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Evaluating ENV-101 for lung fibrosis treatment

A Phase 2, Multi-Center, Randomized, Double-Blind, Controlled Trial Evaluating the Safety and Efficacy of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)

Phase 2 Interventional Endeavor Biomedicines, Inc. · NCT06422884

This study is testing if a new medication called ENV-101 can improve lung function in adults with idiopathic pulmonary fibrosis while they continue their usual treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages40 Years and up
SexAll
SponsorEndeavor Biomedicines, Inc. Industry-sponsored
Drugs / interventionstocilizumab, rituximab, Radiation, cyclophosphamide
Locations80 sites (Quilmes, Buenos Aires and 79 other locations)
Trial IDNCT06422884 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effects of ENV-101 on lung function and fibrosis in adults diagnosed with idiopathic pulmonary fibrosis (IPF). It is a 6-month, randomized, double-blind, controlled trial where participants will receive either ENV-101 at varying doses or a placebo. Patients may continue their standard care treatments during the trial, allowing for a comprehensive evaluation of ENV-101's efficacy and safety. The study will help determine the appropriate dose for future Phase 3 trials.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with a confirmed diagnosis of idiopathic pulmonary fibrosis and specific lung function criteria.

Not a fit: Patients with other known causes of interstitial lung disease or significant respiratory impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve lung function and quality of life for patients with idiopathic pulmonary fibrosis.

How similar studies have performed: While this approach is novel in the context of ENV-101, similar studies targeting the hedgehog pathway in pulmonary fibrosis have shown promise.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patients ≥ 40 years old with an IPF diagnosis as confirmed by the Investigator.
* Percent predicted FVC of ≥ 45% at study start.
* Percent predicted diffusing capacity of lung for carbon monoxide (DLCO) ≥ 25%, adjusted for hemoglobin (Hgb) at study start.
* Ability to perform spirometry tests.
* Either stable treatment with standard of care (SoC) \[i.e., antifibrotics, immunosuppressants (PPF only)\] for at least 3 months prior to study start or not treated with SoC for at least 8 weeks prior to study start.

Exclusion Criteria:

* Evidence of other known causes of interstitial lung disease (ILD).
* Forced expiratory volume in one second (FEV1)/FVC ratio \<0.7 at study start.
* History of malignancy, including carcinoma during the preceding 5 years from study start, with the following exceptions:

  1. Prior history of in situ melanoma, basal or squamous cell skin cancer if treated with curative therapy.
  2. Patients with prostate cancer that are managed by surveillance.
  3. Patients with ductal carcinoma in situ, treated surgically with curative intent.
* Patients with moderate to severe hepatic impairment (Child-Pugh B and C).
* Smoking (including vaping) within 6 months of study start; current smoker, or unwillingness to refrain from smoking during the clinical trial duration.
* Active or suspected alcohol or drug abuse in the opinion of the Investigator.
* Currently enrolled in another investigational device or drug trial, or less than 3 months from study start since ending another investigational device or drug trial(s) or receiving other investigational treatment(s).
* Presence of active infection at study start or confirmed active human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
* Major surgery requiring hospitalization (according to the Investigator) performed within 3 months prior to study start or planned during the course of the trial. Being on a transplant list is allowed.
* Occurrence of serious illness requiring hospitalization within 90 days prior to study start.
* Current or previous use (within 28 days prior to study start) of the following:

  1. Endothelin receptor antagonist
  2. Riociguat
  3. Prostacyclin or prostacyclin analogue
  4. Radiation to the lungs
  5. Oral corticosteroids \>15 mg/day
* Use of cyclophosphamide or tocilizumab within 8 weeks, or rituximab within 6 months, prior to study start.
* Use of drugs that are known moderate or stronger CYP3A4 inhibitors or inducers within 14 days prior to study start. Patients must also agree not to eat fruits that inhibit CYP3A4 such as grapefruit, Seville oranges, pomelo and star fruit.
* Patients of reproductive potential who are sexually active and unwilling to use birth control for the duration of the study and for 3 months after their final dose of study drug.
* Females that are pregnant or nursing.
* Patients that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final dose of study drug.
* Males who are unwilling to refrain from sperm donation and females who are unwilling to refrain from egg donation for the duration of the study and for 3 months after their final dose of study drug.
* Patients with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of ENV-101.
* Patients who have previously taken ENV-101.

Where this trial is running

Quilmes, Buenos Aires and 79 other locations

+30 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Idiopathic Pulmonary FibrosisProgressive Fibrosing Interstitial Lung Diseasetaladegibhedgehog pathway inhibitorpulmonary fibrosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.