LTI-03 for Idiopathic Pulmonary Fibrosis

No longer recruiting at 8 trial locations

Overseen By Sydney Kruger, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Rein Therapeutics

Must not be taking: Antifibrotics, N-acetyl cysteine

Disqualifiers: Asthma, Obstructive lung disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of a new inhaled medication, LTI-03, for individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring and breathing problems. Participants will receive either a low dose, a higher dose, or a placebo (a substance with no active drug) to compare results. It suits those newly diagnosed with IPF who have not started other treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.

Do I need to stop my current medications to join the trial?

The trial requires that you stop using N-acetyl cysteine or other supplements 7 days before starting and throughout the treatment. If you're on antifibrotic therapy for IPF, you must stop it at least 2 months before the baseline bronchoscopy.

Is there any evidence suggesting that LTI-03 is likely to be safe for humans?

Research has shown that inhaled LTI-03 is generally safe and well-tolerated. In earlier studies, participants used LTI-03 for 14 days without major problems. It appears to help with lung scarring and protect lung cells, offering promise for people with idiopathic pulmonary fibrosis (IPF). No evidence of harm to cells was found, which is a positive sign. While these results are encouraging, it is important to remember that this is an early-stage trial, so more research is needed to confirm long-term safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for idiopathic pulmonary fibrosis, like nintedanib and pirfenidone, work by slowing lung fibrosis. But LTI-03 works differently, targeting pathways that could potentially reduce inflammation and fibrosis more effectively. Researchers are excited about LTI-03 because it offers a novel approach, with two different dosing options (2.5 mg and 5 mg twice daily) that could provide flexibility in managing the condition. Additionally, its potential to act quickly over just 14 days makes it a promising alternative for more immediate relief compared to traditional therapies.

What evidence suggests that LTI-03 might be an effective treatment for IPF?

Research has shown that LTI-03 could be a promising treatment for idiopathic pulmonary fibrosis (IPF). In lab studies, LTI-03 reduced lung scarring and protected lung cells, suggesting it might slow the lung damage caused by IPF. It also prevented the buildup of excess fibrous tissue. Additionally, LTI-03 lowered harmful proteins and pathways linked to lung scarring. Studies in which participants inhaled LTI-03 showed it is generally well-tolerated and may positively affect lung health. Overall, these findings support LTI-03 as a potential new therapy for IPF. ^{1 2 4 6 7}

Who Is on the Research Team?

Steven A. Shoemkaer, MD

Principal Investigator

Lung Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults over 40 with newly diagnosed Idiopathic Pulmonary Fibrosis (IPF), confirmed by specific tests, who haven't been in other drug studies recently. They must have certain lung function levels and can't be severely ill or unable to use the inhaler. Women of childbearing age and men with partners must agree to contraception.

Inclusion Criteria

Your lung function test shows that your lungs can take in a certain amount of air, but not too much.

You are 40 years old or older.

You have been diagnosed with IPF within the past 3 years, confirmed by a special type of chest scan or a lung biopsy following specific medical guidelines.

Exclusion Criteria

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)

Vaccination within 2 weeks of start of dosing (Day 1) and throughout the Treatment Period

You are unable to use the inhaler properly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LTI-03 or placebo by inhalation for 14 days using a dry-powder inhaler

2 weeks

Self-administered

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• LTI-03

Trial Overview

The study is testing LTI-03, an inhaled medication for IPF patients who haven't had treatment before. Participants will either receive LTI-03 or a placebo to check how safe it is and how well they tolerate it.

How Is the Trial Designed?

Group I: 5 mg LTI-03 BID Experimental Treatment 1 Intervention

5 mg LTI-03 BID x 14 days

Group II: 2.5 mg LTI-03 BID Experimental Treatment 1 Intervention

2.5 mg LTI-03 BID x 14 days

Group III: Placebo Placebo Group 1 Intervention

Matching placebo BID x 14 days

Who Is Running the Clinical Trial?

Rein Therapeutics

Lead Sponsor

Lung Therapeutics, Inc

Lead Sponsor

Trials

3

Recruited

140+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06968845

NCT06968845 | A Phase 2 Study of LTI-03 in Patients With ...

As the disease progresses, patients experience loss of lung function and increased breathing problems. LTI-03 is hypothesized to treat IPF by protecting and ...

2.

investors.aileronrx.com

investors.aileronrx.com/news-releases/news-release-details/rein-therapeutics-announces-publication-new-translational-data

Release Details

In this model, LTI-03 showed signs of reducing scarring and protecting lung cells, reinforcing its potential as an important new therapy. Key ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12496166/

LTI-03 peptide demonstrates anti-fibrotic activity in ex vivo ...

LTI-03 inhibits profibrotic and inflammatory mediators in idiopathic pulmonary fibrosis precision cut lung slice supernatants after 2 and 5 days of treatment.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589004225016980

LTI-03 peptide demonstrates anti-fibrotic activity in ex vivo ...

LTI-03 dose-dependently reduced collagen protein levels, suppressed pro-fibrotic cytokines, inhibited pro-fibrotic pathways, and activated ...

5.

labs.sciety.org

labs.sciety.org/articles/by?article_doi=10.1101/2025.10.28.25338981

Inhaled LTI-03 for Idiopathic Pulmonary Fibrosis

Inhaled LTI-03 exhibited a favorable safety and tolerability profile over 14 days. Exploratory biomarker analyses suggest a positive effect on ...

6.

medrxiv.org

medrxiv.org/content/10.1101/2025.10.28.25338981v1

Inhaled LTI-03 for Idiopathic Pulmonary Fibrosis

Conclusions: Inhaled LTI-03 exhibited a favorable safety and tolerability profile over 14 days. Exploratory biomarker analyses suggest a ...

7.

investors.aileronrx.com

investors.aileronrx.com/news-releases/news-release-details/aileron-therapeutics-announces-positive-topline-data-cohort-2

Aileron Therapeutics Announces Positive Topline Data ...

The primary objective of the study is to investigate the safety and tolerability of LTI-03 in patients with IPF after treatment for 14 ...