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

NCT06968845 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: LTI-03-2001 (RENEW)
• Study Type: interventional
• Target: 120
• Locations: 3 countries
• Sites: 9

Brief 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 the diffusion capacity of the lungs for carbon monoxide (DLCO) will be required at Screening only. Blood samples will also be collected at each visit to measure disease biomarkers. At select visits patients will be asked to complete the Living with Pulmonary Fibrosis questionnaire to evaluate their IPF symptoms. Participants will also undergo a specialized lung scan (HRCT) at Baseline and at the End of Treatment to measure changes in lung fibrosis. Interventions: LTI-03 and placebo are provided in powder-filled capsules that participants will self- administer using an inhaler. Placebo capsules look like LTI-03 capsules but have no active ingredients. Approximately 120 participants will be randomly assigned in a blinded manner to one of study drug treatment groups.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Keywords

Idiopathic Pulmonary Fibrosis; Antifibrotic; Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability as measured by the incidence of treatment-emergent adverse events (TEAEs)

  Day 1 through Week 24

Secondary Outcomes (3)

• Change from baseline in forced vital capacity (FVC)

  Day 1 through Week 24

• Change from baseline in percent predicted FVC

  Day 1 through Week 24

• Change from baseline in lung fibrosis measured by high resolution computed tomography (HRCT)

  Day 1 through Week 24

Study Arms (4)

(1) 2.5 mg LTI-03 capsule BID

EXPERIMENTAL

Caveolin-1-Scaffolding-Protein-Derived Peptide

Drug: LTI-03; Device: Dry Powder Inhaler

(2) 2.5 mg LTI-03 capsules BID

EXPERIMENTAL

Caveolin-1-Scaffolding-Protein-Derived Peptide

Drug: LTI-03; Device: Dry Powder Inhaler

(1) Placebo capsule BID

PLACEBO COMPARATOR

Lactose powder

Device: Dry Powder Inhaler; Drug: Placebo

(2) Placebo capsules BID

PLACEBO COMPARATOR

Lactose powder

Device: Dry Powder Inhaler; Drug: Placebo

Interventions

LTI-03 DRUG

Caveolin-1-Scaffolding-Protein-Derived Peptide

(1) 2.5 mg LTI-03 capsule BID; (2) 2.5 mg LTI-03 capsules BID

Dry Powder Inhaler DEVICE

Plastiape Monodose RS01 Model 7

(1) 2.5 mg LTI-03 capsule BID; (1) Placebo capsule BID; (2) 2.5 mg LTI-03 capsules BID; (2) Placebo capsules BID

Placebo DRUG

Lactose powder

(1) Placebo capsule BID; (2) Placebo capsules BID

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 age 40 years or older.
• Willing and able to provide written informed consent.
• Diagnosis of IPF within 5 years of Screening as confirmed by a centrally read HRCT of the chest as defined by the ATS/ERS/JRS/ALAT guideline. HRCT lung fibrosis by central read during screening must involve ≥ 10% of the lung and be greater than emphysema involvement of the lung.
• Forced vital capacity (FVC) percent predicted ≥ 45% at Screening.
• Diffusion capacity of the lungs for carbon monoxide (DLCO), hemoglobin-corrected percent predicted ≥ 30% within 8 weeks prior to Randomization.
• Participants receiving nintedanib, pirfenidone, or nerandomilast (where approved for marketing) for IPF treatment must have been on a stable prescribed dose for at least 12 weeks prior to Randomization.
• Participants who previously received nintedanib, pirfenidone, or nerandomilast must have discontinued treatment at least 8 weeks prior to Randomization.
• Able to adequately self-administer study drug using the protocol-specified inhaler device.

You may not qualify if:

• Forced expiratory volume in 1 second (FEV1)/FVC \< 0.7 at Screening.
• Use of N-acetyl cysteine or other supplements including but not limited to quercetin, omega-3 fatty acids, dehydroepiandrosterone, polyphenols, and phytochemicals within 7 days prior to Randomization and through Week 24.
• Use of systemic corticosteroids at doses \> 10 mg/day of prednisone or equivalent within 28 days prior to Randomization.
• Active smoker.
• Pulmonary exacerbation within 3 months prior to Screening.
• Febrile pulmonary illness requiring antibiotic treatment within 28 days prior to Randomization.
• Participation in a clinical study or treatment with an investigational drug or device within 28 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 estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2.
• 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 while not on anticoagulant medication.
• Active or history of malignancies within 5 years prior to Randomization, with the exception of localized nonmetastatic basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or prostate cancer.
• Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol; or an expected survival of less than 24 weeks.
• Contraception and Pregnancy
• Positive pregnancy test in female participants of childbearing potential (defined below).
• Female participants who are lactating.
• Females of childbearing potential (FOCBP) and men with partners of childbearing potential who do not agree to use an acceptable form of contraception for the duration of study treatment and for at least 90 days after the last dose of study drug. Male participants who do not agree to refrain from donating sperm during this same period.

Sponsors & Collaborators

• Rein Therapeutics: lead

Study Sites (9)

UAB Lung Health Center

Birmingham, Alabama, 35233, United States

RECRUITING

Paradigm Clinical Research Centers, LLC

San Diego, California, 92108, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

The Lung Research Center, LLC

Chesterfield, Missouri, 63017, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Missouri, 66160, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

El Paso Pulmonary Association

El Paso, Texas, 79902, United States

RECRUITING

Launceston Respiratory and Sleep Centre

Launceston, Tasmania, 7250, Australia

RECRUITING

Salus Aegroti Praktyka Lekarska dr n. med. Grzegorz Gąsior

Sosnowiec, Silesian Voivodeship, 41-208, Poland

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial

Interventions

Dry Powder Inhalers

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Nebulizers and Vaporizers; Equipment and Supplies

Central Study Contacts

Steven A. Shoemaker, MD

CONTACT

720-560-2167; sshoemaker@nicosof.com

Shawna H. Evans

CONTACT

603-557-0005; sevans@reintx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Sponsor (1 unmasked Sponsor representative) CRO (1 Biostats individual is unmasked)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: LTI-03 and placebo are provided in powder-filled capsules that participants will self- administer using an inhaler. Placebo capsules look like LTI-03 capsules but have no active ingredients. Approximately 120 participants will be randomly assigned in a blinded manner to one of study drug treatment groups below. * Low dose LTI-03 (N=40) 1 inhaled capsule twice a day * Low dose placebo (N=20) 1 inhaled capsule twice a day * High dose LTI-03 (N=40) 2 inhaled capsules twice a day * High dose placebo (N=20) 2 inhaled capsules twice a day

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 13, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); AU (1); PL (1)