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NCT06968845

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

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 24 versions: 23 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 48 sites
  2. Site details revised at 8 of 48 sites
  3. Site contacts updated at 2 of 48 sites
  4. Eligibility criteria shortened, about 1 word
    • Trial sites expanded: 36 → 48 locations
  5. Site details revised at 1 of 36 sitesv20
  6. Trial sites expanded: 30 → 36 locationsv19
  7. Study sites revised (30)v18
  8. Trial sites expanded: 21 → 30 locationsv17
  9. Study sites: 20 to 21v15
  10. Trial sites expanded: 16 → 19 locationsv14
  11. Study sites: 16 to 19v13
  12. Trial sites expanded: 11 → 14 locationsv12
  13. Study sites: 11 to 14v11
  14. Study sites: 9 to 11v10
  15. Study sites: 7 to 9v9
  16. Study sites: 6 to 7v8
  17. Study sites: 5 to 6v7
  18. Study sites: 3 to 5v6
  19. Study sites: 2 to 3v5
  20. Trial status: Active, Not Recruiting to Recruitingv4 Show 5 more changesShow less
    • Start date: May 2, 2025 to Feb 2, 2026
    • Eligibility criteria expanded, about 4 words
    • Primary completion date: May 28, 2027 to Sep 30, 2027
    • Study completion date: May 28, 2027 to Dec 31, 2027
    • Site details revised at 2 of 2 sites
  21. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v3
  22. Study sites: 1 to 2v2
  23. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Safety and Tolerability as measured by the incidence of treatment-emergent adverse events (TEAEs)
Timeframe: Day 1 through Week 24

Secondary (3)

Change from baseline in forced vital capacity (FVC)
Change from baseline in percent predicted FVC
Change from baseline in lung fibrosis measured by high resolution computed tomography (HRCT)

Arms and interventions

(1) 2.5 mg LTI-03 capsule BIDExperimental

Caveolin-1-Scaffolding-Protein-Derived Peptide

(2) 2.5 mg LTI-03 capsules BIDExperimental

Caveolin-1-Scaffolding-Protein-Derived Peptide

(1) Placebo capsule BIDPlacebo comparator

Lactose powder

(2) Placebo capsules BIDPlacebo comparator

Lactose powder

Drugs: LTI-03, Placebo

Devices: Dry Powder Inhaler

Sites

48 sites in 7 countries

United States 20, United Kingdom 8, Poland 6, Australia 5, Romania 4, Bulgaria 3, Germany 2