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CompletedNCT05954988Updated Jul 31, 2025Results posted

A Study to Evaluate LTI-03 in Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) Patients

A Phase 1 interventional study of LTI-03 and Placebo in Idiopathic Pulmonary Fibrosis, sponsored by Rein Therapeutics. Completed at 7 sites in 3 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-07-31.

Sponsored by Rein Therapeutics · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis

Keywords

  • IPF
  • idiopathic pulmonary fibrosis
03

In context

Idiopathic Pulmonary Fibrosis

551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.

This study's enrollment of 24 is below the median of 54 across 376 interventional studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

Rein Therapeutics is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female subject of age 40 years or older.
  2. Willing and able to provide written informed consent.
  3. 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.
  4. Forced vital capacity (FVC) percent predicted ≥ 40%.
  5. Diffusion capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥ 30 and ≤ 80.
  6. Forced expiratory volume 1 (FEV1)/FVC ≥ 0.7.

Exclusion criteria

Exclusion Criteria:

  1. Interstitial lung disease other than IPF.
  2. Evidence of significant obstructive lung disease.
  3. Current diagnosis of asthma.
  4. Treatment with an approved or investigational antifibrotic therapy for IPF within 2 months of the Baseline bronchoscopy.
  5. Use of N-acetyl cysteine or other supplements within 7 days prior to dosing and throughout the Treatment Period.
  6. Inability to use study inhaler device appropriately.
  7. Pulmonary exacerbation within 6 months prior to Screening.
  8. Febrile illness within 7 days prior to dosing.
  9. 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).
  10. History or evidence at screening of significant renal impairment with eGFR \< 30 mL/min (region specific).
  11. 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).
  12. Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol.
  13. Vaccination within 2 weeks of start of dosing (Day 1) and throughout the Treatment Period.
  14. 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.
  15. Positive urine pregnancy test in female subjects of childbearing potential as defined below.
  16. Female subjects who are lactating.
  17. 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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    2.5 mg LTI-03 BID

    2.5 mg LTI-03 BID x 14 days

    Drug: LTI-03

  • Experimental
    5 mg LTI-03 BID

    5 mg LTI-03 BID x 14 days

    Drug: LTI-03

  • Placebo comparator
    Placebo

    Matching placebo BID x 14 days

    Drug: Placebo

Interventions

  • DrugLTI-03

    Caveolin-1-Scaffolding-Protein-Derived Peptide

    Also known as: Micronized dry powder in hard 2 piece hypromellose capsules

  • DrugPlacebo

    Matching placebo

    Also known as: Micronized lactose powder in capsule

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment-emergent Adverse Events (TEAEs)

    Incidence of TEAEs by dose

    Time frame: 21 days (dosing x 14 days; follow up x 7 days)

07

Results

Posted Jul 31, 2025

Participant flow

Participant flow — Overall Study
Milestone2.5 mg LTI-03 BID5 mg LTI-03 BIDPlacebo
Started996
Completed996
Not completed000

Outcome measures

PrimaryIncidence of Treatment-emergent Adverse Events (TEAEs)

Incidence of TEAEs by dose

Time frame:
21 days (dosing x 14 days; follow up x 7 days)
Reported as:
Number · percentage of participants
Incidence of Treatment-emergent Adverse Events (TEAEs)
percentage of participants2.5 mg LTI-03 BID5 mg LTI-03 BIDPlacebo
Any TEAE66.777.850.0
Any TEAE with CTCAE severity Grade 3 or higher000
Any study drug-related TEAE22.255.616.7
Any TEAE leading to treatment discontinuation000
Any serious TEAE011.10
Any TEAE leading to death000

Adverse events

Collected over From ICF (if serious or related to protocol assessment) or Dosing Day 1 through End of Study Day 21. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
2.5 mg LTI-03 BID0/9 (0%)0/9 (0%)6/9 (66.7%)
5 mg LTI-03 BID0/9 (0%)1/9 (11.1%)7/9 (77.8%)
Placebo0/6 (0%)0/6 (0%)3/6 (50%)
Most frequent serious events
Most frequent serious events
Event2.5 mg LTI-03 BID5 mg LTI-03 BIDPlacebo
Post-procedural feverInjury, poisoning and procedural complications0/91/90/6
Most frequent other events
Showing 10 of 20
Most frequent other events
Event2.5 mg LTI-03 BID5 mg LTI-03 BIDPlacebo
CoughRespiratory, thoracic and mediastinal disorders3/95/92/6
DizzinessNervous system disorders0/90/91/6
Esophageal spasmGastrointestinal disorders0/90/91/6
PalpitationsCardiac disorders0/91/90/6
DysgeusiaNervous system disorders1/90/90/6
Ophthalmic migraineNervous system disorders1/90/90/6
Chest discomfortGeneral disorders1/90/90/6
FatigueGeneral disorders1/90/90/6
VertigoEar and labyrinth disorders0/91/90/6
Dry mouthGastrointestinal disorders0/91/90/6

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)2.5 mg LTI-03 BID5 mg LTI-03 BIDPlaceboTotal
<=18 years0000
Between 18 and 65 years4318
>=65 years56516
Age, Continuous
Age, Continuous(years)2.5 mg LTI-03 BID5 mg LTI-03 BIDPlaceboTotal
Mean67.8 ± 9.7668.4 ± 10.7971.7 ± 6.1569.0 ± 9.19
Sex: Female, Male
Sex: Female, Male(Participants)2.5 mg LTI-03 BID5 mg LTI-03 BIDPlaceboTotal
Female2204
Male77620
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)2.5 mg LTI-03 BID5 mg LTI-03 BIDPlaceboTotal
Hispanic or Latino0000
Not Hispanic or Latino99624
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)2.5 mg LTI-03 BID5 mg LTI-03 BIDPlaceboTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White99624
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)2.5 mg LTI-03 BID5 mg LTI-03 BIDPlaceboTotal
United States2103
United Kingdom3238
Germany34210
Australia1213
Height
Height(cm)2.5 mg LTI-03 BID5 mg LTI-03 BIDPlaceboTotal
Mean170.93 ± 9.270169.56 ± 9.530177.17 ± 7.111171.98 ± 9.067
Weight
Weight(kg)2.5 mg LTI-03 BID5 mg LTI-03 BIDPlaceboTotal
Mean84.49 ± 11.70985.36 ± 25.10891.45 ± 11.52986.55 ± 17.446

8 further baseline measures are reported on the registry.

08

Study locations

7 sites
  • University of Alabama
    Birmingham, Alabama 35294, United States
  • University of Southern California
    Los Angeles, California 90033, United States
  • Cedars Sinai Medical Center
    Los Angeles, California 90048, United States
  • Agaplesion Evangelisches Krankenhaus Mittelhessen
    Giessen, Germany
  • University of Edinburgh
    Edinburgh, United Kingdom
  • Royal Brompton Hospital
    London, SW3 6HP, United Kingdom
  • Royal Victoria Infirmary
    Newcastle, United Kingdom
09

References and documents

Study documents

  • Study protocol · May 4, 2023
  • Statistical analysis plan · Oct 21, 2024

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05954988
Lead sponsor
Rein Therapeutics
Responsible party
Sponsor
First posted
Jul 20, 2023
Start date
Jul 6, 2023
Primary completion
Sep 25, 2024
Completion
Sep 25, 2024
Results posted
Jul 31, 2025
Last update
Jul 31, 2025

Study contacts

Steven A. Shoemkaer, MD
study director · Lung Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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