Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF) (NCT06967805) is a Phase 2 interventional studying Idiopathic Pulmonary Fibrosis, sponsored by Mediar Therapeutics. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Idiopathic Pulmonary Fibrosis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 164 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Idiopathic Pulmonary Fibrosis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants with IPF of any gender ≥ 40 years of age at time of signing the willing to sign a consent form. - Able to understand the study and provide signed, written willing to sign a consent form. - Able to read and understand the language of the willing to sign a consent form and other trial-related materials. - Meet the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association (ATS/ERS/JRS/ALAT) 2019 criteria for the diagnosis of IPF; Diagnosed with IPF within 7 years of screening. - If a participant is on treatment with pirfenidone or nintedanib, the dose of the medication must be stable for ≥ 90 days prior to Screening with plans to maintain the same dose throughout the study treatment period. Use of both agents together is not permitted. - If a participant was on treatment with nintedanib or pirfenidone, and the agent has been discontinued, this must have occurred ≥ 30 days prior to Screening. At Screening, there must also be no plan to start either of these medications for the duration of the study. - FVC of ≥ 45 percent predicted (pp) at screening. - DLCO of ≥ 25pp at screening. - Willing and able to complete all protocol required study visits and procedures. - All participants of childbearing potential must have a negative serum pregnancy test at Screening. - Participants with reproductive potential must agree to use and follow medically approved contraceptive precautions during the study Who Should NOT Join This Trial: - Acute exacerbation of IPF within 6 months of Screening or during the Screening Period. - Forced expiratory volume in 1 second (FEV1)/FVC ratio of \<0.7 at Screening. - Requirement for continuous supplemental oxygen. Intermittent supplemental oxygen use (e.g., during exercise or sleep) is permitted. - Expected to receive a lung transplant within the study duration. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Participants with IPF of any gender ≥ 40 years of age at time of signing the informed consent. * Able to understand the study and provide signed, written informed consent. * Able to read and understand the language of the informed consent and other trial-related materials. * Meet the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association (ATS/ERS/JRS/ALAT) 2019 criteria for the diagnosis of IPF; Diagnosed with IPF within 7 years of screening. * If a participant is on treatment with pirfenidone or nintedanib, the dose of the medication must be stable for ≥ 90 days prior to Screening with plans to maintain the same dose throughout the study treatment period. Use of both agents together is not permitted. * If a participant was on treatment with nintedanib or pirfenidone, and the agent has been discontinued, this must have occurred ≥ 30 days prior to Screening. At Screening, there must also be no plan to start either of these medications for the duration of the study. * FVC of ≥ 45 percent predicted (pp) at screening. * DLCO of ≥ 25pp at screening. * Willing and able to complete all protocol required study visits and procedures. * All participants of childbearing potential must have a negative serum pregnancy test at Screening. * Participants with reproductive potential must agree to use and follow medically approved contraceptive precautions during the study Exclusion Criteria: * Acute exacerbation of IPF within 6 months of Screening or during the Screening Period. * Forced expiratory volume in 1 second (FEV1)/FVC ratio of \<0.7 at Screening. * Requirement for continuous supplemental oxygen. Intermittent supplemental oxygen use (e.g., during exercise or sleep) is permitted. * Expected to receive a lung transplant within the study duration. * Current active bacterial infection or use of antibiotics for suspected lung infection in the 30 days prior to Screening. * Planned surgery within the study duration. * Clinically significant pulmonary hypertension. * Use of immunosuppressive therapy (excluding corticosteroids). If previously on such agents, they should have been discontinued for at least 5 half-lives or 90 days, whichever is longer, prior to Screening. * Use of systemic corticosteroids (prednisone or equivalent) at a dose ≥ 10 mg once daily within 30 days of Screening. * Currently smoking or vaping. * Current known malignancy, or history of cancer, or lymphoproliferative disorder other than non-melanomatous skin cancers, within 2 years of Screening. * Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). * Currently pregnant, breast feeding, or planning to conceive for the length of the study. * History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 2 years of Screening. * Any clinically significant disease or laboratory abnormality detected at Screening that might interfere with a participant's ability to complete the study, on-study evaluations, or participant safety. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2× upper limit of normal (ULN) at Screening. * Any other concurrent active medical condition determined by the Investigator to interfere with participant's ability to complete the trial. * Known allergy to MTX-463 or any of its excipients. * Any prior use of MTX-463 or other therapy targeting WISP1. * Any other concurrent experimental agent or an active part of any other clinical trial, unless they have stopped taking the investigational product at least 5 half-lives or 30 days before Screening, whichever is longer.

Treatments Being Tested

BIOLOGICAL

MTX-463

MTX-463 is an immunoglobin G1 (IgG1) monoclonal antibody directed against WNT-inducible signaling pathway protein 1 (WISP1). WISP1 (aka CCN-4) is a matricellular protein that appears to be upregulated locally in response to certain chronic diseases, including IPF, and malignancies.

OTHER

Placebo

Placebo

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

WISPer Site in Birmingham, AL
Birmingham, Alabama, United States
WISPer site in Phoenix, AZ
Phoenix, Arizona, United States
WISPer Site in Los Angeles, CA
Los Angeles, California, United States
WISPer site in Newport Beach, CA
Newport Beach, California, United States
WISPer Site in Palm Springs, CA
Palm Springs, California, United States
WISPer Site in Denver, CO
Denver, Colorado, United States
WISPer site in Loxahatchee, FL
Loxahatchee Groves, Florida, United States
WISPer Site in Atlanta, GA
Atlanta, Georgia, United States
WISPer site in Champaign, IL
Champaign, Illinois, United States
WISPer site in Kansas City, KS
Kansas City, Kansas, United States
WISPer Site in Louisville, KY
Louisville, Kentucky, United States
WISPer site in Shreveport, LA
Shreveport, Louisiana, United States
WISPer Site in Baltimore, MD
Baltimore, Maryland, United States
WISPer Site in Boston, MA
Boston, Massachusetts, United States
WISPer Site in Ann Arbor, MI
Ann Arbor, Michigan, United States
WISPer Site in Detroit, MI
Detroit, Michigan, United States
WISPer site in New York, NY
New York, New York, United States
WISPer Site in Durham, NC
Durham, North Carolina, United States
WISPer site in Greensboro, NC
Greensboro, North Carolina, United States
WISPer site in Oklahoma City, OK
Oklahoma City, Oklahoma, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06967805), the sponsor (Mediar Therapeutics), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06967805 clinical trial studying?

A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF) The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06967805?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06967805?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06967805. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06967805. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.