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)
Idiopathic pulmonary fibrosis (IPF) is a long-term condition where lung tissue becomes scarred and stiff, making it difficult to breathe. The WHISTLE-PF trial is testing a new investigational drug called ENV-101 (also known as taladegib) to find out if it is safe and effective. In this Phase 2 trial, researchers are comparing ENV-101 tablets against an identical-looking dummy pill (placebo). Neither you nor your study doctor will know which one you receive. The main goal is to measure changes in your lung capacity—how much air your lungs can hold—after 24 weeks of treatment. Doctors will also check whether the medicine helps reduce common, troublesome symptoms such as persistent coughing, shortness of breath, and fatigue. Taking part involves regular clinic visits, breathing checks, and close health monitoring by a specialist team.
At a glance
What is this study about?
Idiopathic pulmonary fibrosis, or IPF, causes gradual scarring inside the lungs. Over time, this scarring makes the lungs stiffer and less able to take in oxygen. People living with IPF often experience worsening breathlessness, a dry cough that will not go away, and severe fatigue. Current treatments can help slow down the condition, but new and better options are urgently needed to improve quality of life and protect lung health.
The WHISTLE-PF study is researching a medicine called ENV-101 (taladegib). Scientists want to find out whether blocking specific signals involved in tissue scarring can stop or slow down the damage caused by IPF. By testing this medicine in people, researchers hope to see whether it can keep the lungs working better for longer.
Because this is a Phase 2 study, its main focus is to explore whether the medicine works as hoped and to check for any unwanted side effects. The results will give doctors valuable information on whether ENV-101 should move forward into larger, final-stage clinical trials. If successful, it could one day become a new treatment choice for people diagnosed with this challenging lung condition.
Key takeaways
- The study tests an experimental tablet (ENV-101) for idiopathic pulmonary fibrosis.
- It aims to find out if the drug preserves lung capacity and eases symptoms over 24 weeks.
- Participants take either the active medicine or a matching dummy pill (placebo).
- Open to adults aged 18 and older diagnosed with IPF.
- Participation is entirely voluntary, and you can withdraw at any point.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with idiopathic pulmonary fibrosis (IPF). Both men and women can take part.
To join, participants generally need to have lung function within a specific range so that doctors can safely measure any changes during the study. You will also need to be well enough to attend regular hospital appointments and perform standard breathing tests.
You might not be able to take part if you have certain other serious medical conditions, such as severe heart problems, or if you are taking medications that could interfere with the study drug. Your hospital doctor or the study team will review your full medical history to confirm whether the trial is safe and suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with idiopathic pulmonary fibrosis (IPF).
- I am able to take daily tablets by mouth.
- I can travel to a study hospital for regular check-ups over at least six months.
- I am willing and able to complete regular breathing tests.
What does participation involve?
Taking part in this study lasts for at least 24 weeks (around six months). If you join, you will be randomly assigned by a computer to take either the study drug (ENV-101) or a placebo tablet each day. The tablets are small, aquamarine-coloured, and taken by mouth. You will have regular visits at the hospital or clinic so the medical team can monitor your health. These visits will include lung function tests (blowing into a machine to see how much air your lungs hold), blood tests, physical exams, and answering short questionnaires about your cough, breathlessness, and energy levels.
Potential risks and benefits
Locations (6)
- —UnverifiedBelgium
- —UnverifiedIreland
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedAustria
- —UnverifiedFrance
Common questions
What is a placebo and why is it used?
A placebo is a dummy tablet that looks identical to the real medicine but contains no active ingredients. It helps researchers prove whether any improvements or side effects are truly caused by the study drug.
Can I choose whether I receive the real medicine or the placebo?
No. A computer assigns you to a group by chance (randomisation). Neither you nor your doctor will know which treatment you are taking during the study.
Will taking part cost me anything?
No. The study medication, tests, and doctor visits are provided free of charge. Most trials also offer help with travel expenses to and from the clinic.
Can I keep taking my normal IPF medicines?
This depends on the specific rules of the trial. The study doctor will review all your current prescriptions to check which ones are safe to continue.
What happens if I feel worse during the study?
Your health is closely monitored throughout the trial. If your condition worsens or you experience unpleasant side effects, the study doctor can adjust your care or stop the study treatment immediately.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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