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New pill aims to slow lung scarring in IPF patients

NCT ID NCT07600021

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 156 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

40 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. 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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  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.