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LTI-03

Phase 2

Idiopathic Pulmonary Fibrosis (IPF) | Small molecule | Respiratory |Rein Therapeutics, Inc.|Last Updated: Sep 4, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment120

FDA Designations

ORPHAN_DRUGFAST_TRACK

Clinical trial landscape

LTI-03 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT06968845A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis (IPF)
RECRUITING120 Analytics
PHASE2RECRUITING
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability as measured by the incidence of treatment-emergent adverse events (TEAEs)
Day 1 through Week 24
Incidence of Treatment-emergent Adverse Events (TEAEs)
21 days (dosing x 14 days; follow up x 7 days)

Incidence of TEAEs by dose

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
(1) 2.5 mg LTI-03 capsule BIDEXPERIMENTALCaveolin-1-Scaffolding-Protein-Derived Peptide
(2) 2.5 mg LTI-03 capsules BIDEXPERIMENTALCaveolin-1-Scaffolding-Protein-Derived Peptide
(1) Placebo capsule BIDPLACEBO_COMPARATORLactose powder
(2) Placebo capsules BIDPLACEBO_COMPARATORLactose powder
2.5 mg LTI-03 BIDEXPERIMENTAL2.5 mg LTI-03 BID x 14 days
5 mg LTI-03 BIDEXPERIMENTAL5 mg LTI-03 BID x 14 days
PlaceboPLACEBO_COMPARATORMatching placebo BID x 14 days

Interventions

NameTypeDescription
LTI-03DRUGCaveolin-1-Scaffolding-Protein-Derived Peptide
Dry Powder InhalerDEVICEPlastiape Monodose RS01 Model 7
PlaceboDRUGLactose powder
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: 1. Male or female age 40 years or older. 2. Willing and able to provide written informed consent. 3. 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 d...

Countries:United StatesAustraliaGermanyPolandUnited Kingdom
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Recent Changes (Last 90 Days)

LOWSep 4, 2026NCT06968845lastUpdatePostDate: changed
LOWSep 4, 2026NCT06968845lastUpdatePostDate: changed
LOWAug 14, 2026NCT06968845lastUpdatePostDate: changed
LOWAug 14, 2026NCT06968845lastUpdatePostDate: changed
LOWAug 14, 2026NCT06968845lastUpdatePostDate: changed
LOWJul 28, 2026NCT06968845lastUpdatePostDate: changed
LOWJul 28, 2026NCT06968845lastUpdatePostDate: changed
LOWJul 24, 2026NCT06968845lastUpdatePostDate: changed
LOWJul 24, 2026NCT06968845lastUpdatePostDate: changed
LOWJul 6, 2026NCT06968845lastUpdatePostDate: changed
LOWJul 6, 2026NCT06968845lastUpdatePostDate: changed
LOWJul 2, 2026NCT06968845lastUpdatePostDate: changed
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LOWJul 2, 2026NCT06968845lastUpdatePostDate: changed
LOWJun 29, 2026NCT06968845lastUpdatePostDate: changed
LOWJun 29, 2026NCT06968845lastUpdatePostDate: changed
LOWJun 25, 2026NCT06968845lastUpdatePostDate: changed
LOWJun 25, 2026NCT06968845lastUpdatePostDate: changed
LOWJun 25, 2026NCT06968845lastUpdatePostDate: changed

Frequently asked questions about LTI-03

What is LTI-03 used for in Idiopathic Pulmonary Fibrosis?

LTI-03 is an investigational small molecule being developed for Idiopathic Pulmonary Fibrosis (IPF), a progressive lung disease. It is being studied in patients with IPF, including newly diagnosed patients. The drug is not yet approved and is currently in clinical development, with early-phase trials evaluating its safety and efficacy in this condition.

What does LTI-03 target?

LTI-03 is a small molecule therapeutic being developed for Idiopathic Pulmonary Fibrosis. Its specific molecular target has not been disclosed in available information. The drug is being studied for its potential to treat IPF, a condition characterized by lung scarring and declining respiratory function.

Who makes LTI-03?

LTI-03 is being developed by Rein Therapeutics, Inc., a biopharmaceutical company traded under the ticker symbol RNTX. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in patients with Idiopathic Pulmonary Fibrosis.

What phase is LTI-03 in?

LTI-03 is currently in Phase 2 clinical development for Idiopathic Pulmonary Fibrosis. A Phase 1 study has been completed, and a Phase 2 trial is actively recruiting participants. The drug has received Orphan Drug and Fast Track designations from the FDA, but it is not yet approved.

What clinical trials is LTI-03 in?

LTI-03 has been studied in two clinical trials. NCT05954988 was a completed Phase 1 study in newly diagnosed IPF patients. NCT06968845 is an ongoing Phase 2 study in IPF patients, currently recruiting in the United States, Australia, Germany, Poland, and the United Kingdom.

Is LTI-03 the same as any other drug?

LTI-03 is not known to have any alternative names. It is a distinct investigational small molecule being developed by Rein Therapeutics for Idiopathic Pulmonary Fibrosis. No other names for this drug have been reported in clinical trial registrations.