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Idiopathic Pulmonary Fibrosis (IPF)Phase 2NCT06968845

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

A Phase 2 study testing LTI-03 and Dry Powder Inhaler in people with Idiopathic Pulmonary Fibrosis (IPF), run by Rein Therapeutics at 48 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis (IPF)
What is being tested?
LTI-03 and Dry Powder Inhaler
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
48 sitesin 7 countries
Study dates
2 Feb 2026to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female age 40 years or older.
  • Willing and able to provide written informed consent.
  • 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.
  • Forced vital capacity (FVC) percent predicted ≥ 45% at Screening.
  • Diffusion capacity of the lungs for carbon monoxide (DLCO), hemoglobin-corrected percent predicted ≥ 30% within 8 weeks prior to Randomization.
  • 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.
  • Participants who previously received nintedanib, pirfenidone, or nerandomilast must have discontinued treatment at least 8 weeks prior to Randomization.
  • Able to adequately self-administer study drug using the protocol-specified inhaler device.

Who cannot join

  • Forced expiratory volume in 1 second (FEV1)/FVC < 0.7 at Screening.
  • 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.
  • Use of systemic corticosteroids at doses > 10 mg/day of prednisone or equivalent within 28 days prior to Randomization.
  • Active smoker.
  • Pulmonary exacerbation within 3 months prior to Screening.
  • Febrile pulmonary illness requiring antibiotic treatment within 28 days prior to Randomization.
Show all 15Show fewer
  • 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).
  • History or evidence at Screening of significant renal impairment with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2.
  • 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.
  • 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.
  • 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
  • Positive pregnancy test in female participants of childbearing potential (defined below).
  • Female participants who are lactating.
  • 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.

Trial locations and contacts

48 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Steven A. Shoemaker, MD contact

720-560-2167

sshoemaker@nicosof.com

Shawna H. Evans contact

sevans@reintx.com

48 sites in 7 countries

United States20 sites, 20 recruiting

  • UAB Lung Health Center

    Birmingham, Alabama, 35233

    Andrea Ford, afcook@uabmc.edu

    Tejaswini Kulkarni, MD

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

    Adam Souter, adam_souter@med.unc.edu

    Jason Lobo, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Sarah Grace Purvis, purvissa@musc.edu

    Timothy Whelan, MD

    Recruiting

  • The Lung Research Center, LLC

    Chesterfield, Missouri, 63017

    Anna Shipp, anna.shipp@stlukes-stl.com

    Neil Ettinger, MD

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

    Alayna Gruesbeck, gruesbaj@ucmail.uc.edu

    Nishant Gupta, MD

    Recruiting

  • National Jewish Health

    Denver, Colorado, 80206

    Jane Baer, Baerj@njhealth.org

    Evans Fernandez Perez, MD

    Recruiting

  • Henry Ford Health

    Detroit, Michigan, 48202

    Deepti Naidu, Dnaidu1@hfhs.org

    Asif M. Abdul Hameed, MD

    Recruiting

  • El Paso Pulmonary Association

    El Paso, Texas, 79902

    Karina Espino, karina.espino@elligodirect.com

    Carlo M. Hatem, MD

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Valentina Medina-Roman, Valentina.medina-roman@bcm.edu

    Ivan Rosas, MD

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Erin Sartoris, esartoris@iuhealth.org

    Ryan Boente, MD

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Janell Reichuber, 913-588-2473, jcarlgren@kumc.edu

    Mark Hamblin, MD

    Recruiting

  • University of Southern California

    Los Angeles, California, 90033

    Kathy Sanchez, kathy.sanchez@med.usc.edu

    Toby Maher, MD

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Fatima Contreras, Fatima.contreras@cshs.org

    Tanzira Zaman, MD

    Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut, 06511

    Maksym Minasyan, maksym.minasyan@yale.edu

    Danielle Antin-Ozerkis, MD

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Olia Ali, olia.ali@mssm.edu

    Maria Padilla, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84108

    Jean Verdaguer, jean.verdaguer@hsc.utah.edu

    Mary Beth Scholand, MD

    Recruiting

  • Paradigm Clinical Research Centers, LLC

    San Diego, California, 92108

    Cheryl Bolovits, cbolovits@paradigm-research.com

    Schafer Boeder, MD

    Recruiting

  • Baylor Scott and White Health

    Temple, Texas, 76508

    Vanessa George, Vanessa.George@BSWHealth.org

    Yolanda Mageto, MD

    Recruiting

  • Cleveland Clinic Florida

    Weston, Florida, 33331

    Osvaldo Perez, PEREZO4@ccf.org

    David Zisman, MD

    Recruiting

  • Atrium Health Wake Forest School of Medicine

    Winston-Salem, North Carolina, 27157

    Isaac Deaton, Isaac.deaton@advocatehealth.org

    Heather Clark, MD

    Recruiting

Other trials in United States

United Kingdom8 sites, 8 recruiting

  • Birmingham Chest Clinic

    Birmingham, Birmingham, B91 2JL

    Louise Wood, louise.wood2@uhb.nhs.uk

    Gareth Walters, MD

    Recruiting

  • Queen Elizabeth Hospital Birmingham

    Edgbaston, Birmingham, B15 2GW

    Diane Griffiths, Diane.Griffiths@uhb.nhs.uk

    David Thickett, MD

    Recruiting

  • Royal Infirmary of Edinburgh

    Edinburgh, Scotland, EH16 4SA

    Manjit Cartlidge, MD

    Recruiting

  • Royal Devon and Exeter Hospital

    Exeter, Devon, EX2 5DW

    Ana Maria Adam, rduh.respiratoryresearch@nhs.net

    Michael Gibbons, MD

    Recruiting

  • University College Hospital - PPDS

    London, England, NW12PG

    Donna Basire, d.basire@ucl.ac.uk

    Joanna Porter, MD

    Recruiting

  • Royal Brompton Hospital

    London, SW3 6HP

    JB Astom, J.astom@nhs.net

    Philip Molyneaux, MD

    Recruiting

  • Churchill Hospital

    Oxford, Oxfordshire, OX3 7LE

    Jane Okumoku, Jane.Okumoku@ouh.nhs.uk

    Peter Saunders, MD

    Recruiting

  • Royal Papworth Hospital

    Trumpington, Cambridge, CB2 0AY

    Nicole Main, Nicole.Main1@nhs.net

    Helen Parfrey, MD

    Recruiting

Other trials in United Kingdom

Poland6 sites, 6 recruiting

  • Prywatny Gabinet Lekarski Ginekologia i Poloznictwo Ultrasonografia Prof. Jacek Suzin

    Lodz, Lódzkie, 90-602

    Marta Jabłońska, jablonskamarta77@o2.pl

    Izabela Grabska-Kobylecka, MD

    Recruiting

  • Medical University of Łódź

    Lodz, Łódź Voivodeship, 90-153

    Sebastian Majewski, MD, sebastian.majewski@umed.lodz.pl

    Sebastian Majewski, MD, PhD

    Recruiting

  • Twoja Przychodnia NCM

    Nowa Sól, Lubusz Voivodeship, 67-100

    Anna Polanska-Eisler, MD, +48688388050, polanska@twojaprzychodnia.com

    Anna Polanska-Eisler, MD

    Recruiting

  • EMed Centrum Uslug Medycznych

    Rzeszów, Podkarpackie Voivodeship, 35-205

    Katarzyna Smialek, ksmialek@emed-cum.pl

    Tomasz Kazirod, MD

    Recruiting

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

    Sosnowiec, Silesian Voivodeship, 41-208

    Grzegorz Gasior, kontakt@pulmag.pl

    Grzegorz Gasior, MD, PhD

    Recruiting

  • Instytut Gruzlicy i Chrob Pluc

    Warsaw, Poland, 01-138

    Katarzyna Lewandowska, MD, k.lewandowska@igichp.edu.pl

    Katarzyna Lewandowska, MD

    Recruiting

Other trials in Poland

Australia5 sites, 5 recruiting

  • Box Hill Hospital

    Box Hill, Victoria, 3128

    Julia Lee, Julia.lee1@monash.edu

    Francis Thien, MD

    Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

    Jessica Bucciarelli, Jessica.Bucciarelli@health.nsw.gov.au

    Tamera Corte, MD

    Recruiting

  • Launceston Respiratory and Sleep Centre

    Launceston, Tasmania, 7250

    Liam Fassett, research@lstrsc.com.au

    Collin Chia, MD

    Recruiting

  • Lung Research Victoria

    Melbourne, Victoria, 3011

    Midhu Johny, mjohny@lungresearchvictoria.com.au

    Ian Glaspole, MD

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Tracey Burns, tracey.burns@health.nsw.gov.au

    Laura Glenn, MD, PhD

    Recruiting

Other trials in Australia

Romania4 sites, 4 recruiting

  • FutureMeds Bucharest - PPDS

    Bucharest, 31441

    Calin Ene, calin.ene@futuremeds.com

    Beatrice Mahler, MD

    Recruiting

  • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Craiova

    Craiova, 200515

    Mirela Albu, mirela_a21@yahoo.com

    Dragos Nicolosu, MD

    Recruiting

  • AI Clinical Research

    Sibiu, 550052

    Carmen Toma, carmen.toma@aiclinicalresearch.ro

    Mihai Dan Mircea Petriu, MD

    Not yet recruiting

  • Sf. Ioan cel Nou Emergency County Hospital

    Suceava, 720224

    Carmen Eugenia Vascovici, vascovici.carmen@gmail.com

    Sorin Nicolae, MD

    Not yet recruiting

Other trials in Romania

Bulgaria3 sites, 3 recruiting

  • MCpulmo-2018 Ltd

    Haskovo, 6300

    Mariyana Delchevska - Kalfova, tbbgmariyana@abv.bg

    Veselin Kalfov, MD

    Not yet recruiting

  • Diagnostic- Consultative Center Convex EOOD

    Sofia, 1680

    Yana Lozanova, yana@clinical-trials-bulgaria.com

    Georgi Hinkov, MD

    Recruiting

  • Diagnostic- Consultative Center Convex EOOD

    Sofia, 1680

    Yana Lozanova, yana@clinical-trials-bulgaria.com

    Kosta Kostov, MD, PhD

    Recruiting

Other trials in Bulgaria

Germany2 sites, 2 recruiting

  • Agaplesion Evangelisches Krankenhaus Mittelhessen

    Giessen, Hesse, 35398

    Olga Maurer, olga.maurer@agaplesion.de

    Amdreas Guenther, MD

    Recruiting

  • Thoraxklinik-Heidelberg gGmbH Studienzentrum ThoraxKliPS

    Heidelberg, Baden-Wurttemberg, 69126

    Pneumologie Studien, Pneumologie-Studien.THOR@med.uni-heidelberg.de

    Markus Polke, MD

    Recruiting

Other trials in Germany

About this study

Official title: 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

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.

Read more

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.

Being tested
LTI-03, Dry Powder Inhaler, Placebo
Keywords
Idiopathic Pulmonary Fibrosis, Antifibrotic, Interstitial Lung Disease
Medical subject headings
Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LTI-03Drug

    Caveolin-1-Scaffolding-Protein-Derived Peptide

  • Dry Powder InhalerDevice

    Plastiape Monodose RS01 Model 7

  • PlaceboDrug

    Lactose powder

Study groups in NCT06968845
Study groupRoleWhat they receive
(1) 2.5 mg LTI-03 capsule BIDExperimentalCaveolin-1-Scaffolding-Protein-Derived Peptide
Receives: Drug: LTI-03; Device: Dry Powder Inhaler
(2) 2.5 mg LTI-03 capsules BIDExperimentalCaveolin-1-Scaffolding-Protein-Derived Peptide
Receives: Drug: LTI-03; Device: Dry Powder Inhaler
(1) Placebo capsule BIDPlacebo comparatorLactose powder
Receives: Device: Dry Powder Inhaler; Drug: Placebo
(2) Placebo capsules BIDPlacebo comparatorLactose powder
Receives: Device: Dry Powder Inhaler; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability as measured by the incidence of treatment-emergent adverse events (TEAEs)

    Measured: Day 1 through Week 24

Secondary outcomes (3)

  1. Change from baseline in forced vital capacity (FVC)

    Measured: Day 1 through Week 24

  2. Change from baseline in percent predicted FVC

    Measured: Day 1 through Week 24

  3. Change from baseline in lung fibrosis measured by high resolution computed tomography (HRCT)

    Measured: Day 1 through Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2025
  2. Study start2 Feb 2026
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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 below. * Low dose LTI-03 (N=40) 1 inhaled capsule twice a day * Low dose placebo (N=20) 1 inhaled capsule twice a day * High dose LTI-03 (N=40) 2 inhaled capsules twice a day * High dose placebo (N=20) 2 inhaled capsules twice a day
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06968845
Sponsor's protocol ID
LTI-03-2001 (RENEW)
Status last verified
Mar 2026
First submitted
28 Apr 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LTI-03 and Dry Powder Inhaler in people with Idiopathic Pulmonary Fibrosis (IPF), run by Rein Therapeutics at 48 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, United Kingdom, Poland, Australia, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Steven A. Shoemaker, MD (720-560-2167, sshoemaker@nicosof.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability as measured by the incidence of treatment-emergent adverse events (TEAEs) (time frame: Day 1 through Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06968845.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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