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
This study will assess the safety and tolerability of inhaled LTI-03 in treatment naïve participants with newly diagnosed IPF.
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.
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 →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.
Exclusion Criteria:
2.5 mg LTI-03 BID x 14 days
Drug: LTI-03
5 mg LTI-03 BID x 14 days
Drug: LTI-03
Matching placebo BID x 14 days
Drug: Placebo
Caveolin-1-Scaffolding-Protein-Derived Peptide
Also known as: Micronized dry powder in hard 2 piece hypromellose capsules
Matching placebo
Also known as: Micronized lactose powder in capsule
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)
| Milestone | 2.5 mg LTI-03 BID | 5 mg LTI-03 BID | Placebo |
|---|---|---|---|
| Started | 9 | 9 | 6 |
| Completed | 9 | 9 | 6 |
| Not completed | 0 | 0 | 0 |
Incidence of TEAEs by dose
| percentage of participants | 2.5 mg LTI-03 BID | 5 mg LTI-03 BID | Placebo |
|---|---|---|---|
| Any TEAE | 66.7 | 77.8 | 50.0 |
| Any TEAE with CTCAE severity Grade 3 or higher | 0 | 0 | 0 |
| Any study drug-related TEAE | 22.2 | 55.6 | 16.7 |
| Any TEAE leading to treatment discontinuation | 0 | 0 | 0 |
| Any serious TEAE | 0 | 11.1 | 0 |
| Any TEAE leading to death | 0 | 0 | 0 |
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 2.5 mg LTI-03 BID | 0/9 (0%) | 0/9 (0%) | 6/9 (66.7%) |
| 5 mg LTI-03 BID | 0/9 (0%) | 1/9 (11.1%) | 7/9 (77.8%) |
| Placebo | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Event | 2.5 mg LTI-03 BID | 5 mg LTI-03 BID | Placebo |
|---|---|---|---|
| Post-procedural feverInjury, poisoning and procedural complications | 0/9 | 1/9 | 0/6 |
| Event | 2.5 mg LTI-03 BID | 5 mg LTI-03 BID | Placebo |
|---|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 3/9 | 5/9 | 2/6 |
| DizzinessNervous system disorders | 0/9 | 0/9 | 1/6 |
| Esophageal spasmGastrointestinal disorders | 0/9 | 0/9 | 1/6 |
| PalpitationsCardiac disorders | 0/9 | 1/9 | 0/6 |
| DysgeusiaNervous system disorders | 1/9 | 0/9 | 0/6 |
| Ophthalmic migraineNervous system disorders | 1/9 | 0/9 | 0/6 |
| Chest discomfortGeneral disorders | 1/9 | 0/9 | 0/6 |
| FatigueGeneral disorders | 1/9 | 0/9 | 0/6 |
| VertigoEar and labyrinth disorders | 0/9 | 1/9 | 0/6 |
| Dry mouthGastrointestinal disorders | 0/9 | 1/9 | 0/6 |
| Age, Categorical(Participants) | 2.5 mg LTI-03 BID | 5 mg LTI-03 BID | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 3 | 1 | 8 |
| >=65 years | 5 | 6 | 5 | 16 |
| Age, Continuous(years) | 2.5 mg LTI-03 BID | 5 mg LTI-03 BID | Placebo | Total |
|---|---|---|---|---|
| Mean | 67.8 ± 9.76 | 68.4 ± 10.79 | 71.7 ± 6.15 | 69.0 ± 9.19 |
| Sex: Female, Male(Participants) | 2.5 mg LTI-03 BID | 5 mg LTI-03 BID | Placebo | Total |
|---|---|---|---|---|
| Female | 2 | 2 | 0 | 4 |
| Male | 7 | 7 | 6 | 20 |
| Ethnicity (NIH/OMB)(Participants) | 2.5 mg LTI-03 BID | 5 mg LTI-03 BID | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 9 | 9 | 6 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 2.5 mg LTI-03 BID | 5 mg LTI-03 BID | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 9 | 9 | 6 | 24 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | 2.5 mg LTI-03 BID | 5 mg LTI-03 BID | Placebo | Total |
|---|---|---|---|---|
| United States | 2 | 1 | 0 | 3 |
| United Kingdom | 3 | 2 | 3 | 8 |
| Germany | 3 | 4 | 2 | 10 |
| Australia | 1 | 2 | 1 | 3 |
| Height(cm) | 2.5 mg LTI-03 BID | 5 mg LTI-03 BID | Placebo | Total |
|---|---|---|---|---|
| Mean | 170.93 ± 9.270 | 169.56 ± 9.530 | 177.17 ± 7.111 | 171.98 ± 9.067 |
| Weight(kg) | 2.5 mg LTI-03 BID | 5 mg LTI-03 BID | Placebo | Total |
|---|---|---|---|---|
| Mean | 84.49 ± 11.709 | 85.36 ± 25.108 | 91.45 ± 11.529 | 86.55 ± 17.446 |
8 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Idiopathic Pulmonary Fibrosis→
Rein Therapeutics