Clinical Trials/NCT05954988

NCT05954988CompletedPhase 1

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Safety, Tolerability and Pharmacodynamic Biomarker Study of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Recently Diagnosed, Treatment Naïve Subjects With IPF

Rein Therapeutics7 sites in 3 countries24 target enrollmentStarted: July 6, 2023Last updated: July 31, 2025

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Rein Therapeutics
Enrollment: 24
Locations: 7
Primary Endpoint: Incidence of Treatment-emergent Adverse Events (TEAEs)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials Related News

Study Overview

Brief Summary

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

Detailed Description

This is a randomized, double-blind, placebo controlled, multi-center, dose escalation, safety and tolerability study of LTI-03 or placebo administered by inhalation in participants recently diagnosed with idiopathic pulmonary fibrosis that have not received prior treatment with anti-fibrotic agents.

The study will contain 2 dose cohorts which will run sequentially.

Eligible participants will be randomized in a 3:1 ratio to either LTI-03 or placebo. Safety data will be reviewed on an ongoing basis. Enrollment in the second cohort will not begin until the Cohort 1 safety data has been reviewed.

The Treatment Period will be 14 days, with subjects self-administering study drug using a provided commercially available dry-powder inhaler.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential
Primary Purpose: Other
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

The Sponsor, Investigator, and study personnel working on behalf of the Investigator and Sponsor will remain blinded.

Eligibility Criteria

Ages: 40 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•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 ≤
•Forced expiratory volume 1 (FEV1)/FVC ≥ 0.7.

Exclusion Criteria

•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.
•Female subjects 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 subjects who do not agree to refrain from donating sperm during this same period.

Arms & Interventions

2.5 mg LTI-03 BID

Experimental

2.5 mg LTI-03 BID x 14 days

Intervention: LTI-03 (Drug)

5 mg LTI-03 BID

Experimental

5 mg LTI-03 BID x 14 days

Intervention: LTI-03 (Drug)

Placebo

Placebo Comparator

Matching placebo BID x 14 days

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Incidence of Treatment-emergent Adverse Events (TEAEs)

Time Frame: 21 days (dosing x 14 days; follow up x 7 days)

Incidence of TEAEs by dose

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor

Rein Therapeutics

Sponsor Class

Industry

Responsible Party

Sponsor

Study Sites (7)

Loading locations...

Similar Trials

Completed

Phase 1

Safety, Tolerability and Pharmacokinetic Study of LTI-03 in Healthy Adult SubjectsIdiopathic Pulmonary Fibrosis

NCT04233814Lung Therapeutics, Inc71

Completed

Phase 3

Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 DiabetesDiabetes Mellitus, Type 2

NCT01084005Boehringer Ingelheim241

Completed

Phase 3

Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2

NCT00954447Boehringer Ingelheim1,263

Completed

Phase 3

Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal ImpairmentDiabetes Mellitus, Type 2

NCT01087502Boehringer Ingelheim241

Completed

Phase 3

Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent AsthmaAsthma

NCT01634139Boehringer Ingelheim403