time.

  5. Step 5

    Safety monitoring

    During the trial you will be monitored for any adverse effects.

    The study team will review laboratory results and ask you to report any new symptoms, adjusting the treatment plan if necessary.

  6. Step 6

    Final assessment at week 52

    At the end of the 52‑week study you will undergo a final set of examinations, including another forced vital capacity test.

    The results will be compared with the baseline measurements to determine the effectiveness and safety of the medication you received.

Who can join the trial?

7 criteria

  • You must be at least 40 years old when you give consent to join the study.
  • You need to have a diagnosis of Idiopathic Pulmonary Fibrosis that follows the 2022 guidelines from major lung societies (American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society).
  • Your diagnosis of Idiopathic Pulmonary Fibrosis must have been made no more than 7 years ago.
  • You must not have taken the medicines pirfenidone or LYT-100 before joining the trial.
  • A recent lung scan called high‑resolution computed tomography (HRCT), done within the past 12 months, must show a pattern called usual interstitial pneumonia (UIP) that is either definite or probable, and this finding must be confirmed by a central reviewer.
  • Your forced vital capacity (FVC) – the amount of air you can exhale forcefully – must be at least 45% of the predicted normal value for someone of your age, sex, and size, measured at the first study visit.
  • If you live in France, you must be either enrolled in or receive benefits from the French social security system.

Who cannot join the trial?

25 criteria

  • Has a noticeable worsening of IPF between the first two study visits, such as a serious hospital stay or a major breathing problem.
  • Has cardiovascular disease (any heart or blood‑vessel condition).
  • Has chronic liver disease or other serious liver problems.
  • Has ongoing infections, including active viral hepatitis (liver virus) or poorly controlled HIV (virus that weakens the immune system).
  • Had a major surgery within 6 weeks before the first visit, or plans to have major surgery during the study.
  • Has a current cancer or a history of cancer within the past 5 years.
  • Shows any of the following lab abnormalities at the first visit:
    • Liver enzymes (AST or ALT) more than 1.5 times the normal upper limit.
    • Total bilirubin more than 1.5 times the normal upper limit (except for mild cases like Gilbert’s syndrome).
    • Kidney function (creatinine clearance) less than 30 mL/min.
    • Is taking prednisone (a steroid medication) at a steady dose higher than 10 mg per day.
    • Has used tobacco or smoked cannabis within 3 months before the first visit, or cannot stay away from them during the trial.
    • Has trouble swallowing pills (dysphagia), difficulty with capsules or tablets, or has had the entire stomach removed (total gastrectomy).
    • Is currently enrolled in another clinical study (except observational studies) or has used any experimental drug or device within 90 days before the first visit.
    • Was hospitalized within 3 months before the first visit for a sudden worsening of IPF or another serious breathing complication.
    • Has ever received stem‑cell therapy for lung fibrosis.
    • Is pregnant, breastfeeding, or planning to become pregnant during the study.
    • Has ever taken LYT‑100 or pirfenidone before, even a single dose.
    • For participants in Germany only: has been placed in a care institution by a court or administrative order.
    • Has a pre‑bronchodilator FEV1/FVC ratio less than 0.7 at the first visit (a lung function measure indicating obstruction).
    • Has more emphysema than fibrosis on the most recent high‑resolution CT scan, as confirmed by the central reading team.
    • Has any other condition that could explain interstitial lung disease (ILD) besides IPF.
    • Has a major health problem outside the lungs that could affect breathing test results (spirometry).
    • Has another significant respiratory disorder.
    • Has significant pulmonary hypertension (high blood pressure in the lungs).
    • Has had a lung transplant.
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Investigated drugs

  • Deupirfenidone

    is an experimental oral medication taken in capsule form. In this study it is being tested as a new treatment for adults with idiopathic pulmonary fibrosis (IPF), a condition that causes scarring of the lungs. Researchers are looking to see if deupirfenidone can slow the loss of lung function compared with the standard therapy. Because it is still under investigation, it is considered an orphan drug, meaning it is being developed for a rare disease.

  • Pirfenidone

    is an approved oral drug that comes as a film‑coated tablet. It is already used to treat IPF by helping to reduce the rate of lung scarring. In this trial it serves as the comparator, allowing scientists to compare the effectiveness and safety of the new drug, deupirfenidone, against an existing standard treatment.

What is already known about the treatment

  • Deupirfenidone (LYT‑100)

    This investigational drug is taken by mouth in capsule form, with a daily dose of 2475 mg. It is currently being studied in Phase 3 trials and has orphan‑drug status, but is not yet approved for general medical use. The medication is intended to treat idiopathic pulmonary fibrosis, a rare lung disease that causes scarring of lung tissue. It works by blocking signals that cause fibroblasts to multiply and produce excess scar tissue, and it is classified as an oral anti‑fibrotic agent.

  • Pirfenidone (Zentiva)

    Pirfenidone is an approved oral medication supplied as film‑coated tablets, usually taken at a total daily dose of about 2400 mg. It is listed in the ATC system under L04AX05 and is widely used for idiopathic pulmonary fibrosis. The drug helps slow lung scarring by reducing the production of collagen and calming inflammatory chemicals in the lungs. It belongs to the class of oral anti‑fibrotic agents (pyridone derivatives).

Investigated diseases

Idiopathic Pulmonary Fibrosis - Idiopathic Pulmonary Fibrosis is a chronic lung disease characterized by the formation of scar tissue (fibrosis) in the lungs without a known cause. The scar tissue makes the lungs stiff, reducing their ability to expand and contract during breathing. Over time, the scarring typically spreads, leading to a gradual decline in lung capacity. People often notice increasing shortness of breath, especially during activity, and a persistent dry cough. The disease usually advances slowly but steadily, affecting daily function as it progresses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524493-42-00Protocol codeLYT-100-2025-301Estimated enrolment1 082 patientsSponsorPuretech Lyt 100 Inc.

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