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Looking for participantsPhase2

A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis

Sponsor: Rein Therapeutics

NCT ID: NCT06968845

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
LTI-03 (drug), Dry Powder Inhaler (device), Placebo (drug)
How long the study runs
Study runs about 22 months (dates as stated)
About the drug or intervention
LTI-03 — drug: Caveolin-1-Scaffolding-Protein-Derived Peptide · Dry Powder Inhaler — device: Plastiape Monodose RS01 Model 7 · Placebo — drug: Lactose powder
Patient visit burden
"Study Assessments: Up to 9 visits to the study clinic will be required." (as stated by sponsor)

In plain English

This is a Phase 2 study testing a medicine called LTI-03 in people with idiopathic pulmonary fibrosis (IPF), a condition where the lungs become scarred and breathing gets harder. Phase 2 means the medicine is being checked in a larger group of people to see how well it works and how safe it is. The study is paid for by Rein Therapeutics.

Who can take part

  • Men or women aged 40 or over.
  • Able to give written permission (consent) to take part.
  • Diagnosed with IPF within the last 5 years, confirmed by a special lung scan read by experts. The scarring must affect at least 10% of the lung and be worse than any emphysema (a different type of lung damage).
  • A breathing test result (forced vital capacity, or FVC — how much air you can breathe out) of at least 45% of the expected level.
  • A lung test showing how well oxygen passes into your blood (DLCO) of at least 30% of the expected level, checked within 8 weeks before joining.
  • If you take nintedanib, pirfenidone or nerandomilast for IPF, you must have been on a steady dose for at least 12 weeks before joining.
  • If you stopped taking any of those IPF medicines, you must have stopped at least 8 weeks before joining.
  • Able to use the study's inhaler device yourself.

Who may not be able to

  • A breathing test result (FEV1/FVC ratio below 0.7) that suggests asthma or a similar airway problem.
  • Taking N-acetyl cysteine or certain supplements (such as quercetin, omega-3 fatty acids, DHEA, polyphenols or plant-based chemicals) within 7 days before joining, and through to week 24.
  • Taking steroid tablets above 10 mg a day of prednisone (or similar) within 28 days before joining.
  • Currently smoking.
  • A sudden worsening of your lung condition within 3 months before joining.
  • A fever and chest illness needing antibiotics within 28 days before joining.
  • Taking part in another clinical study, or having an experimental drug or device, within 28 days before joining (or longer, depending on the drug).
  • Serious kidney problems (a kidney filtering measure called eGFR below 30).
  • Serious liver problems (shown by certain blood test results).
  • Cancer now or within the past 5 years, apart from some early, non-spreading skin cancers, early cervical cancer, or prostate cancer.
  • Another serious medical or mental health problem that could interfere with the study, or an expected survival of less than 24 weeks.
  • A positive pregnancy test if you are a woman who can become pregnant.
  • Breastfeeding.
  • Women who can become pregnant, and men whose partners can become pregnant, must not take part unless they agree to use reliable contraception during the study and for at least 90 days after the last dose. Men must also agree not to donate sperm during this time.

What taking part involves

  • • Taking the study medicine LTI-03 using an inhaler device, which you use yourself.
  • • The study lasts at least 24 weeks (about 6 months), based on details given in the criteria.
  • • You may continue taking your usual IPF medicine (nintedanib, pirfenidone or nerandomilast) if the dose has been stable for at least 12 weeks.

Time commitment: Not stated — ask the trial team about number of visits, tests and overall study length, and what taking part would involve.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
40 Years and over
Who
All
Number of participants
120
Started
2026-02-02
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for idiopathic pulmonary fibrosis (ipf)
  • • Phase2 - 120 participants
  • • Rationale: LTI-03 is an experimental medication breathed into the lungs using an inhaler

Who can take part?

  • • Ages 40 Years and over
  • • Diagnosed with idiopathic pulmonary fibrosis (ipf)

Where?

  • • Birmingham - Birmingham Chest Clinic
  • • Edgbaston - Queen Elizabeth Hospital Birmingham
  • • Trumpington - Royal Papworth Hospital
  • • Exeter - Royal Devon and Exeter Hospital
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Rationale: LTI-03 is an experimental medication breathed into the lungs using an inhaler. It is being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a progressive, fatal lung disease caused by the death of lung cells involved in oxygen uptake and by progressive fibrosis (scarring) of the lungs. As the disease progresses, patients experience loss of lung function and increased breathing problems. LTI-03 is hypothesized to treat IPF by protecting and restoring the function of the oxygen uptake cells and by controlling lung fibrosis which may result in improving lung scarring. The purpose of this research is to evaluate LTI-03 including: its safety, whether it causes side effects, whether it improves lung scarring, and whether it improves IPF symptoms. LTI-03 will be compared to placebo in patients diagnosed with IPF within the last 5 years. Patients on a stable dose of nintedanib, pirfenidone, or nerandomilast (if available by prescription) may participate. Trial Design: This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study that includes a 28-day Screening Period, a 24-week Treatment Period, and 4-week Follow-up Period. Study Assessments: Up to 9 visits to the study clinic will be required. Safety and tolerability will be evaluated with the following assessments: physical examination; collection of vital sign data (heart rate, blood pressure, respiratory rate and peripheral oxygen saturation \[SpO2\] via pulse oximetry); heart data collected by 12-lead electrocardiogram; and collection of blood samples for safety laboratory tests. In addition, participants will be asked about any adverse events (side effects) they have experienced between clinic visits, if they have changed any medications, and if they are able to properly use their study drug inhaler. Participants will undergo a lung function test (spirometry) at every visit, which will be used to evaluate both safety and efficacy. Another test measuring the diffusion capacity of the lungs for carbon monoxide (DLCO) will be required at Screening only. Blood samples will also be collected at each visit to measure disease biomarkers. At select visits patients will be asked to complete the Living with Pulmonary Fibrosis questionnaire to evaluate their IPF symptoms. Participants will also undergo a specialized lung scan (HRCT) at Baseline and at the End of Treatment to measure changes in lung fibrosis. Interventions: LTI-03 and placebo are provided in powder-filled capsules that participants will self- administer using an inhaler. Placebo capsules look like LTI-03 capsules but have no active ingredients. Approximately 120 participants will be randomly assigned in a blinded manner to one of study drug treatment groups.

Idiopathic Pulmonary Fibrosis (IPF)

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

Treatment history

Treatments you must have had:

  • ✓ been on a stable prescribed dose for at least 12 weeks
  • ✓ discontinued treatment at least 8 weeks

What the study is looking for

  • ✓Male or female age 40 years or older.
  • ✓Willing and able to provide written agreement to take part.
  • ✓Forced vital capacity (FVC) percent predicted ≥ 45% at Screening.
  • ✓Diffusion capacity of the lungs for carbon monoxide (DLCO), red blood cell level-corrected percent predicted ≥ 30% within 8...
  • ✓Participants who previously received nintedanib, pirfenidone, or nerandomilast must have discontinued treatment at...

Who cannot take part

  • ✗Forced expiratory volume in 1 second (FEV1)/FVC \< 0.7 at Screening.
  • ✗Use of systemic corticosteroids at doses \> 10 mg/day of prednisone or equivalent within 28 days prior to Randomization.
  • ✗Active smoker.
  • ✗lung exacerbation within 3 months prior to Screening.
  • ✗Febrile lung illness requiring antibiotic treatment within 28 days prior to Randomization.
See the full 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 Is This Study? (7 UK sites)

Birmingham Chest Clinic

Birmingham B91 2JL, United Kingdom

Recruiting
Site contact (verified)
Gareth Walters, MDPrincipal Investigator

Queen Elizabeth Hospital Birmingham

Edgbaston B15 2GW, United Kingdom

Recruiting
Site contact (verified)
David Thickett, MDPrincipal Investigator

Royal Papworth Hospital

Trumpington CB2 0AY, United Kingdom

Recruiting
Site contact (verified)
Helen Parfrey, MDPrincipal Investigator

Royal Devon and Exeter Hospital

Exeter EX2 5DW, United Kingdom

Recruiting
Site contact (verified)
Michael Gibbons, MDPrincipal Investigator

Churchill Hospital

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Peter Saunders, MDPrincipal Investigator

Royal Infirmary of Edinburgh

Edinburgh EH16 4SA, United Kingdom

Recruiting
Site contact (verified)
Manjit Cartlidge, MDPrincipal Investigator

Royal Brompton Hospital

London SW3 6HP, United Kingdom

Recruiting
Site contact (verified)
Philip Molyneaux, MDPrincipal Investigator

How to Get in Touch

Steven A. Shoemaker, MD

Sponsor contact

CONTACT

720-560-2167 sshoemaker@nicosof.com

Shawna H. Evans

Sponsor contact

CONTACT

sevans@reintx.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-03