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New inhaled drug aims to fight deadly lung scarring

NCT ID NCT06968845

Disease control Sponsor: Rein Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 04, 2026 · Updated 14 times

Summary

This Phase 2 trial tests an experimental inhaled medication called LTI-03 in about 120 people with idiopathic pulmonary fibrosis (IPF), a progressive lung disease that causes scarring and breathing difficulty. Participants will inhale LTI-03 or a placebo twice daily for 24 weeks. The study measures safety, lung function, and changes in lung scarring via scans and questionnaires.

What this could mean

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

Active substance
LTI-03 (an experimental inhaled peptide)
What this could lead to
If successful, LTI-03 could offer a new treatment option that protects lung cells and reduces scarring, potentially slowing disease progression in IPF patients.
What could go wrong
This is an early Phase 2 trial with only 120 participants, so results may not confirm benefit. The drug is compared to placebo, and side effects or lack of efficacy are possible.

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 120 people

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

Started

Feb 2026

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. Male or female age 40 years or older. 2. Willing and able to provide written informed consent. 3. Diagnosis of IPF within 5 years of Screening as confirmed by a centrally read HRCT of the chest as defined by the ATS/ERS/JRS/ALAT guideline. HRCT lung fibrosis by central read during screening must involve ≥ 10% of the lung and be greater than emphysema involvement of the lung. 4. Forced vital capacity (FVC) percent predicted ≥ 45% at Screening. 5. Diffusion capacity of the lungs for carbon monoxide (DLCO), hemoglobin-corrected percent predicted ≥ 30% within 8 weeks prior to Randomization. 6. Participants receiving nintedanib, pirfenidone, or nerandomilast (where approved for marketing) for IPF treatment must have been on a stable prescribed dose for at least 12 weeks prior to Randomization. 7. Participants who previously received nintedanib, pirfenidone, or nerandomilast must have discontinued treatment at least 8 weeks prior to Randomization. 8. Able to adequately self-administer study drug using the protocol-specified inhaler device. Exclusion Criteria: 1. Forced expiratory volume in 1 second (FEV1)/FVC \< 0.7 at Screening. 2. Use of N-acetyl cysteine or other supplements including but not limited to quercetin, omega-3 fatty acids, dehydroepiandrosterone, polyphenols, and phytochemicals within 7 days prior to Randomization and through Week 24. 3. Use of systemic corticosteroids at doses \> 10 mg/day of prednisone or equivalent within 28 days prior to Randomization. 4. Active smoker. 5. Pulmonary exacerbation within 3 months prior to Screening. 6. Febrile pulmonary illness requiring antibiotic treatment within 28 days prior to Randomization. 7. Participation in a clinical study or treatment with an investigational drug or device within 28 days of the Screening Visit (or 5 half-lives of the investigational agent, whichever is longer). 8. History or evidence at Screening of significant renal impairment with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2. 9. History or evidence at Screening of significant hepatic impairment with bilirubin \> 3 mg/dL (\> 51.3 μmol/L) and albumin \< 2.8 g/dL (\<28 g/L) and PT prolongation \> 6 sec or INR \> 2.3 while not on anticoagulant medication. 10. Active or history of malignancies within 5 years prior to Randomization, with the exception of localized nonmetastatic basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or prostate cancer. 11. Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol; or an expected survival of less than 24 weeks. Contraception and Pregnancy 12. Positive pregnancy test in female participants of childbearing potential (defined below). 13. Female participants who are lactating. 14. Females of childbearing potential (FOCBP) and men with partners of childbearing potential who do not agree to use an acceptable form of contraception for the duration of study treatment and for at least 90 days after the last dose of study drug. Male participants who do not agree to refrain from donating sperm during this same period.

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis interstitial lung disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis (IPF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    36 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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.

Contacts and locations

Locations

  • Agaplesion Evangelisches Krankenhaus Mittelhessen

    RECRUITING

    Giessen, Hesse, 35398, Germany

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Baylor Scott and White Health

    RECRUITING

    Temple, Texas, 76508, United States

  • Birmingham Chest Clinic

    RECRUITING

    Birmingham, Birmingham, B91 2JL, United Kingdom

  • Box Hill Hospital

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Churchill Hospital

    RECRUITING

    Oxford, Oxfordshire, OX3 7LE, United Kingdom

  • Cleveland Clinic Florida

    RECRUITING

    Weston, Florida, 33331, United States

  • El Paso Pulmonary Association

    RECRUITING

    El Paso, Texas, 79902, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Instytut Gruzlicy i Chrob Pluc

    RECRUITING

    Warsaw, Poland, 01-138, Poland

  • Launceston Respiratory and Sleep Centre

    RECRUITING

    Launceston, Tasmania, 7250, Australia

    Contact Email: •••••@•••••

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medical University of Łódź

    RECRUITING

    Lodz, Łódź Voivodeship, 90-153, Poland

  • National Jewish Health

    RECRUITING

    Denver, Colorado, 80206, United States

  • Paradigm Clinical Research Centers, LLC

    RECRUITING

    San Diego, California, 92108, United States

  • Queen Elizabeth Hospital Birmingham

    RECRUITING

    Edgbaston, Birmingham, B15 2GW, United Kingdom

  • Royal Brompton Hospital

    RECRUITING

    London, SW3 6HP, United Kingdom

  • Royal Devon and Exeter Hospital

    RECRUITING

    Exeter, Devon, EX2 5DW, United Kingdom

  • Royal Infirmary of Edinburgh

    RECRUITING

    Edinburgh, Scotland, EH16 4SA, United Kingdom

  • Royal Papworth Hospital

    RECRUITING

    Trumpington, Cambridge, CB2 0AY, United Kingdom

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Salus Aegroti Praktyka Lekarska dr n. med. Grzegorz Gąsior

    RECRUITING

    Sosnowiec, Silesian Voivodeship, 41-208, Poland

  • The Lung Research Center, LLC

    RECRUITING

    Chesterfield, Missouri, 63017, United States

  • Thoraxklinik-Heidelberg gGmbH Studienzentrum ThoraxKliPS

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • Twoja Przychodnia NCM

    RECRUITING

    Nowa Sól, Lubusz Voivodeship, 67-100, Poland

  • UAB Lung Health Center

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06511, United States

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