Can a new daily pill slow lung scarring in IPF?
NCT ID NCT07728721
First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether an experimental drug called HSK50042 can improve lung function in adults with idiopathic pulmonary fibrosis (IPF), a chronic condition that causes lung scarring and breathing difficulties. Participants take HSK50042 or a placebo once daily for 26 weeks. The study measures changes in forced vital capacity (a key lung function test) at 12 and 26 weeks to see if the drug slows disease progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental drug called HSK50042 taken orally once daily
- What this could lead to
- If successful, this could point toward a new treatment option for idiopathic pulmonary fibrosis, potentially slowing lung function decline.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not confirm effectiveness. The drug may cause side effects or fail to improve lung function.
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
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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 175 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
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\. Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) prior to screening, patients must meet both of the following criteria: 1. IPF based on 2022 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest HRCT scan taken before or during screening period and if available surgical lung biopsy. 2. Usual interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by the investigator prior to screening. if indeterminate HRCT finding IPF may be confirmed locally by (historical) biopsy. 2\. Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 3. Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin \[Hb\]) ≥ 25% and\<90% of predicted normal at screening period. 4\. Patients have to be either: 1. not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period, and not planning to start or restart anti fibrotic therapy. 2. on stable therapy with nintedanib or pirfenidone or nerandomilast for at least 12 weeks prior to screening and during the screening period. Exclusion Criteria: 1. Clinically significant airways obstruction (Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) \< 0.7) at screening. 2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities. 3. Acute IPF exacerbation within 3 months prior to screening and/or during the screening period (investigator-determined). 4. History of persistent or active micturition/defecation syncope, known prior history of syncope, or concomitant other diseases increasing the risk of syncope (e.g., symptomatic bradycardia, second- or third-degree atrioventricular block, symptomatic valvular heart disease, etc.). 5. Major surgery (major according to the investigator's assessment) performed within 3 months prior to screening or planned during the course of the trial. (Being on a transplant list is allowed). 6. Uncontrolled hypertension at screening or prior to randomization/investigational product administration (defined as refractory hypertension as assessed by the investigator, systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg); or hypotension (seated systolic blood pressure \<100 mmHg or diastolic blood pressure \<60 mmHg). 7. Administration of systemic corticosteroids equivalent to \>15 mg prednisone per day within 4 weeks prior to screening and/or during the screening period.
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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