Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New pill aims to slow lung scarring in IPF patients

NCT ID NCT06764862

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tested an experimental tablet called HSK44459 in 186 adults with idiopathic pulmonary fibrosis (IPF), a progressive lung-scarring disease. Participants took one of three doses of the drug or a placebo twice daily for 12 weeks. The main goal was to see if the drug could improve or preserve lung function, measured by forced vital capacity (FVC).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HSK44459
What this could lead to
If successful, this could point toward a new oral treatment to slow lung function decline in people with idiopathic pulmonary fibrosis.
What could go wrong
This is a mid-stage trial with only 186 participants over 12 weeks, so results may not confirm long-term benefit or safety. The drug may not improve lung function more than placebo.

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

186 people

The number who actually took part.

Started

Jan 2025

Finished

Mar 2026

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\. 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% 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 for at least 8 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 4 months prior to screening and/or during the screening period (investigator-determined). 4. Lower respiratory tract infection requiring antibiotics within 2 weeks prior to screening and/or during the screening period. 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. History of malignancy within 5 years prior to screening. 7. Any suicidal behavior within 2 years prior to screening (i.e. actual attempts, interrupted attempts, abandoned attempts, or prepared actions or attitudes).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Idiopathic pulmonary fibrosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Contacts and locations

Locations

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100000, China

More trials for these conditions

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