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NCT06968845 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
A Phase 2 study of Idiopathic Pulmonary Fibrosis (IPF), sponsored by Rein Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 5
- Study locations
NCT06968845 is a Phase 2 study of Idiopathic Pulmonary Fibrosis (IPF) that is actively recruiting participants, run by Rein Therapeutics. The registered enrollment target is 120 participants, below the 482-participant average among 8 other Idiopathic Pulmonary Fibrosis (IPF) trials with a reported enrollment target (75% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT06968845, a Phase 2 study of Idiopathic Pulmonary Fibrosis (IPF), is actively recruiting participants, sponsored by Rein Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 5
- Study locations
Study Summary
Rationale: LTI-03 is an experimental medication breathed into the lungs using an inhaler. It is being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a progressive, fatal lung disease caused by the death of lung cells involved in oxygen uptake and by progressive fibrosis (scarring) of the lungs. As the disease progresses, patients experience loss of lung function and increased breathing problems. LTI-03 is hypothesized to treat IPF by protecting and restoring the function of the oxygen uptake cells and by controlling lung fibrosis which may result in improving lung scarring. The purpose of this research is to evaluate LTI-03 including: its safety, whether it causes side effects, whether it improves lung scarring, and whether it improves IPF symptoms. LTI-03 will be compared to placebo in patients diagnosed with IPF within the last 5 years. Patients on a stable dose of nintedanib, pirfenidone, or nerandomilast (if available by prescription) may participate. Trial Design: This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study that includes a 28-day Screening Period, a 24-week Treatment Period, and 4-week Follow-up Period. Study Assessments: Up to 9 visits to the study clinic will be required. Safety and tolerability will be evaluated with the following assessments: physical examination; collection of vital sign data (heart rate, blood pressure, respiratory rate and peripheral oxygen saturation \[SpO2\] via pulse oximetry); heart data collected by 12-lead electrocardiogram; and collection of blood samples for safety laboratory tests. In addition, participants will be asked about any adverse events (side effects) they have experienced between clinic visits, if they have changed any medications, and if they are able to properly use their study drug inhaler. Participants will undergo a lung function test (spirometry) at every visit, which will be used to evaluate both safety and efficacy. Another test measuring th
Conditions Studied
Interventions
- DRUG Placebo
- DEVICE Dry Powder Inhaler
- DRUG LTI-03
Study Locations (5)
Alabama
- UAB Lung Health Center - Birmingham
California
- Paradigm Clinical Research Centers, LLC - San Diego
Missouri
- The Lung Research Center, LLC - Chesterfield
South Carolina
- Medical University of South Carolina - Charleston
Texas
- El Paso Pulmonary Association - El Paso
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2026-02-02 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06968845
The ClinicalTrials.gov registry entry for NCT06968845 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 8 other Idiopathic Pulmonary Fibrosis (IPF) trials with a reported enrollment target (75% lower). The listed sponsor is Rein Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Idiopathic Pulmonary Fibrosis (IPF) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06968845 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Alabama, California, Missouri.
Frequently Asked Questions
What is clinical trial NCT06968845 about?
NCT06968845 is a clinical study titled "A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis". Rationale: LTI-03 is an experimental medication breathed into the lungs using an inhaler. It is being studied for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a progressive, fatal lung disease caused by the death of lung cells involved in oxygen uptake and by progressive fibrosis (sc...
What is the current status of trial NCT06968845?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2026-02-02. Estimated completion is 2027-12-31.
What conditions does trial NCT06968845 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis (IPF).
What interventions are being tested in trial NCT06968845?
The interventions under investigation include: Placebo (DRUG), Dry Powder Inhaler (DEVICE), LTI-03 (DRUG).
Who is sponsoring clinical trial NCT06968845?
This trial is sponsored by Rein Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06968845 being conducted?
This trial has 5 study locations across Alabama, California, Missouri, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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