LYT-100 (Deupirfenidone) for Idiopathic Pulmonary Fibrosis

(ELEVATE Trial)

Not currently recruiting at 162 trial locations

Overseen By Wassim Fares, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: PureTech

Disqualifiers: Obstructive airway, Connective tissue, Cardiovascular, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LYT-100 (Deupirfenidone) for individuals with Idiopathic Pulmonary Fibrosis (IPF), a lung disease that causes breathing difficulties. Researchers aim to determine if LYT-100 is safe and effective compared to pirfenidone or a placebo. Participants will be randomly assigned to one of four groups: two different doses of LYT-100, pirfenidone, or a placebo. This trial may suit adults diagnosed with IPF who have not yet received extensive treatment. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients who have been on nintedanib for less than 6 months can participate, suggesting that some medications might be allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LYT-100, also known as Deupirfenidone, was safe in previous studies. Patients tolerated LYT-100 well at various doses, with no major safety issues identified. This treatment is being developed as a potential new option for idiopathic pulmonary fibrosis (IPF) and has demonstrated a positive safety profile so far.

Pirfenidone, already approved for treating IPF, is generally well-tolerated according to studies. The most common serious issue was the worsening of IPF itself, occurring in only a small number of patients. Otherwise, pirfenidone has been safely used by many patients.

Both LYT-100 and pirfenidone have been well-tolerated in studies. However, discussing any concerns with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about LYT-100 (Deupirfenidone) for idiopathic pulmonary fibrosis because it offers a potentially more effective approach compared to current treatments like pirfenidone or nintedanib. LYT-100 is a deuterated form of pirfenidone, meaning it has a unique chemical structure that may enhance its efficacy and reduce side effects. This alteration potentially allows the drug to be taken at lower doses while maintaining its therapeutic effect, which could lead to improved patient tolerance and compliance. By targeting the disease with this novel formulation, LYT-100 may offer a promising new option for patients struggling with existing therapies.

What evidence suggests that this trial's treatments could be effective for Idiopathic Pulmonary Fibrosis?

Research has shown that LYT-100, also known as deupirfenidone, may help treat idiopathic pulmonary fibrosis (IPF). In studies, LYT-100 met its main goal with a 98.5% chance of success, suggesting its effectiveness. It is being developed as a potential new standard treatment for this condition. In this trial, participants may receive LYT-100 at different dosages.

Pirfenidone, another treatment option in this trial, has been shown to slow the worsening of lung function and improve survival without disease progression in IPF patients. It reduces the risk of severe lung function decline or death by 43.8%. This trial studies both treatments for their potential to help people with IPF, offering hope for better outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Camilla Graham, MD

Principal Investigator

PureTech

Are You a Good Fit for This Trial?

This trial is for adults with Idiopathic Pulmonary Fibrosis (IPF) who are new to treatment or have had less than 6 months of a specific drug. They must be able to follow the study's procedures and not use tobacco products, including vaping. People with other lung diseases, recent serious heart issues, hospitalization due to COVID-19 or IPF flare-ups, or certain infections can't join.

Inclusion Criteria

I am willing and able to follow all study procedures.

I have IPF diagnosed by a doctor and haven't used nintedanib for more than 6 months.

Exclusion Criteria

I know the cause of my lung condition, such as radiation or an infection.

I was hospitalized for COVID-19 or a serious lung infection within the last 3 months.

I have a known cause for my lung condition, such as radiation treatment or an autoimmune disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LYT-100, pirfenidone, or placebo daily for up to 183 days

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term extension

Participants may opt into continuation of treatment to evaluate tolerability and long-term safety

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LYT-100
• LYT-100 (Deupirfenidone)
• Pirfenidone
• Placebo

Trial Overview The study is testing LYT-100 against pirfenidone (an existing medication for IPF) and placebo in a randomized, double-blind setup where neither participants nor researchers know who gets which treatment until after the results are collected.

How Is the Trial Designed?

Group I: LYT-100 825 mg TID Experimental Treatment 1 Intervention

LYT-100 (Deupirfenidone) 825 mg TID oral administration

Group II: LYT-100 550 mg TID Experimental Treatment 1 Intervention

LYT-100 (Deupirfenidone) 550 mg TID oral administration

Group III: pirfenidone 801 mg TID Active Control 1 Intervention

pirfenidone 801 mg TID oral administration

Group IV: Placebo Placebo Group 1 Intervention

Placebo oral administration

Who Is Running the Clinical Trial?

PureTech

Lead Sponsor

Trials

7

Recruited

830+

Published Research Related to This Trial

LYT-100 (deupirfenidone) was found to be well tolerated in a phase 1b study with 1000 mg doses administered twice daily, showing only mild and transient adverse events, which suggests a potentially safer profile compared to existing antifibrotic treatments.

The pharmacokinetic profile of LYT-100 demonstrated dose-proportionality and a higher ratio of the parent drug to its metabolite compared to pirfenidone, indicating that deuteration may positively influence its metabolism and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Phase 1 Evaluation of Deupirfenidone, a Novel Deuterium-Containing Drug Candidate for Interstitial Lung Disease and Other Inflammatory and Fibrotic Diseases. Chen, MC., Korth, CC., Harnett, MD., et al.[2022]

In a study of 92 patients with idiopathic pulmonary fibrosis (IPF) receiving pirfenidone, the drug showed an acceptable safety profile, with skin-related (25%) and gastrointestinal (17.5%) adverse events being the most common, leading to discontinuation in 22.5% of cases.

Despite some patients experiencing significant improvements in lung function, the overall decline in lung function (%FVC and %DLCO) was noted over 36 months, highlighting the need for further research through prospective observational registries to better understand pirfenidone's long-term efficacy in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal "Real-World" Outcomes of Pirfenidone in Idiopathic Pulmonary Fibrosis in Greece. Tzouvelekis, A., Karampitsakos, T., Ntolios, P., et al.[2022]

The IFIGENIA trial demonstrated that N-acetylcysteine, when used alongside prednisone and azathioprine, significantly slowed the decline in lung function in patients with idiopathic pulmonary fibrosis over 12 months.

Pirfenidone is the first approved antifibrotic drug for idiopathic pulmonary fibrosis in the EU, showing efficacy in slowing lung function decline and reducing disease progression in over 1,100 patients across four clinical trials, though it may cause side effects like gastrointestinal discomfort and skin reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of pulmonary fibrosis. New substances and new interventions]. Costabel, U., Bonella, F.[2021]

In a real-world study of patients with Idiopathic Pulmonary Fibrosis (IPF), both pirfenidone and nintedanib were found to have common side effects, primarily gastrointestinal, but these were manageable in most cases.

Despite treating older patients with more severe disease and additional health issues, the discontinuation rates due to side effects were similar to those observed in clinical trials, supporting the safety and efficacy of these treatments in broader patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real World Experiences: Pirfenidone and Nintedanib are Effective and Well Tolerated Treatments for Idiopathic Pulmonary Fibrosis. Hughes, G., Toellner, H., Morris, H., et al.[2020]

Citations

1. news.puretechhealth.com news.puretechhealth.com/news-releases/news-release-details/puretech-presents-new-data-phase-2b-open-label-extension-study

PureTech Presents New Data from Phase 2b Open-Label ... These new results showed that participants who completed 26 weeks of placebo or pirfenidone treatment in the randomized portion of the trial and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05321420

LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) This study is a randomized, double-blind, being conducted at centers globally to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo.

3. biospace.com biospace.com/press-releases/puretech-presents-new-phase-2b-analyses-demonstrating-consistent-safety-and-efficacy-of-deupirfenidone-in-older-patients-with-idiopathic-pulmonary-fibrosis-ipf-a-historically-undertreated-group

PureTech Presents New Phase 2b Analyses ... Deupirfenidone (LYT-100) is in development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). It is a ...

4. puretechhealth.com puretechhealth.com/programs/details/lyt-100

LYT-100 The trial achieved its primary endpoint based on the prespecified Bayesian analysis, with a 98.5% posterior probability. This means there is a 98.5% probability ...

5. publications.ersnet.org publications.ersnet.org/content/erjor/early/2025/07/03/2312054100469-2025

A dose-finding pharmacokinetics study of deupirfenidone (LYT ... Phase 1 demonstrates LYT-100 (deupirfenidone) is dose-proportional and well-tolerated when given twice-daily over multiple ascending doses (MAD) ...

6. journal.chestnet.org journal.chestnet.org/article/S0012-3692(23)04411-2/fulltext

DEUPIRFENIDONE (LYT-100) DOSE-SELECTION ... This study will assess safety of LYT-100 550mg TID and 825mg TID and pulmonary function changes from baseline relative to PBO and PIRF.