Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of LTI-03 in Patients with IPF
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Efficacy of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Patients with Idiopathic Pulmonary Fibrosis
IRAS ID
1011923
Contact name
Steven Shoemaker
Contact email
Sponsor organisation
Rein Therapeutics, Inc
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to find out if the study drug, LTI-03, or placebo (a solution that does not contain the study drug), can help patients who have Idiopathic Pulmonary Fibrosis (IPF). The aims of this study are to learn more about the study drug, including its safety; the way the body absorbs, distributes, and gets rid of it; how the study drug acts on the body; and whether it works. The researchers want to find out how effective, and tolerable the study drug is and if there are any side effects in participants who have been diagnosed with IPF.
LTI-03 is an investigational drug, which means it is not yet approved by the U.S. Food and Drug Administration (FDA) or the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of IPF. It has been tested in about 71 people so far. This clinical trial will be conducted globally and approximately 120 people who have been diagnosed with IPF within the last 5 years are planned to participate.
Participants will be asked to visit the study site up to 9 times. Participation in this research will last up to 32 weeks and will consist of three parts:
- Screening period (up to 28 days)
- Study Treatment period (24 weeks)
- Follow-up period (4 weeks after last dose of study drug)Participants will be assigned to one of three study treatment groups (LTI-03 low dose, LTI-03 high dose, or placebo). Whether participants receive the study drug, or the placebo will be decided on a random basis. Participants will have a 2 in 3 or 67% chance of receiving the study drug. Both the study drug and placebo are in the form of a capsule. The capsule is filled with dry powder (either LTI-03 or placebo) and the capsule is placed in an inhaler. Participants will take the study drug or placebo twice a day.
Neither the participant nor the study doctor will know if the participant is taking the study drug or the placebo (this procedure is called “double-blind”).
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0144
Date of REC Opinion
12 Aug 2025
REC opinion
Further Information Favourable Opinion