Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 100

Testing hymecromone in adults with interstitial lung disease

Official title: Phase IIa Investigation of H01 in Adults With Interstitial Lung Disease (The SOLIS Study)

Run by National Institutes of Health Clinical Center (CC) · NCT06325696 · Data updated 2026-11-12

This study is testing a new medication called hymecromone to see if it can help adults with progressive interstitial lung disease feel better and improve their lung function.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 100 Years
SexAll
Enrollment37 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations1 site (Research Triangle Park, North Carolina)
StatusRecruiting
StartedMay 5, 2025
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedJuly 28, 2026
Trial IDNCT06325696 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years old diagnosed with idiopathic pulmonary fibrosis or other forms of progressive interstitial lung disease.

Probably not a fit

Patients with severe lung impairment or those who do not meet the specific inclusion criteria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2a open-label study aims to evaluate the safety, tolerability, and efficacy of hymecromone in adults diagnosed with progressive interstitial lung disease. Up to 37 participants will undergo a series of assessments over five months, including blood tests, lung function tests, and sputum samples. The primary objective is to measure the reduction of hyaluronan levels in participants, while secondary objectives include assessing clinical and functional changes, safety, and pharmacokinetics of the drug.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that may slow the progression of interstitial lung disease and improve patients' quality of life.

How similar studies have gone: While this approach is novel, similar studies targeting hyaluronan levels in lung diseases have shown promise, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

* Ability of subject to understand, and the willingness to sign a written informed consent document and comply with requirements of the study
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or Female participants ages \>18 years
* MD diagnosis of Idiopathic Pulmonary Fibrosis or other progressive ILD as defined previously
* DLCO\>30% and FVC\>45%
* Subjects in reproductive age who are heterosexually active must use an acceptable method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, IUD, or Hormone-based contraceptive
* Agreement to adhere to Lifestyle Considerations throughout study duration

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

* Active on lung transplantation list
* On supplemental oxygen at rest
* Evidence of an acute respiratory infection or exacerbation of pulmonary fibrosis
* Known diagnosis of celiac disease or wheat or gluten allergies
* Cirrhosis or active viral or non-viral hepatitis: Bilirubin, AST and ALT values higher than twice the upper range of normal, or a Child-Pugh score of 7 or more
* Subjects with history of active Inflammatory Bowel Disease, dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills
* Subjects with significant renal impairment defined as eGFR lower than 40 ml/min.
* Subjects with a baseline corrected Fridericia's QT interval (QTcF) \>450ms or baseline ECG abnormalities which, in the opinion of the study physician, are clinically significant and would place the participant at increased risk for adverse effects.
* Subjects with ongoing alcohol or illegal drug use disorder
* Subjects who are pregnant, lactating or attempting to conceive

  * Participants able to become pregnant (have not completed menopause, had a hysterectomy and/or both tubes and/or both ovaries removed) must use effective birth control methods to try and not become pregnant while participant in this study. Methods include (a) partner vasectomy, (b) bilateral tubal ligation, (c) intrauterine devices (IUDs), (d) hormonal implants (such as Implanon), or (e) other hormonal methods (birth control pills, injections, patches, vaginal rings).
  * Male participants able to father children with a partner able to become pregnant must agree to use effective birth control (listed above) to participate in this study.
* Known allergy to hymecromone or any component thereof
* Chronic therapy with medications that are known potent human UDP-glucuronosyltransferase inhibitors: canagliflozin, temazepam, tacrolimus.
* Physician concern that participant may not adhere to the study protocol
* Current participation in another clinical treatment trial for ILD. May participate after 12 weeks from conclusion of another treatment trial.
* Changing dose of other ILD medications over the 3 months prior to baseline
* Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that place the participant at increased risk for adverse effects, as determined by the study physician.

Participants who completed the original 12-week treatment portion of the SOLIS study prior to the implementation of the optional 12-week extension phase may have the option to re-enroll under the amended protocol, after an appropriate washout period of up to 6 months. Participants will be re-screened as per criteria above to ensure that eligibility criteria continue to be met. Once eligibility is confirmed, participants can complete the 12-week treatment and optional 12-week extension for a maximum treatment period of 24 weeks. These re-enrolled participants will be enrolled as new participants and receive a different screening number to differentiate them from the original enrollment.

Where it's running

  • NIEHS Clinical Research Unit (CRU)
    Research Triangle Park, North Carolina, United States
    Recruiting

Study contacts

  • Principal investigator: Stavros Garantziotis, M.D. — National Institute of Environmental Health Sciences (NIEHS)
  • Study coordinator: NIEHS Join A Study Recruitment Group
  • Email: myniehs@nih.gov
  • Phone: (855) 696-4347

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Understanding genetic and environmental factors in pulmonary fibrosis

    This study looks at how genes and environmental factors affect pulmonary fibrosis to help understand the disease better for people who have it.

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  • Beetroot Juice for IPF Patients: A Pilot Test of Nitrate-Rich Supplementation

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    Recruiting University Hospital Southampton NHS Foundation Trust · Southampton · NCT06488638

  • Biobank for interstitial lung diseases

    This study is setting up a collection of health information and samples from patients with interstitial lung diseases to help researchers learn more about the condition and find better treatments.

    Recruiting University of Kansas Medical Center · Kansas City, Kansas · NCT05392881

  • Registry for individuals affected by pulmonary fibrosis

    This study invites people with pulmonary fibrosis, along with their caregivers and family members, to share their experiences through online surveys to help researchers understand the condition better and possibly reach out for future studies.

    Recruiting Pulmonary Fibrosis Foundation · Chicago, Illinois · NCT05382572

  • Examining muscle function in patients with interstitial lung disease

    This study tests how muscle function affects breathing and exercise in people with interstitial lung disease compared to healthy individuals, and looks at how supplemental oxygen might help.

    Recruiting University of British Columbia · Vancouver, British Columbia · NCT03800017

  • New IPF drug ORJ-001 tested in adults with IPF

    A phase 2 study tests ORJ-001 versus placebo in adults with idiopathic pulmonary fibrosis to see if it is tolerated and whether it helps lung function.

    Recruiting at 2 sites Phase 2 Oorja Bio, Inc. · Doral, Florida and 1 other locations · NCT07869147

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.