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MinorEligibility criteria expanded, about 103 words
Study description expanded, about 23 words
v268
Minor2 versionsRe-verified since Feb 25, 2026, no change to tracked fieldsv266-v267
MinorEligibility criteria shortened, about 7 wordsv265
Minor4 versionsRe-verified since Jul 9, 2025, no change to tracked fieldsv261-v264
Show 41 earlier versionsHide 41 earlier versions
MinorEligibility criteria shortened, about 2 wordsv260
MinorRe-verified, no change to tracked fieldsv259
MinorStart date changed from estimate of May 12, 2025 to May 5, 2025v258
MinorStart date: May 11, 2025 to May 12, 2025v257
MinorStart date: May 8, 2025 to May 11, 2025v256
MinorStart date: May 7, 2025 to May 8, 2025v255
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MinorStart date: May 1, 2025 to May 4, 2025v251
MinorStart date: Apr 30, 2025 to May 1, 2025v250
MinorStart date: Apr 29, 2025 to Apr 30, 2025v249
MinorStart date: Apr 28, 2025 to Apr 29, 2025v248
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MinorStart date: Apr 7, 2025 to Apr 8, 2025v235
MinorStart date: Apr 4, 2025 to Apr 7, 2025v234
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MinorStart date: Mar 31, 2025 to Apr 1, 2025v231
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MinorStart date: Mar 20, 2025 to Mar 23, 2025v224
MinorStart date: Mar 19, 2025 to Mar 20, 2025v223
MinorStart date: Mar 18, 2025 to Mar 19, 2025v222
MinorStart date: Mar 17, 2025 to Mar 18, 2025v221
MinorStart date: Mar 16, 2025 to Mar 17, 2025v220
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background:
Interstitial lung disease affects the tissues that aid the transfer of oxygen and carbon dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening and scarring of lung tissue. Fibrosis often continues getting worse, and most people with this disease die in 3 to 5 years.
Objective:
To test a study drug (hymecromone) in people with interstitial lung disease or lung fibrosis.
Eligibility:
People aged 18 years and older with interstitial lung disease or lung fibrosis.
Design:
Participants will have at least 7 clinic visits over 5 months.
Participants will have screening and baseline visits. They will have blood tests and tests of their heart function. They will give a sputum sample. Other tests will include:
Spirometry: Participants will breathe in and out through a mouthpiece to measure how much air they can hold in their lungs and how hard they can breathe.
Diffusion capacity of lungs for carbon monoxide: Participants will breathe in a gas that contains a small amount of carbon monoxide. Then they will breathe through a mouthpiece. This test measures how well oxygen moves from the air into the blood.
Resting energy expenditure. Participants will lie still for 30 minutes with a clear dome over their head. This test measures the calories their body burns at rest.
6-minute walk test. Participants will walk at their normal pace for 6 minutes. Their vital signs and blood oxygen levels will be checked.
Hymecromone is a tablet taken by mouth. Participants will take 2 tablets every morning and 2 tablets every night for 12 weeks. Participants who decide to continue longer may enter an optional 12 week extension phase, for a maximum treatment time of 24 weeks. Tests will be repeated at study visits.