WHISTLE-PF Trial
Wound-remodeling Hedgehog-inhibitor ILD Study Testing Lung Function Endpoints
A Phase 2 clinical trial for individuals living with IPF
About the WHISTLE-PF Trial
The WHISTLE-PF clinical trial is a randomized, placebo-controlled trial that will further evaluate the therapeutic potential of the investigational treatment, ENV-101 (taladegib) in individuals with idiopathic pulmonary fibrosis (IPF).
This is a double-blind trial, which means neither you nor your trial doctor will know whether you are receiving the active trial medication (or which dose of it) or the placebo. A placebo is a medication with no active ingredients. Participants will have a three out of four chance of receiving ENV-101 (in one of three doses) and a one out of four chance of receiving a placebo.
Patients who qualify for the trial will participate for up to 30 weeks. If participants are on standard-of-care IPF medications (e.g., nintedanib, pirfenidone) at the start of the trial, they are allowed to continue treatment during the trial.
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This trial has three main periods
Screening Period
Timing: up to 28 days
Screening Period
Timing: up to 28 daysThe WHISTLE-PF screening period of up to 28 days will begin with your doctor explaining the trial and any potential risks.
Researchers will conduct assessments and review your medical history to determine if you meet entry criteria and if the trial is deemed suitable for you.
Treatment Period
Timing: 24 weeks
Treatment Period
Timing: 24 weeksIf the WHISTLE-PF trial is suitable for you and you decide to participate, you will enter the treatment period.
This period will last for approximately 24 weeks and you will receive the trial medication or placebo during this time.
Follow-Up Period
Timing: 2 weeks
Follow-Up Period
Timing: 2 weeksThe follow-up period will last for two weeks and during this period you will no longer receive any trial medication or placebo.
You will come back to the clinic two weeks after the last dose of trial medication or placebo so the trial staff can assess your health.
About ENV-101
ENV-101 is an oral medicine being investigated by Endeavor BioMedicines, Inc., to treat fibrotic lung diseases, starting with IPF. ENV-101 blocks a protein in the body that is thought to be involved in lung scarring. By blocking this process, ENV-101 may slow or reverse IPF, which may improve symptoms.
Planned Trial Locations
Find a clinical trial location near you
Understanding Idiopathic Pulmonary Fibrosis
IPF is characterized by progressive scarring in the lungs that develops when the lung tissue becomes thick and stiff for unknown reasons. This process, known as fibrosis, can cause permanent scarring over time and makes it increasingly difficult to breathe. To learn more, see the below community and patient resources.
Community and Patient Resources
About Clinical Trials
Clinical trials help to identify new, investigational treatments and make sure these treatments are safe and effective for use in patients. They are at the heart of medical advances, helping researchers find new ways to diagnose, treat and prevent diseases. People who participate in clinical trials contribute to a better understanding of their disease and are an essential part of identifying new treatments.
About Endeavor BioMedicines
Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases.
