NCT05954988

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Rein Therapeutics · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	LTI-03	Caveolin-1-Scaffolding-Protein-Derived Peptide
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2023-07-06
• Primary completion: 2024-09-25
• Completion: 2024-09-25
• First posted: 2023-07-20
• Last updated: 2025-07-31
• Results posted: 2025-07-31

Locations

7 sites across 3 countries: United States, Germany, United Kingdom

Regulatory

• FDA-regulated drug study