Home › Trials › NCT06968845

Testing LTI-03 for treating Idiopathic Pulmonary Fibrosis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Efficacy of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Patients With Idiopathic Pulmonary Fibrosis

Phase 2 Interventional Rein Therapeutics · NCT06968845

This study is testing a new inhaler medication called LTI-03 to see if it can help people with Idiopathic Pulmonary Fibrosis breathe better and reduce lung damage.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment120 (estimated)
Ages40 Years and up
SexAll
SponsorRein Therapeutics Industry-sponsored
Drugs / interventionsprednisone
Locations11 sites (Birmingham, Alabama and 10 other locations)
Trial IDNCT06968845 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of LTI-03, an experimental medication administered via inhaler, for patients with Idiopathic Pulmonary Fibrosis (IPF). The study aims to determine if LTI-03 can improve lung function and reduce lung scarring compared to a placebo. Participants must have been diagnosed with IPF within the last five years and may continue stable treatment with certain existing medications. The trial will assess both the side effects of LTI-03 and its potential benefits in alleviating symptoms of IPF.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older diagnosed with IPF within the last five years.

Not a fit: Patients with advanced IPF or those who have not been stable on prescribed treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients with IPF.

How similar studies have performed: Other studies have shown promise with antifibrotic treatments for IPF, but the specific approach of LTI-03 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Idiopathic Pulmonary FibrosisAntifibroticInterstitial Lung Disease
Last reviewed 2026-06-13 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.