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LTI-03

Phase 2

Idiopathic Pulmonary Fibrosis (IPF) | Small molecule | Respiratory |Rein Therapeutics, Inc.|Last Updated: Jul 23, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment120
FDA Designations
ORPHAN_DRUG
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 Sites30

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)
LOWJul 24, 2026NCT06968845lastUpdatePostDate: changed
LOWJul 24, 2026NCT06968845lastUpdatePostDate: changed
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LOWMay 26, 2026NCT06968845primaryCompletionDate: changed
LOWMay 24, 2026NCT06968845studyFirstPostDate: changed