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

NCT05954988 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: LTI-03-1002
• Study Type: interventional
• Target: 24
• Locations: 3 countries
• Sites: 7

Brief Summary

This study will assess the safety and tolerability of inhaled LTI-03 in treatment naïve participants with newly diagnosed IPF.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

IPF; idiopathic pulmonary fibrosis

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-emergent Adverse Events (TEAEs)

  Incidence of TEAEs by dose

  21 days (dosing x 14 days; follow up x 7 days)

Study Arms (3)

2.5 mg LTI-03 BID

EXPERIMENTAL

2.5 mg LTI-03 BID x 14 days

Drug: LTI-03

5 mg LTI-03 BID

EXPERIMENTAL

5 mg LTI-03 BID x 14 days

Drug: LTI-03

Placebo

PLACEBO COMPARATOR

Matching placebo BID x 14 days

Drug: Placebo

Interventions

LTI-03 DRUG

Caveolin-1-Scaffolding-Protein-Derived Peptide

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

2.5 mg LTI-03 BID; 5 mg LTI-03 BID

Placebo DRUG

Matching placebo

Also known as: Micronized lactose powder in capsule

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rein Therapeutics: lead

Study Sites (7)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Agaplesion Evangelisches Krankenhaus Mittelhessen

Giessen, Germany

Location

University of Edinburgh

Edinburgh, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6HP, United Kingdom

Location

Royal Victoria Infirmary

Newcastle, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Capsules

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Shawna Evans
• Organization: Rein Therapeutics, Inc.

info@reintx.com

1 (737) 802-1989

Study Officials

• Steven A. Shoemkaer, MD

  Lung Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Sponsor, Investigator, and study personnel working on behalf of the Investigator and Sponsor will remain blinded.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: July 20, 2023
• Study Start: July 6, 2023
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Locations

DE (1); US (3); GB (3)