New pill aims to slow lung scarring in IPF patients
NCT ID NCT07600021
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental tablet called SYH2059 in 156 adults with idiopathic pulmonary fibrosis (IPF), a disease that scars the lungs and makes breathing harder. Participants will receive either the drug or a placebo to see if it can slow the decline in lung function. The goal is to find a safe and effective treatment to control the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 156 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Age ≥ 40 years, regardless of gender; * 2\. The investigator confirms the clinical diagnosis of IPF in participants based on chest HRCT, surgical lung biopsy, or transbronchial lung cryobiopsy (if available) performed during the screening period or within 1 year prior to screening (see Appendix 13.7 for details); * 3\. FVCpp ≥ 45% during the screening period; * 4\. Hemoglobin-corrected DLCOpp ≥ 25% and \< 90% during the screening period; * 5\. Received a single stable-dose antifibrotic therapy for at least 12 weeks prior to screening (concurrent use of nintedanib and pirfenidone is prohibited) and will continue after randomization; or had not received stable antifibrotic therapy, or had discontinued such therapy for at least 8 weeks, with no plan to initiate antifibrotic therapy during the trial; * 6\. Understands the purpose and risks of this study, comprehends and agrees to comply with all study procedures, consents to participate, and provides written informed consent. Exclusion Criteria: * 1\. Interstitial lung disease other than IPF. * 2\. Airway obstruction during screening (FEV₁/FVC \< 0.7), or emphysema greater than pulmonary fibrosis on HRCT. * 3\. Confirmed or suspected acute exacerbation of IPF within 3 months prior to screening. * 4\. Investigator judgment that IPF severity showed sustained improvement during the 12 months prior to screening, based on changes in FVC, DLCO and/or HRCT findings. * 5\. Other clinically significant respiratory diseases during screening. * 6\. Severe diseases in any other system (cardiovascular, digestive, neurological, hematological, endocrine) during screening. * 7\. Malignancy within 5 years prior to screening (excluding treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin, or carcinoma in situ of the cervix). * 8\. Any acute infection within 2 weeks prior to screening that has not fully recovered per investigator judgment. * 9\. Active, unstable or uncontrolled vasculitis within 8 weeks prior to screening. * 10\. Any acute or chronic active infection during screening. * 11\. C-SSRS assessment during screening indicating suicidal behavior within the past 2 years (actual attempt, interrupted attempt, aborted attempt, or preparatory acts or gestures), or clinically significant suicidal ideation within 3 months prior to screening or during screening (participant answered "yes" to C-SSRS suicidal ideation question 4 or 5). * 12\. Treatment with PDE1, PDE3, PDE4, PDE10 inhibitors, or non-selective PDE inhibitors within 4 weeks prior to screening. * 13\. Use of strong CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of investigational product, or inability to discontinue such agents during the study. * 14\. Receiving immunomodulatory agents (excluding oral glucocorticoids) for respiratory or pulmonary conditions during screening, or prednisone (or equivalent) at a daily dose \> 15 mg. * 15\. Abnormal hepatic and renal function during screening: ALT, AST \> 2.5 × ULN, or TBIL \> 1.5 × ULN, or eGFR \< 30 mL/min/1.73 m². * 16\. Severe, persistent, uncontrolled hypertension during screening (SBP ≥ 180 mmHg or DBP ≥ 100 mmHg). * 17\. History of smoking within 3 months prior to screening or unwillingness to abstain from smoking (including e-cigarettes) during the study. * 18\. Hypersensitivity to SYH2059 or any excipients, or history of severe drug allergy. * 19\. Participation in any clinical trial within 4 weeks prior to screening (excluding those not receiving investigational product). * 20\. Participation in a clinical study of the same target drug and receipt of treatment within 3 months prior to screening. * 21\. Pregnant or lactating females; fertile females or males unwilling to practice strict contraception throughout the trial and for 3 months after trial completion until the end of the safety follow-up period (including male participants). Any other conditions deemed inappropriate for trial participation by the investigator. * 22\. Additional Exclusion Criteria (for PK intensive sampling participants): * 23\. Previous history of gastrointestinal surgery that may interfere with the PK of the investigational product. * 24\. Alcohol consumption exceeding 14 units per week within 4 weeks prior to screening. * 25\. Habitual excessive intake of xanthine- or caffeine-containing foods, beverages, or other substances affecting drug absorption, distribution, metabolism or excretion within 4 weeks prior to screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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