Idiopathic Pulmonary FibrosisPhase 1NCT05954988
A Study to Evaluate LTI-03 in Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) Patients
A Phase 1 study testing LTI-03 in people with Idiopathic Pulmonary Fibrosis, run by Rein Therapeutics at 7 sites in 3 countries.
Trial summary
This study will assess the safety and tolerability of inhaled LTI-03 in treatment naïve participants with newly diagnosed IPF. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- LTI-03
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 6 Jul 2023to 25 Sep 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 subject of age 40 years or older.
- Willing and able to provide written informed consent.
- Diagnosis of IPF within 3 years of Screening as confirmed by HRCT of chest or lung biopsy as defined by ATS/ERS/JRS/ALAT guideline.
- Forced vital capacity (FVC) percent predicted ≥ 40%.
- Diffusion capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥ 30 and ≤ 80.
- Forced expiratory volume 1 (FEV1)/FVC ≥ 0.7.
Who cannot join
- Interstitial lung disease other than IPF.
- Evidence of significant obstructive lung disease.
- Current diagnosis of asthma.
- Treatment with an approved or investigational antifibrotic therapy for IPF within 2 months of the Baseline bronchoscopy.
- Use of N-acetyl cysteine or other supplements within 7 days prior to dosing and throughout the Treatment Period.
- Inability to use study inhaler device appropriately.
Show all 17Show fewer
- Pulmonary exacerbation within 6 months prior to Screening.
- Febrile illness within 7 days prior to dosing.
- Participation in a clinical study or treatment with an investigational drug or device within 30 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 eGFR < 30 mL/min (region specific).
- 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 (region specific).
- Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol.
- Vaccination within 2 weeks of start of dosing (Day 1) and throughout the Treatment Period.
- Subject has severe progressive or uncontrolled, clinically significant disease that in the judgment of the investigator or designee renders the subject unsuitable for the study.
- Positive urine pregnancy test in female subjects of childbearing potential as defined below.
- Female subjects 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 subjects who do not agree to refrain from donating sperm during this same period.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States3 sites
University of Alabama
Birmingham, Alabama, 35294
University of Southern California
Los Angeles, California, 90033
Cedars Sinai Medical Center
Los Angeles, California, 90048
United Kingdom3 sites
University of Edinburgh
Edinburgh
Royal Brompton Hospital
London, SW3 6HP
Royal Victoria Infirmary
Newcastle
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Safety, Tolerability and Pharmacodynamic Biomarker Study of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Recently Diagnosed, Treatment Naïve Subjects With IPF
This study will assess the safety and tolerability of inhaled LTI-03 in treatment naïve participants with newly diagnosed IPF.
Read the detailed description
This is a randomized, double-blind, placebo controlled, multi-center, dose escalation, safety and tolerability study of LTI-03 or placebo administered by inhalation in participants recently diagnosed with idiopathic pulmonary fibrosis that have not received prior treatment with anti-fibrotic agents.
The study will contain 2 dose cohorts which will run sequentially.
Eligible participants will be randomized in a 3:1 ratio to either LTI-03 or placebo. Safety data will be reviewed on an ongoing basis. Enrollment in the second cohort will not begin until the Cohort 1 safety data has been reviewed.
The Treatment Period will be 14 days, with subjects self-administering study drug using a provided commercially available dry-powder inhaler.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- LTI-03, Placebo
- Keywords
- IPF, idiopathic pulmonary fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTI-03Drug
Also called Micronized dry powder in hard 2 piece hypromellose capsules
Caveolin-1-Scaffolding-Protein-Derived Peptide
PlaceboDrug
Also called Micronized lactose powder in capsule
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 2.5 mg LTI-03 BID | Experimental | 2.5 mg LTI-03 BID x 14 days Receives: Drug: LTI-03 |
| 5 mg LTI-03 BID | Experimental | 5 mg LTI-03 BID x 14 days Receives: Drug: LTI-03 |
| Placebo | Placebo comparator | Matching placebo BID x 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent Adverse Events (TEAEs)
Incidence of TEAEs by dose
Measured: 21 days (dosing x 14 days; follow up x 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start6 Jul 2023
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rein Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven A. Shoemkaer, MD, Study director, Lung Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954988
- Sponsor's protocol ID
- LTI-03-1002
- Status last verified
- Jul 2025
- First submitted
- 20 May 2022
- Last updated
- 31 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Molyneaux PL, Hirani NA, Chia CCK, Kulkarni T, Zaman T, Kaner RJ, Coelho AL, Jannini-Sa YAP, Windsor B, Kruger S, Christensen DJ, Shoemaker SA, Hogaboam CM, MacKenzie B, Gunther A. Inhaled LTI-03 for idiopathic pulmonary fibrosis: a randomized dose escalation study. Nat Commun. 2026 Jul 31;17(1):7620. doi: 10.1038/s41467-026-75291-3.
PubMed 42538332
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Safety, Tolerability and Pharmacodynamic Biomarker Study of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Recently Diagnosed, Treatment Naïve Subjects With IPF
- ClinicalTrials.gov ID
- NCT05954988
- Acronym / sponsor ID
- LTI-03-1002
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- IPF, idiopathic pulmonary fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rein TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 20 Jul 2023 (actual)
- Results
- Posted 31 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and tolerability of inhaled LTI-03 in treatment naïve participants with newly diagnosed IPF.
Detailed description
This is a randomized, double-blind, placebo controlled, multi-center, dose escalation, safety and tolerability study of LTI-03 or placebo administered by inhalation in participants recently diagnosed with idiopathic pulmonary fibrosis that have not received prior treatment with anti-fibrotic agents.
The study will contain 2 dose cohorts which will run sequentially.
Eligible participants will be randomized in a 3:1 ratio to either LTI-03 or placebo. Safety data will be reviewed on an ongoing basis. Enrollment in the second cohort will not begin until the Cohort 1 safety data has been reviewed.
The Treatment Period will be 14 days, with subjects self-administering study drug using a provided commercially available dry-powder inhaler.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2.5 mg LTI-03 BID | Experimental | Drug: LTI-032.5 mg LTI-03 BID x 14 days |
| 5 mg LTI-03 BID | Experimental | Drug: LTI-035 mg LTI-03 BID x 14 days |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo BID x 14 days |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subject of age 40 years or older.
- Willing and able to provide written informed consent.
- Diagnosis of IPF within 3 years of Screening as confirmed by HRCT of chest or lung biopsy as defined by ATS/ERS/JRS/ALAT guideline.
- Forced vital capacity (FVC) percent predicted ≥ 40%.
- Diffusion capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥ 30 and ≤ 80.
Key exclusion criteria (17 listed)
- Interstitial lung disease other than IPF.
- Evidence of significant obstructive lung disease.
- Current diagnosis of asthma.
- Treatment with an approved or investigational antifibrotic therapy for IPF within 2 months of the Baseline bronchoscopy.
- Use of N-acetyl cysteine or other supplements within 7 days prior to dosing and throughout the Treatment Period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTI-03Also: Micronized dry powder in hard 2 piece hypromellose capsulesCaveolin-1-Scaffolding-Protein-Derived Peptide | Drug | 2.5 mg LTI-03 BID, 5 mg LTI-03 BID |
| PlaceboAlso: Micronized lactose powder in capsuleMatching placebo | Drug | Placebo |
Primary outcome
Incidence of Treatment-emergent Adverse Events (TEAEs)
Time frame: 21 days (dosing x 14 days; follow up x 7 days)
Incidence of TEAEs by dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42538332Molyneaux PL, Hirani NA, Chia CCK, Kulkarni T, Zaman T, Kaner RJ, Coelho AL, Jannini-Sa YAP, Windsor B, Kruger S, Christensen DJ, Shoemaker SA, Hogaboam CM, MacKenzie B, Gunther A. Inhaled LTI-03 for idiopathic pulmonary fibrosis: a randomized dose escalation study. Nat Commun. 2026 Jul 31;17(1):7620. doi: 10.1038/s41467-026-75291-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven A. Shoemkaer, MD study director
Lung Therapeutics
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LTI-03 in people with Idiopathic Pulmonary Fibrosis, run by Rein Therapeutics at 7 sites in 3 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, United Kingdom, Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-emergent Adverse Events (TEAEs) (time frame: 21 days (dosing x 14 days; follow up x 7 days)). 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 NCT05954988, which also lists 1 linked publication.
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 31 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.